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There is an urgent need to identify modifiable mechanisms contributing to risk and vulnerability among youth. The investigators test the hypothesis that eveningness, the tendency to go to sleep late and wake late, is an important contributor to, and even cause of, vicious cycles that escalate vulnerability and risk among youth. This study seeks to determine whether two interventions to reduce eveningness can reduce risk and confer resilience in critical aspects of health, development and functioning in youth.
Teens who exhibit a circadian tendency toward eveningness ('night-owls') follow a delayed sleep schedule, increasing activity later in the day and both going to sleep and getting up later, compared to morning-types ('larks'). The circadian tendency toward eveningness during adolescence arises from a confluence of psychosocial, behavioral and biological factors and is an important contributor to, and maybe even cause of, vicious cycles that escalate vulnerability and risk for poor health and major forms of psychopathology. Indeed, an evening circadian tendency has been associated with a wide range of adverse effects including poorer health, poorer academic performance, poorer self-regulation, greater use of substances, greater tendency for impulsivity, more depression and anxiety, greater emotional instability and more aggressive and antisocial behavior. While the biological shift toward eveningness during puberty may be difficult to modify, the psychosocial and behavioral contributors are modifiable. Moreover, modifying these contributors will eliminate key factors that exacerbate the biological shift. The proposed research will advance current knowledge on the role of eveningness as a mechanism contributing to poorer outcomes during adolescence. The investigators aim to reduce eveningness among 10-18 year olds via an intervention which integrates evidence-based treatments derived from basic research on the circadian system (Treatment 1) compared to a psychoeducational intervention that highlights the interplay between sleep, diet, exercise and stress (Treatment 2). The investigators will randomly allocate adolescents with an evening circadian tendency, and who are 'at risk' in at least one of five health domains (emotional, cognitive, behavioral, social, physical), to either: (a) Treatment 1 (n = 86) or (b) Treatment 2 (n = 86). Measures will be taken pre-treatment, post-treatment, and at 6 and 12 months post-treatment. This research is a first step within a longer term plan to accelerate knowledge on the potentially powerful positive effects, for the developing neural system, of simple, disseminable psychosocial interventions specifically designed to target modifiable risk factors across adolescence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental | Integrates evidence-based treatments derived from basic research on the circadian system |
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| Treatment 2 | Active Comparator | Psychoeducation on the inter-associations between sleep, diet, exercise and stress. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy | Behavioral |
| ||
| Psychoeducation |
| Measure | Description | Time Frame |
|---|---|---|
| Total Sleep Time (TST) Average on Weeknights Via Daily Sleep Diary | Total sleep time (TST) average on weeknights via Daily Sleep Diary. Change from baseline to post-treatment. The model provides estimates of the mean pre-post change in the Psychoeducation (PE) condition and the TranS-C condition. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
| Average Bedtime on Weeknights Measured Via Daily Sleep Diary | Change in average bedtime on weeknights from pre-treatment to post-treatment measured via Daily Sleep Diary. 24-hour decimal format, where times after midnight are expressed as numbers above 24 (ex. 1:30 am is 25.50). The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
| Morning Eveningness Preference Measured Via Childrens Morningness Eveningness Preference Scale | Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale(CMEP). Scores range from 10 (Extreme evening preference) to 43 (Extreme morning preference). The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
| Composite Score for Cognitive Domain | Cognitive composite score reflects cognitive functioning and was calculated by averaging the standardized summary scores from two measures: Attentional Control Scale (ACS) and Youth Social Adjustment Scale-Self Report (YSAS). Summary scores were calculated as 1.)ACS = sum of 20 items rated 1- 4; range: 20-80. Higher scores indicate less attentional control; and 2.) YSAS = sum of 6 school/cognitive-related items rated 1-5; range: 6-30. Higher scores indicate worse school-related impairment. Per participant, summary scores from the ACS and YSAS were computed and then standardized. The final composite (range -2.12 to 2.39) was calculated as the mean of the two standardized scores. Higher scores indicate greater attentional difficulty and school impairment. Change in this composite score from baseline to post treatment is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleepiness Scale | Sleepiness subscale from School Sleep Habits Survey (SSHB). This subscale includes 10 items rated on a 4-point scale (0 - 3), assessing sleepiness. Total scores were calculated by summing all item responses. Possible scores range from 0 to 30, with higher scores indicating greater daytime sleepiness. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of Psychiatric Disorders | Measured via Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS) Interview | Baseline only |
| Diagnosis of Sleep Disorders | Measured via Duke Structured Interview for Sleep Disorders |
Inclusion criteria.
Exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Allison G Harvey, PhD | University of California, Berkeley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Berkeley | Berkeley | California | 94720 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31773734 | Derived | Dong L, Dolsen MR, Martinez AJ, Notsu H, Harvey AG. A transdiagnostic sleep and circadian intervention for adolescents: six-month follow-up of a randomized controlled trial. J Child Psychol Psychiatry. 2020 Jun;61(6):653-661. doi: 10.1111/jcpp.13154. Epub 2019 Nov 26. | |
| 31678861 | Derived | Gumport NB, Dolsen EA, Harvey AG. Usefulness and utilization of treatment elements from the Transdiagnostic Sleep and Circadian Intervention for adolescents with an evening circadian preference. Behav Res Ther. 2019 Dec;123:103504. doi: 10.1016/j.brat.2019.103504. Epub 2019 Nov 1. |
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Based in a university clinic, from March 2013 to March 2016, youth were randomly assigned, stratified by sex and age (10-14 years, 15-18 years), in a 1:1 parallel group design, to receive either Transdiagnostic Sleep and Circadian Intervention (TranS-C) or Psychoeducation (PE). Sibling pairs (n = 3) were randomized to the same condition.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trans-C | Integrates evidence-based treatments derived from basic research on the circadian system Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy |
| FG001 | Psychoeducation | Psychoeducation on the inter-associations between sleep, diet, exercise and stress. Psychoeducation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Youth aged 10 to 18 years with an evening chronotype and who were "at risk" in 1 of 5 health domains. Participants included 176 youth recruited through clinicians or advertisements.
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| ID | Title | Description |
|---|---|---|
| BG000 | Trans-C | Integrates evidence-based treatments derived from basic research on the circadian system Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy |
| BG001 | Psychoeducation |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Sleep Time (TST) Average on Weeknights Via Daily Sleep Diary | Total sleep time (TST) average on weeknights via Daily Sleep Diary. Change from baseline to post-treatment. The model provides estimates of the mean pre-post change in the Psychoeducation (PE) condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | Minutes | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
|
Through study completion, an average of 1 year.
All-cause mortality, Serious, and Other (Not Including Serious) Adverse Events were monitored through occasional assessment and self-report.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trans-C | Integrates evidence-based treatments derived from basic research on the circadian system Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor of Clinical Psychology | University of California, Berkeley | 5104736490 | aharvey@berkeley.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2019 | Mar 18, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D019454 | Chronotherapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D013812 | Therapeutics |
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| Behavioral |
|
| Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
| Composite Score for Behavioral Domain | To assess functioning in the Behavioral domain, a Youth Self-Report Composite Risk Score is calculated by taking the mean of standardized summary scores from two measures: Sensation Seeking Scale for Children (SSS) and the Alcohol and Substance Use-Past 30 days (SU; items include questions on caffeine and energy drinks). Summary scores were calculated as 1.) SSS = sum of 8 items, rated 1-5, range: 8-40. Higher scores = greater sensation seeking; and 2.) SU = Sum of 23 items rated 0-7, range 0-161. Higher scores = more frequent use. For each participant, summary scores from the SSS and SU subscales were computed and standardized. The final composite (range -1.73 to 3.34) was calculated as the mean of the two standardized scores. Higher composite scores indicate higher impairment Change in this composite score from baseline to post-treatment is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
| Composite Score for Emotional Domain | Youth Self-Report Composite Score, Emotional functioning domain is calculated by taking the mean of standardized summary scores from two measures: Children's Depression Rating Scale-Revised (CDRS) and the Multidimensional Anxiety Scale for Children (MASC). Summary scores were calculated as 1.) CDRS = Sum of 17 items. range 17-113. Higher scores indicate greater depressive symptoms; and 2.) MASC= Sum of 39 items. range 0-117. Higher scores indicate greater anxiety. For each participant, summary scores from the CDRS and MASC subscales were first computed and then standardized. The final composite (range -2.10 to 3.60) was calculated as the mean of the two standardized scores from the CDRS and MASC. Higher composite scores indicate greater emotional risk (i.e., more depression and anxiety symptoms). Change in this composite score from baseline to post treatment is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
| Composite Score for Social Domain | Composite Score for Social Domain to assess functioning in the Social domain. Calculated by taking the average of the three subscales (ie, friends, family, romantic relationships) from the Youth Social Adjustment Scale - Self Report. Youth Social Adjustment Scale - social items only. 9 items (questions 7-15 out of the 23 item scale), item range 1-5. Summary score is calculated by taking the sum of all 9 items. no reverse coding needed. Summary score range 9-45. Higher score = more impaired adjustment. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
| Composite Score for Physical Domain | Composite Score for Physical Domain (physical functioning) is calculated by taking the mean of standardized summary scores from two measures: Modifiable Activity Questionnaire for Adolescents (MAQ) and Physical Health Questionnaire (PHQ). Summary scores were calculated as 1.) MAQ = sum of the number of hours per week not active/exercising. Higher scores indicate greater numbers of leisure hours; and 2. PHQ-15 = sum of item (13 items for males, 14 items for females), range 0-30. Higher scores indicate worse somatic complaints. For each participant, summary scores from the MAQ and PHQ-15 subscales were first computed and then standardized. The final composite (range -3.95 to 1.86) was calculated as the mean of the two standardized scores. Higher composite scores indicate greater physical health risk. Change in this composite score from baseline to post treatment is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
| Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups |
| Dim Light Melatonin Onset | Melatonin levels were measured using 13 saliva samples collected at 30-minute intervals, beginning 5.5 hours before and ending 30 minutes after each participant's average bedtime (computed from 7 nights of sleep diary). For each timepoint (baseline and post-treatment), the dim light melatonin onset (DLMO) was estimated by identifying when melatonin levels crossed the 3.0 pg/ml threshold (i.e., the interpolated time). Change in the interpolated DLMO times from baseline to post treatment (which is an average of 9 weeks after the beginning of treatment) reported. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Pittsburgh Sleep Quality Index | Pittsburgh Sleep Quality Index (PSQI). Summary score is calculated by taking the sum of item-level scores. Summary score range 0-21. A higher score means increased severity of difficulty in all sleep area components. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
| Discrepancy Between Weeknights and Weekends for Total Sleep Time | The discrepancy between weeknights and weekends for Total Sleep Time(TST). The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment. |
| Composite Risk Score of Functioning in Five Health-relevant Domains: Emotional Health (Positivity Ratio) | Composite Risk Score of Functioning in Emotional Health, measured via Ecological Momentary Assessment (EMA), assesses subjective emotional well-being across 7-days, per timepoint using a 9-item short form of the Positive and Negative Affect Scale for Children (PANAS-C), which included 4 positive affect items (min = 4, max = 20; higher scores indicate more positive affect) and 5 negative affect items (min = 5, max = 25; higher scores indicate more negative affect), each rated on a 5-point Likert scale. A positivity ratio was calculated by dividing the sum of each affect item scores by the sum of negative affect score per survey day. Higher positivity ratios (range: 0.16-4) indicate higher subjective well-being and less risk. Change in average Positivity Ratio from baseline to post treatment (which is an average of 9 weeks after the beginning of treatment) reported. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment. |
| Child Behavior Checklist: Parent-report Emotional Health Composite Risk Score | Parent Measure. The Emotional Health Composite Risk Score was assessed with a composite score of the Anxious/Depressed and Withdrawn/Depressed subscales of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's emotional health, including items related to anxiety/depression. Range for composite total: 0-42, with higher scores indicating more problems. The CBCL Anxious/Depressed subscale is composed of 13-items CBCL items on a scale of 0-2, the range of scores is 0-26, with higher scores indicating more emotional problems. The CBCL Withdrawn/Depressed subscale is composed of 8-items CBCL items on a scale of 0-2, the range of scores is 0-16, with higher scores indicating more emotional problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition | Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment. |
| Discrepancy Between Weeknights and Weekends for Bedtime Via Daily Sleep Diary | The discrepancy between weeknights and weekends for Bedtime(BT) via Daily Sleep Diary. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment. |
| Discrepancy Between Weeknights and Weekends for Wake Time Via Daily Sleep Diary | The discrepancy between weeknights and weekends for Wake time (WUP) via Daily Sleep Diary. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment. |
| Composite Risk Score of Functioning in Five Health-relevant Domains: Cognitive Health | Composite Risk Score of Functioning in Cognitive Health measured via Ecological Momentary Assessment. Participants responded to 11 items that measured their concentration, distractedness, and focus related to their current activity. All items were rated on 5-point Likert scale, where higher scores respectively indicated higher levels of concentration, distractedness, and focus (min = 11, max = 55). The composite risk score was calculated by averaging participant responses over the assessment week. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Composite Risk Score of Functioning in Five Health-relevant Domains: Behavioral Health | Composite Risk Score of Functioning in Behavioral Health measured via Ecological Momentary Assessment was assessed by directly asking participants about eating, drinking, chewing gum, and smoking behavior at the time the phone rang through 6 open-ended EMA questions. Responses were coded. The average weekly frequency of intake of junk food, caffeine, alcohol, nicotine, and other substances was tabulated. The minimum score was 0, and there was no maximum score. Higher scores indicate more risky behaviors and thus more risk. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Composite Risk Score of Functioning in Five Health-relevant Domains: Physical Health | Composite Risk Score of Functioning in Physical Health derived from Ecological Momentary Assessment (EMA). For the physical health domain, responses to a single daily item (e.g., "Were you physically active today?") were used to create a binary score: 1 = active, 2 = inactive. Daily responses were collected over 7 days and both summed (range: 7-14) and averaged for each participant. The final composite score reflects the average of these daily values (range: 1 - 2) , where lower scores indicate greater physical activity and lower physical health risk. Change in this composite score from baseline to post treatment (which is an average of 9 weeks after the beginning of treatment) is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Composite Risk Score of Functioning in Five Health-relevant Domains: Social Health | Composite Risk Score of Functioning in Social health measured via Ecological Momentary Assessment was assessed by directly asking participants who the participant was with at the time the phone rang. Participants' responses were then manually coded for companion type on a scale of 0-4. Participants' positivity ratios, as calculated in the Emotional Health (Positivity Ratio) Composite Risk Score of Functioning, were then grouped based on occasions when participants were alone vs. with a family member vs. with a friend vs. other. Positivity ratios within groups were averaged (min = 0.16, max = 4), where higher averages indicated higher subjective well-being and lower risk. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Child Behavior Checklist: Parent-report Cognitive Health Composite Risk Score | Parent Measure. Cognitive Health Composite Risk Score was assessed with the Thought Problems and Attention Problems subscale of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's cognitive health, including items related to thought problems. Range for composite total: 0-50, with higher scores indicating more cognitive problems. The CBCL Thought Problems subscale is composed of 15-items CBCL items on a scale of 0-2, the range of scores is 0-30, with higher scores indicating more problems. The CBCL Attention Problems subscale is composed of 10-items CBCL items on a scale of 0-2, the range of scores is 0-20, with higher scores indicating more problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
