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This pilot study will: (1) develop Sleeping Healthy/Living Healthy, a school-based health center (SBHC) intervention that combines MBIH and sleep hygiene strategies to improve sleep quality in urban adolescents with poor sleep quality; (2) evaluate the feasibility and acceptability of intervention procedures; and (3) assess the preliminary intervention effects on sleep quality in urban adolescents.
This study includes a development phase and a pilot individually-randomized group treatment (IRGT) phase. In Year 1, the investigators will develop the novel integrated intervention using an iterative participatory design process. In Year 2, the investigators will conduct an IRGT trial with 60 adolescents with insufficient sleep recruited from two SBHCs in New York City. Adolescents will be randomized 1:1 to receive the intervention or an attention control of equal intensity and duration. Process evaluation interviews guided by a rigorous fidelity framework with adolescents and with SBHC providers and personnel will be conducted to obtain feedback regarding intervention procedures.
Poor sleep quality, which contributes to impaired functioning, is elevated in urban, ethnic/racial minority adolescents due, in part, to poor sleep hygiene. Despite successful sleep hygiene interventions in younger children, none focus on adolescents, a group with unique developmental needs. Urban adolescents face unique contextual stressors, which may contribute to ineffective use of sleep hygiene behaviors. Mind-body integrative (MBIH) approaches (e.g. yoga, meditation) improve sleep quality in adults, but are rarely applied to adolescents. MBIH has been shown to reduce stress among adolescents. Taken together, this suggests that integrating MBIH with sleep hygiene strategies has the potential for a synergistic effect on improving sleep quality, yet no interventions concurrently use MBIH and sleep hygiene with adolescents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Sleeping Healthy/Living Healthy |
|
| Control | Active Comparator | Attention Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleeping Healthy/Living Healthy | Behavioral | Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Sleep Duration (Past 2 Weeks) | Measured using actigraphy. Measured in minutes. | Baseline (Day 0) |
| Average Sleep Duration (Past 2 Weeks) | Measured with actigraphy. Measured in minutes. | Immediate Post (up to 7 weeks after baseline) |
| Average Sleep Duration (Past 2 Weeks) | Measured in actigraphy. Measured in minutes. | Follow-up (up to 2.5 months) |
| Sleep Fragmentation - Sleep Efficiency (%) (Past Month) | Represented as a percentage. Sleep efficiency = (# hours slept/# hours in bed) X 100% Sleep efficiency can range from 0-100%, with higher sleep efficiency representing better sleep. The numerator and denominator will be measured through actigraphy. | Baseline (Day 0) |
| Sleep Fragmentation - Sleep Efficiency (%) (Past Month) | Represented as a percentage. Sleep efficiency = (# hours slept/# hours in bed) X 100% Sleep efficiency can range from 0-100%, with higher sleep efficiency representing better sleep. The numerator and denominator will be measured through actigraphy. | Immediate Post (up to 7 weeks after baseline) |
| Sleep Fragmentation - Sleep Efficiency (%) (Past Month) | Represented as a percentage. Sleep efficiency = (# hours slept/# hours in bed) X 100% Sleep efficiency can range from 0-100%, with higher sleep efficiency representing better sleep. The numerator and denominator will be measured through actigraphy. | Follow-up (up to 2.5 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Score on Pittsburgh Sleep Quality Index (PSQI Global Score) | Subjective sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), which contains 19 self-rated questions. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samantha Garbers-Adams, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Attention Control Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects. In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention. |
| FG001 | Intervention | Sleeping Healthy/Living Healthy Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Attention Control Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects. In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention. |
| 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, Customized | Number |
| 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 | Average Sleep Duration (Past 2 Weeks) | Measured using actigraphy. Measured in minutes. | Only 27 out of 30 Control and 27 out of 31 Intervention participants completed the actigraphy and were included in the analysis. | Posted | Mean | Standard Deviation | minutes | Baseline (Day 0) |
|
Up to 2.5 months
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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 | Intervention | Sleeping Healthy/Living Healthy Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samantha Garbers-Adams, PhD | Columbia University Irving Medical Center | 212-305-0123 | svg2108@cumc.columbia.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 | Nov 19, 2021 | Jun 16, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
| Attention Control | Behavioral | The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects. In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention. |
|
| Sleep Fragmentation - Number of Sleep Disruptions (Past Month) | Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy. | Baseline (Day 0) |
| Sleep Fragmentation - Number of Sleep Disruptions (Past Month) | Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy. | Immediate Post (up to 7 weeks after baseline) |
| Sleep Fragmentation - Number of Sleep Disruptions (Past Month) | Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy. | Follow-up (up to 2.5 months) |
| Baseline (Day 0) |
| Score on Pittsburgh Sleep Quality Index (PSQI Global Score) | Subjective sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), which contains 19 self-rated questions. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. | Immediate Post (up to 7 weeks after baseline) |
| Score on Pittsburgh Sleep Quality Index (PSQI Global Score) | Subjective sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), which contains 19 self-rated questions. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. | Follow-up (up to 2.5 months) |
| Score on the Perceived Stress Scale (PSS) | Stress will be measured using Perceived Stress Scale (past month). The PSS has 10 items, completed using self-report. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress; scores ranging from 14-26 would be considered moderate stress; scores ranging from 27-40 would be considered high perceived stress. | Baseline (Day 0) |
| Score on the Perceived Stress Scale (PSS) | Stress will be measured using Perceived Stress Scale (past month). The PSS has 10 items, completed using self-report. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress; scores ranging from 14-26 would be considered moderate stress; scores ranging from 27-40 would be considered high perceived stress. | Immediate Post (up to 7 weeks after baseline) |
| Score on the Perceived Stress Scale (PSS) | Stress will be measured using Perceived Stress Scale (past month). The PSS has 10 items, completed using self-report. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress; scores ranging from 14-26 would be considered moderate stress; scores ranging from 27-40 would be considered high perceived stress. | Follow-up (up to 2.5 months) |
| Score on the PROMIS Psychological Stress Experiences Survey - T Score | Stress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experiences Ped Short Form (SF) v1.0 (past 7 days), an 8-item self report. For PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Psychological Stress Experiences, a T-score of 60 is one standard deviation (SD) worse than average. | Baseline (Day 0) |
| Score on the PROMIS Psychological Stress Experiences Survey - T Score | Stress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experiences Ped Short Form (SF) v1.0 (past 7 days), an 8-item self report. For PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Psychological Stress Experiences, a T-score of 60 is one standard deviation (SD) worse than average. | Immediate Post (up to 7 weeks after baseline) |
| Score on the PROMIS Psychological Stress Experiences Survey - T Score | Stress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experiences Ped Short Form (SF) v1.0 (past 7 days), an 8-item self report. For PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Psychological Stress Experiences, a T-score of 60 is one standard deviation (SD) worse than average. | Follow-up (up to 2.5 months) |
| Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T-Score | Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety Short Form 8a v2.0, an 8-item questionnaire assessing self-reported fear, anxious misery, and hyperarousal. Using a five-point frequency scale, ranging from 1 (never) to 5 (almost always), adolescents indicate how frequently or infrequently they felt various dimensions of anxiety (e.g., nervous, scared, worried) in the past 7 days. PROMIS instruments are scored using item-level calibrations. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Anxiety, a T-score of 60 is one standard deviation (SD) worse than average. | Baseline (Day 0) |
| Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score | Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety Short Form 8a v2.0, an 8-item questionnaire assessing self-reported fear, anxious misery, and hyperarousal. Using a five-point frequency scale, ranging from 1 (never) to 5 (almost always), adolescents indicate how frequently or infrequently they felt various dimensions of anxiety (e.g., nervous, scared, worried) in the past 7 days. PROMIS instruments are scored using item-level calibrations. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Anxiety, a T-score of 60 is one standard deviation (SD) worse than average. | Immediate Post (up to 7 weeks after baseline) |
| Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score | Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety Short Form 8a v2.0, an 8-item questionnaire assessing self-reported fear, anxious misery, and hyperarousal. Using a five-point frequency scale, ranging from 1 (never) to 5 (almost always), adolescents indicate how frequently or infrequently they felt various dimensions of anxiety (e.g., nervous, scared, worried) in the past 7 days. PROMIS instruments are scored using item-level calibrations. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Anxiety, a T-score of 60 is one standard deviation (SD) worse than average. | Follow-up (up to 2.5 months) |
| Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score | Subjective sleep-related impairment will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep-Related Impairment Short Form 8a v1.0, an 8-item questionnaire focusing on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Adolescents rate various aspects of their sleep over the past 7 days on a 5-point frequency scale ranging from 1 (never) to 5 (always). PROMIS instruments are scored using item-level calibrations. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Sleep-Related Impairment, a T-score of 60 is one standard deviation (SD) | Baseline (Day 0) |
| Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score | Subjective sleep-related impairment will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep-Related Impairment Short Form 8a v1.0, an 8-item questionnaire focusing on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Adolescents rate various aspects of their sleep over the past 7 days on a 5-point frequency scale ranging from 1 (never) to 5 (always). PROMIS instruments are scored using item-level calibrations. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Sleep-Related Impairment, a T-score of 60 is one standard deviation (SD) worse than average. | Immediate Post (up to 7 weeks after baseline) |
| Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score | Subjective sleep-related impairment will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep-Related Impairment Short Form 8a v1.0, an 8-item questionnaire focusing on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Adolescents rate various aspects of their sleep over the past 7 days on a 5-point frequency scale ranging from 1 (never) to 5 (always). PROMIS instruments are scored using item-level calibrations. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Sleep-Related Impairment, a T-score of 60 is one standard deviation (SD) worse than average. | Follow-up (up to 2.5 months) |
| Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents) | Mindfulness will be measured using the MAAS-A, a self-reported 14-item questionnaire that measures the level of mindfulness, defined as "a receptive state of attention that, informed by an awareness of present experience, simply observes what is taking place." The MAAS-A is an adapted adolescent version of the validated Mindful Attention Awareness Scale (MAAS), which was developed for use with adult populations and considers mindfulness to be a one-dimensional construct. Using a six-point scale, ranging from 1 (almost always) to 6 (almost never), adolescents indicate how frequently or infrequently they currently have each experience. The score is the mean of the 14 items with higher scores reflecting higher trait mindfulness. | Baseline (Day 0) |
| Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents) | Mindfulness will be measured using the MAAS-A, a self-reported 14-item questionnaire that measures the level of mindfulness, defined as "a receptive state of attention that, informed by an awareness of present experience, simply observes what is taking place." The MAAS-A is an adapted adolescent version of the validated Mindful Attention Awareness Scale (MAAS), which was developed for use with adult populations and considers mindfulness to be a one-dimensional construct. Using a six-point scale, ranging from 1 (almost always) to 6 (almost never), adolescents indicate how frequently or infrequently they currently have each experience. The score is the mean of the 14 items with higher scores reflecting higher trait mindfulness. | Immediate Post (up to 7 weeks after baseline) |
| Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents) | Mindfulness will be measured using the MAAS-A, a self-reported 14-item questionnaire that measures the level of mindfulness, defined as "a receptive state of attention that, informed by an awareness of present experience, simply observes what is taking place." The MAAS-A is an adapted adolescent version of the validated Mindful Attention Awareness Scale (MAAS), which was developed for use with adult populations and considers mindfulness to be a one-dimensional construct. Using a six-point scale, ranging from 1 (almost always) to 6 (almost never), adolescents indicate how frequently or infrequently they currently have each experience. The score is the mean of the 14 items with higher scores reflecting higher trait mindfulness. | Follow-up (up to 2.5 months) |
| BG001 | Intervention | Sleeping Healthy/Living Healthy Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | 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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| OG001 | Intervention | Sleeping Healthy/Living Healthy Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators. |
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| Primary | Average Sleep Duration (Past 2 Weeks) | Measured with actigraphy. Measured in minutes. | Only 18 out of 30 Control and 24 out of 31 Intervention participants completed the actigraphy and were included in the analysis. | Posted | Mean | Standard Deviation | minutes | Immediate Post (up to 7 weeks after baseline) |
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| Primary | Average Sleep Duration (Past 2 Weeks) | Measured in actigraphy. Measured in minutes. | Only 19 out of 30 Control and 18 out of 31 Intervention participants completed the actigraphy and were included in the analysis. | Posted | Mean | Standard Deviation | minutes | Follow-up (up to 2.5 months) |