| Child Behavior Checklist: Parent-report Behavioral Health Composite Risk Score | Parent Measure. The Behavioral Health Composite Risk Score was assessed with a composite score of the Rule-Breaking Behavior and Aggressive Behavior subscales of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's behavioral health, including items related to rule-breaking. Range for composite total: 0-70, with higher scores indicating more behavioral problems. The CBCL Rule-Breaking Behavior subscale is composed of 17-items CBCL items on a scale of 0-2, the range of scores is 0-34, with higher scores indicating more rule-breaking behavior. The CBCL Aggressive Behavior subscale is composed of 18-items CBCL items on a scale of 0-2, the range of scores is 0-36, with higher scores indicating more aggressive behavior. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
| Child Behavior Checklist: Parent-report Social Health Composite Risk Score | Parent Measure. The Social Health Composite Risk Score was assessed with a composite score of the Social Problems subscale of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's social health. The CBCL Social Problems subscale is composed of 11-items CBCL items on a scale of 0-2, the range of scores is 0-22, with higher scores indicating more Social problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
| Child Behavior Checklist: Parent-report Physical Health Composite Risk Score | Parent Measure. The Physical Health Composite Risk Score was assessed with a composite score of the Somatic Complaints subscale of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's Physical health (e.g., "vomiting"). The CBCL Somatic Complaints subscale is composed of 11-items CBCL items on a scale of 0-2, the range of scores is 0-22, with higher scores indicating more physical problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
| Child Behavior Checklist: CBCL Sleep Composite | Parent Measure. The Sleep Health Composite Risk Score was assessed with a composite score of sleep from Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's sleep health. The CBCL sleep subscale is composed of 7-items CBCL items on a scale of 0-2, the range of scores is 0-14, with higher scores indicating more sleep problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
| Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups |
| Actigraphy Measured Total Sleep Time | calculated separately for weeknights and weekend nights to also compute the discrepancy between weeknights and weekend nights | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Total Wake Time (TWT) | Actigraphy Measured Sleep Onset Latency (SOL; calculated separately for weeknights and weekend nights) and Wake After Sleep Onset (WASO; calculated separately for weeknights and weekend nights) to create Total Wake Time (SOL+WASO) for weeknights, weekends and to also compute the discrepancy between weeknights and weekend nights | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Actigraphy Measured Daytime Activity Count | calculated separately for weekdays and weekends | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Daily Sleep Diary | total sleep time (weekend nights), weekend night bedtime, weekend rise time, total wake time (SOL+WASO) weeknights, total wake time (SOL+WASO) weekend nights, naps. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups |
| "Problems That Are Related to Romantic Relations" Subscale of the Problem Questionnaire | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Internet Behavior Checklist Questionnaire | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Rosenberg Self Esteem Scale Questionnaire | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Rosenberg Self Efficacy Scale Questionnaire | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Sleep Inertia Questionnaire | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Inventory of Parent and Peer Attachment Questionnaire | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Social Skills Rating Scale Questionnaire | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Estradiol Hormone Levels | from females only | Baseline only |
| Dehydroepiandrosterone (DHEA) Hormone Levels | collected via saliva sample DNA by saliva sample to examine selected circadian and emotion single nucleotide polymorphism (SNP) | Baseline only |
| Testosterone Hormone Levels | collected via saliva sample | Baseline only |
| Cytokines: Interleukin-6, Tumor Necrosis Factor-α, and C-reactive Protein. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Weight (Lbs) | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups |
| Height (Feet, Inches) | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups |
| Waist Circumference (cm) | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups |
| Hip Circumference (cm) | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups |
| Therapy Process Measure | Credibility Expectancy Questionnaire | Session 2 only |
| Emotion "GoNoGo" Task | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Emotional International Affective Pictures System (IAPS) Task | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Forward and Backward Digit Span | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Dimensional Card Sorting Task | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Food Desire Task and Snack Task (Only a Subsample of Participants) | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Face Naming Encoding Task (Only a Subsample of Participants) | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Face Naming Retrieval Task (Only a Subsample of Participants) | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Flanker Task (Only a Subsample of Participants) | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Children's Affective Lability Scale | Parent measure | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups |
| Problems in School Questionnaire | Parent measure | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| Parental Monitoring Questionnaire | Parent measure | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
| 31246052 | Derived | Dong L, Gumport NB, Martinez AJ, Harvey AG. Is improving sleep and circadian problems in adolescence a pathway to improved health? A mediation analysis. J Consult Clin Psychol. 2019 Sep;87(9):757-771. doi: 10.1037/ccp0000423. Epub 2019 Jun 27. |
| 30274649 | Derived | Harvey AG, Hein K, Dolsen EA, Dong L, Rabe-Hesketh S, Gumport NB, Kanady J, Wyatt JK, Hinshaw SP, Silk JS, Smith RL, Thompson MA, Zannone N, Blum DJ. Modifying the Impact of Eveningness Chronotype ("Night-Owls") in Youth: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2018 Oct;57(10):742-754. doi: 10.1016/j.jaac.2018.04.020. Epub 2018 Aug 15. |
Psychoeducation on the inter-associations between sleep, diet, exercise and stress.
Psychoeducation
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Youth aged 10 to 18 years with an evening chronotype and who were"at risk"in 1 of 5 health domains. Participants included 176 youth recruited through clinicians or advertisements. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education Level (at baseline) | Count of Participants | Participants |
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| Family annual income ($) | Count of Participants | Participants |
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| Any current K-SADS Diagnosis (teen report) | K-SADS = Schedule for Affective Disorders and Schizophrenia for School-Age Children. The K-SADS was administered separately to youth and one parent/caregiver to assess for participant current and lifetime Axis I disorders at the pretreatment assessment. | The number analyzed includes only those with data on this variable. | Count of Participants | Participants |
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| Any past K-SADS Diagnosis (teen report) | K-SADS = Schedule for Affective Disorders and Schizophrenia for School-Age Children. The K-SADS was administered separately to youth and one parent/caregiver to assess for participant current and lifetime Axis I disorders at the pretreatment assessment. | The number analyzed includes only those with data on this variable. | Count of Participants | Participants |
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| Any current K-SADS Diagnosis (parent report) | K-SADS = Schedule for Affective Disorders and Schizophrenia for School-Age Children. The K-SADS was administered separately to youth and one parent/caregiver to assess for participant current and lifetime Axis I disorders at the pretreatment assessment. | The number analyzed includes only those with data on this variable. | Count of Participants | Participants |
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| Any past K-SADS Diagnosis (parent report) | K-SADS = Schedule for Affective Disorders and Schizophrenia for School-Age Children. The K-SADS was administered separately to youth and one parent/caregiver to assess for participant current and lifetime Axis I disorders at the pretreatment assessment. | The number analyzed includes only those with data on this variable. | Count of Participants | Participants |
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| Primary | Average Bedtime on Weeknights Measured Via Daily Sleep Diary | Change in average bedtime on weeknights from pre-treatment to post-treatment measured via Daily Sleep Diary. 24-hour decimal format, where times after midnight are expressed as numbers above 24 (ex. 1:30 am is 25.50). The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | hours | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
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| Primary | Morning Eveningness Preference Measured Via Childrens Morningness Eveningness Preference Scale | Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale(CMEP). Scores range from 10 (Extreme evening preference) to 43 (Extreme morning preference). The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
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| Primary | Composite Score for Cognitive Domain | Cognitive composite score reflects cognitive functioning and was calculated by averaging the standardized summary scores from two measures: Attentional Control Scale (ACS) and Youth Social Adjustment Scale-Self Report (YSAS). Summary scores were calculated as 1.)ACS = sum of 20 items rated 1- 4; range: 20-80. Higher scores indicate less attentional control; and 2.) YSAS = sum of 6 school/cognitive-related items rated 1-5; range: 6-30. Higher scores indicate worse school-related impairment. Per participant, summary scores from the ACS and YSAS were computed and then standardized. The final composite (range -2.12 to 2.39) was calculated as the mean of the two standardized scores. Higher scores indicate greater attentional difficulty and school impairment. Change in this composite score from baseline to post treatment is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
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| Primary | Composite Score for Behavioral Domain | To assess functioning in the Behavioral domain, a Youth Self-Report Composite Risk Score is calculated by taking the mean of standardized summary scores from two measures: Sensation Seeking Scale for Children (SSS) and the Alcohol and Substance Use-Past 30 days (SU; items include questions on caffeine and energy drinks). Summary scores were calculated as 1.) SSS = sum of 8 items, rated 1-5, range: 8-40. Higher scores = greater sensation seeking; and 2.) SU = Sum of 23 items rated 0-7, range 0-161. Higher scores = more frequent use. For each participant, summary scores from the SSS and SU subscales were computed and standardized. The final composite (range -1.73 to 3.34) was calculated as the mean of the two standardized scores. Higher composite scores indicate higher impairment Change in this composite score from baseline to post-treatment is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
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| Primary | Composite Score for Emotional Domain | Youth Self-Report Composite Score, Emotional functioning domain is calculated by taking the mean of standardized summary scores from two measures: Children's Depression Rating Scale-Revised (CDRS) and the Multidimensional Anxiety Scale for Children (MASC). Summary scores were calculated as 1.) CDRS = Sum of 17 items. range 17-113. Higher scores indicate greater depressive symptoms; and 2.) MASC= Sum of 39 items. range 0-117. Higher scores indicate greater anxiety. For each participant, summary scores from the CDRS and MASC subscales were first computed and then standardized. The final composite (range -2.10 to 3.60) was calculated as the mean of the two standardized scores from the CDRS and MASC. Higher composite scores indicate greater emotional risk (i.e., more depression and anxiety symptoms). Change in this composite score from baseline to post treatment is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
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| Primary | Composite Score for Social Domain | Composite Score for Social Domain to assess functioning in the Social domain. Calculated by taking the average of the three subscales (ie, friends, family, romantic relationships) from the Youth Social Adjustment Scale - Self Report. Youth Social Adjustment Scale - social items only. 9 items (questions 7-15 out of the 23 item scale), item range 1-5. Summary score is calculated by taking the sum of all 9 items. no reverse coding needed. Summary score range 9-45. Higher score = more impaired adjustment. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | Composite score | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
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| Primary | Composite Score for Physical Domain | Composite Score for Physical Domain (physical functioning) is calculated by taking the mean of standardized summary scores from two measures: Modifiable Activity Questionnaire for Adolescents (MAQ) and Physical Health Questionnaire (PHQ). Summary scores were calculated as 1.) MAQ = sum of the number of hours per week not active/exercising. Higher scores indicate greater numbers of leisure hours; and 2. PHQ-15 = sum of item (13 items for males, 14 items for females), range 0-30. Higher scores indicate worse somatic complaints. For each participant, summary scores from the MAQ and PHQ-15 subscales were first computed and then standardized. The final composite (range -3.95 to 1.86) was calculated as the mean of the two standardized scores. Higher composite scores indicate greater physical health risk. Change in this composite score from baseline to post treatment is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
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| Secondary | Sleepiness Scale | Sleepiness subscale from School Sleep Habits Survey (SSHB). This subscale includes 10 items rated on a 4-point scale (0 - 3), assessing sleepiness. Total scores were calculated by summing all item responses. Possible scores range from 0 to 30, with higher scores indicating greater daytime sleepiness. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups |
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| Secondary | Dim Light Melatonin Onset | Melatonin levels were measured using 13 saliva samples collected at 30-minute intervals, beginning 5.5 hours before and ending 30 minutes after each participant's average bedtime (computed from 7 nights of sleep diary). For each timepoint (baseline and post-treatment), the dim light melatonin onset (DLMO) was estimated by identifying when melatonin levels crossed the 3.0 pg/ml threshold (i.e., the interpolated time). Change in the interpolated DLMO times from baseline to post treatment (which is an average of 9 weeks after the beginning of treatment) reported. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | hours | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
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| Secondary | Pittsburgh Sleep Quality Index | Pittsburgh Sleep Quality Index (PSQI). Summary score is calculated by taking the sum of item-level scores. Summary score range 0-21. A higher score means increased severity of difficulty in all sleep area components. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
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| Secondary | Discrepancy Between Weeknights and Weekends for Total Sleep Time | The discrepancy between weeknights and weekends for Total Sleep Time(TST). The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | Minutes | Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment. |
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| Secondary | Composite Risk Score of Functioning in Five Health-relevant Domains: Emotional Health (Positivity Ratio) | Composite Risk Score of Functioning in Emotional Health, measured via Ecological Momentary Assessment (EMA), assesses subjective emotional well-being across 7-days, per timepoint using a 9-item short form of the Positive and Negative Affect Scale for Children (PANAS-C), which included 4 positive affect items (min = 4, max = 20; higher scores indicate more positive affect) and 5 negative affect items (min = 5, max = 25; higher scores indicate more negative affect), each rated on a 5-point Likert scale. A positivity ratio was calculated by dividing the sum of each affect item scores by the sum of negative affect score per survey day. Higher positivity ratios (range: 0.16-4) indicate higher subjective well-being and less risk. Change in average Positivity Ratio from baseline to post treatment (which is an average of 9 weeks after the beginning of treatment) reported. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | ratio | Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment. |
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| Secondary | Child Behavior Checklist: Parent-report Emotional Health Composite Risk Score | Parent Measure. The Emotional Health Composite Risk Score was assessed with a composite score of the Anxious/Depressed and Withdrawn/Depressed subscales of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's emotional health, including items related to anxiety/depression. Range for composite total: 0-42, with higher scores indicating more problems. The CBCL Anxious/Depressed subscale is composed of 13-items CBCL items on a scale of 0-2, the range of scores is 0-26, with higher scores indicating more emotional problems. The CBCL Withdrawn/Depressed subscale is composed of 8-items CBCL items on a scale of 0-2, the range of scores is 0-16, with higher scores indicating more emotional problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition | Posted | Mean | 95% Confidence Interval | Composite score | Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment. |
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| Secondary | Discrepancy Between Weeknights and Weekends for Bedtime Via Daily Sleep Diary | The discrepancy between weeknights and weekends for Bedtime(BT) via Daily Sleep Diary. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | Minutes | Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment. |
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| Secondary | Discrepancy Between Weeknights and Weekends for Wake Time Via Daily Sleep Diary | The discrepancy between weeknights and weekends for Wake time (WUP) via Daily Sleep Diary. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | Minutes | Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment. |
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| Secondary | Composite Risk Score of Functioning in Five Health-relevant Domains: Cognitive Health | Composite Risk Score of Functioning in Cognitive Health measured via Ecological Momentary Assessment. Participants responded to 11 items that measured their concentration, distractedness, and focus related to their current activity. All items were rated on 5-point Likert scale, where higher scores respectively indicated higher levels of concentration, distractedness, and focus (min = 11, max = 55). The composite risk score was calculated by averaging participant responses over the assessment week. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | Composite score | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
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| Secondary | Composite Risk Score of Functioning in Five Health-relevant Domains: Behavioral Health | Composite Risk Score of Functioning in Behavioral Health measured via Ecological Momentary Assessment was assessed by directly asking participants about eating, drinking, chewing gum, and smoking behavior at the time the phone rang through 6 open-ended EMA questions. Responses were coded. The average weekly frequency of intake of junk food, caffeine, alcohol, nicotine, and other substances was tabulated. The minimum score was 0, and there was no maximum score. Higher scores indicate more risky behaviors and thus more risk. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | Composite score | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
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| Secondary | Composite Risk Score of Functioning in Five Health-relevant Domains: Physical Health | Composite Risk Score of Functioning in Physical Health derived from Ecological Momentary Assessment (EMA). For the physical health domain, responses to a single daily item (e.g., "Were you physically active today?") were used to create a binary score: 1 = active, 2 = inactive. Daily responses were collected over 7 days and both summed (range: 7-14) and averaged for each participant. The final composite score reflects the average of these daily values (range: 1 - 2) , where lower scores indicate greater physical activity and lower physical health risk. Change in this composite score from baseline to post treatment (which is an average of 9 weeks after the beginning of treatment) is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
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| Secondary | Composite Risk Score of Functioning in Five Health-relevant Domains: Social Health | Composite Risk Score of Functioning in Social health measured via Ecological Momentary Assessment was assessed by directly asking participants who the participant was with at the time the phone rang. Participants' responses were then manually coded for companion type on a scale of 0-4. Participants' positivity ratios, as calculated in the Emotional Health (Positivity Ratio) Composite Risk Score of Functioning, were then grouped based on occasions when participants were alone vs. with a family member vs. with a friend vs. other. Positivity ratios within groups were averaged (min = 0.16, max = 4), where higher averages indicated higher subjective well-being and lower risk. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | Composite score | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment |
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| Secondary | Child Behavior Checklist: Parent-report Cognitive Health Composite Risk Score | Parent Measure. Cognitive Health Composite Risk Score was assessed with the Thought Problems and Attention Problems subscale of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's cognitive health, including items related to thought problems. Range for composite total: 0-50, with higher scores indicating more cognitive problems. The CBCL Thought Problems subscale is composed of 15-items CBCL items on a scale of 0-2, the range of scores is 0-30, with higher scores indicating more problems. The CBCL Attention Problems subscale is composed of 10-items CBCL items on a scale of 0-2, the range of scores is 0-20, with higher scores indicating more problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition | Posted | Mean | 95% Confidence Interval | Composite score | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
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| Secondary | Child Behavior Checklist: Parent-report Behavioral Health Composite Risk Score | Parent Measure. The Behavioral Health Composite Risk Score was assessed with a composite score of the Rule-Breaking Behavior and Aggressive Behavior subscales of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's behavioral health, including items related to rule-breaking. Range for composite total: 0-70, with higher scores indicating more behavioral problems. The CBCL Rule-Breaking Behavior subscale is composed of 17-items CBCL items on a scale of 0-2, the range of scores is 0-34, with higher scores indicating more rule-breaking behavior. The CBCL Aggressive Behavior subscale is composed of 18-items CBCL items on a scale of 0-2, the range of scores is 0-36, with higher scores indicating more aggressive behavior. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | Composite score | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
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| Secondary | Child Behavior Checklist: Parent-report Social Health Composite Risk Score | Parent Measure. The Social Health Composite Risk Score was assessed with a composite score of the Social Problems subscale of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's social health. The CBCL Social Problems subscale is composed of 11-items CBCL items on a scale of 0-2, the range of scores is 0-22, with higher scores indicating more Social problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | Composite score | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
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| Secondary | Child Behavior Checklist: Parent-report Physical Health Composite Risk Score | Parent Measure. The Physical Health Composite Risk Score was assessed with a composite score of the Somatic Complaints subscale of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's Physical health (e.g., "vomiting"). The CBCL Somatic Complaints subscale is composed of 11-items CBCL items on a scale of 0-2, the range of scores is 0-22, with higher scores indicating more physical problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | Composite score | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
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| Secondary | Child Behavior Checklist: CBCL Sleep Composite | Parent Measure. The Sleep Health Composite Risk Score was assessed with a composite score of sleep from Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's sleep health. The CBCL sleep subscale is composed of 7-items CBCL items on a scale of 0-2, the range of scores is 0-14, with higher scores indicating more sleep problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. | Posted | Mean | 95% Confidence Interval | Composite score | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. |
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| Other Pre-specified | Diagnosis of Psychiatric Disorders | Measured via Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS) Interview | Not Posted | Baseline only | Participants |
| Other Pre-specified | Diagnosis of Sleep Disorders | Measured via Duke Structured Interview for Sleep Disorders | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups | Participants |
| Other Pre-specified | Actigraphy Measured Total Sleep Time | calculated separately for weeknights and weekend nights to also compute the discrepancy between weeknights and weekend nights | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Total Wake Time (TWT) | Actigraphy Measured Sleep Onset Latency (SOL; calculated separately for weeknights and weekend nights) and Wake After Sleep Onset (WASO; calculated separately for weeknights and weekend nights) to create Total Wake Time (SOL+WASO) for weeknights, weekends and to also compute the discrepancy between weeknights and weekend nights | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Actigraphy Measured Daytime Activity Count | calculated separately for weekdays and weekends | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Daily Sleep Diary | total sleep time (weekend nights), weekend night bedtime, weekend rise time, total wake time (SOL+WASO) weeknights, total wake time (SOL+WASO) weekend nights, naps. | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups | Participants |
| Other Pre-specified | "Problems That Are Related to Romantic Relations" Subscale of the Problem Questionnaire | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Internet Behavior Checklist Questionnaire | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Rosenberg Self Esteem Scale Questionnaire | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Rosenberg Self Efficacy Scale Questionnaire | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Sleep Inertia Questionnaire | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Inventory of Parent and Peer Attachment Questionnaire | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Social Skills Rating Scale Questionnaire | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Estradiol Hormone Levels | from females only | Not Posted | Baseline only | Participants |
| Other Pre-specified | Dehydroepiandrosterone (DHEA) Hormone Levels | collected via saliva sample DNA by saliva sample to examine selected circadian and emotion single nucleotide polymorphism (SNP) | Not Posted | Baseline only | Participants |
| Other Pre-specified | Testosterone Hormone Levels | collected via saliva sample | Not Posted | Baseline only | Participants |
| Other Pre-specified | Cytokines: Interleukin-6, Tumor Necrosis Factor-α, and C-reactive Protein. | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Weight (Lbs) | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups | Participants |
| Other Pre-specified | Height (Feet, Inches) | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups | Participants |
| Other Pre-specified | Waist Circumference (cm) | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups | Participants |
| Other Pre-specified | Hip Circumference (cm) | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups | Participants |
| Other Pre-specified | Therapy Process Measure | Credibility Expectancy Questionnaire | Not Posted | Session 2 only | Participants |
| Other Pre-specified | Emotion "GoNoGo" Task | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Emotional International Affective Pictures System (IAPS) Task | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Forward and Backward Digit Span | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Dimensional Card Sorting Task | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Food Desire Task and Snack Task (Only a Subsample of Participants) | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Face Naming Encoding Task (Only a Subsample of Participants) | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Face Naming Retrieval Task (Only a Subsample of Participants) | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Flanker Task (Only a Subsample of Participants) | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Children's Affective Lability Scale | Parent measure | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups | Participants |
| Other Pre-specified | Problems in School Questionnaire | Parent measure | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| Other Pre-specified | Parental Monitoring Questionnaire | Parent measure | Not Posted | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Participants |
| 0 |
| 89 |
| 0 |
| 89 |
| 0 |
| 89 |
| EG001 | Psychoeducation | Psychoeducation on the inter-associations between sleep, diet, exercise and stress. Psychoeducation | 0 | 87 | 0 | 87 | 0 | 87 |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Grade 7 |
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| Grade 8 |
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| Grade 9 |
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| Grade 10 |
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| Grade 11 |
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| Grade 12 |
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| College |
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| 50,001 - 100,000 |
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| 100,000+ |
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| Refused to answer/missing |
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| Social health: With a peer |
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Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: "With a family member" |
| intent-to-treat, multilevel modeling |
| 0.43 |
Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes. |
| d (effect size) |
| -0.18 |
| 2-Sided |
| Superiority |
| Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: "With a peer" | intent-to-treat, multilevel modeling | 0.37 | Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes. | d (effect size) | 0.21 | 2-Sided | Superiority |