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| Primary | Sleep Fragmentation - Sleep Efficiency (%) (Past Month) | Represented as a percentage. Sleep efficiency = (# hours slept/# hours in bed) X 100% Sleep efficiency can range from 0-100%, with higher sleep efficiency representing better sleep. The numerator and denominator will be measured through actigraphy. | Only 27 out of 30 Control and 27 out of 31 Intervention participants completed the actigraphy and were included in the analysis. | Posted | Mean | Standard Deviation | percentage of sleep efficiency | Baseline (Day 0) |
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| Primary | Sleep Fragmentation - Sleep Efficiency (%) (Past Month) | Represented as a percentage. Sleep efficiency = (# hours slept/# hours in bed) X 100% Sleep efficiency can range from 0-100%, with higher sleep efficiency representing better sleep. The numerator and denominator will be measured through actigraphy. | Only 18 out of 30 Control and 24 out of 31 Intervention participants completed the actigraphy and were included in the analysis. | Posted | Mean | Standard Deviation | percentage of sleep efficiency | Immediate Post (up to 7 weeks after baseline) |
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| Primary | Sleep Fragmentation - Sleep Efficiency (%) (Past Month) | Represented as a percentage. Sleep efficiency = (# hours slept/# hours in bed) X 100% Sleep efficiency can range from 0-100%, with higher sleep efficiency representing better sleep. The numerator and denominator will be measured through actigraphy. | Only 19 out of 30 Control and 18 out of 31 Intervention participants completed the actigraphy and were included in the analysis. | Posted | Mean | Standard Deviation | percentage of sleep efficiency | Follow-up (up to 2.5 months) |
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| Primary | Sleep Fragmentation - Number of Sleep Disruptions (Past Month) | Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy. | Only 27 out of 30 Control and 27 out of 31 Intervention participants completed the actigraphy and were included in the analysis. | Posted | Mean | Standard Deviation | number of times awakened | Baseline (Day 0) |
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| Primary | Sleep Fragmentation - Number of Sleep Disruptions (Past Month) | Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy. | Only 18 out of 30 Control and 24 out of 31 Intervention participants completed the actigraphy and were included in the analysis. | Posted | Mean | Standard Deviation | number of times awakened | Immediate Post (up to 7 weeks after baseline) |
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| Primary | Sleep Fragmentation - Number of Sleep Disruptions (Past Month) | Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy. | Only 19 out of 30 Control and 18 out of 31 Intervention participants completed the actigraphy and were included in the analysis. | Posted | Mean | Standard Deviation | number of times awakened | Follow-up (up to 2.5 months) |
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| Secondary | Score on Pittsburgh Sleep Quality Index (PSQI Global Score) | Subjective sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), which contains 19 self-rated questions. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. | Posted | Mean | Standard Error | global score on a scale | Baseline (Day 0) |
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| Secondary | Score on Pittsburgh Sleep Quality Index (PSQI Global Score) | Subjective sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), which contains 19 self-rated questions. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. | Posted | Mean | Standard Error | global score on a scale | Immediate Post (up to 7 weeks after baseline) |
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| Secondary | Score on Pittsburgh Sleep Quality Index (PSQI Global Score) | Subjective sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), which contains 19 self-rated questions. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. | Posted | Mean | Standard Error | global score on a scale | Follow-up (up to 2.5 months) |
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| Secondary | Score on the Perceived Stress Scale (PSS) | Stress will be measured using Perceived Stress Scale (past month). The PSS has 10 items, completed using self-report. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress; scores ranging from 14-26 would be considered moderate stress; scores ranging from 27-40 would be considered high perceived stress. | Posted | Mean | Standard Error | score on a scale | Baseline (Day 0) |
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| Secondary | Score on the Perceived Stress Scale (PSS) | Stress will be measured using Perceived Stress Scale (past month). The PSS has 10 items, completed using self-report. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress; scores ranging from 14-26 would be considered moderate stress; scores ranging from 27-40 would be considered high perceived stress. | Posted | Mean | Standard Error | score on a scale | Immediate Post (up to 7 weeks after baseline) |
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| Secondary | Score on the Perceived Stress Scale (PSS) | Stress will be measured using Perceived Stress Scale (past month). The PSS has 10 items, completed using self-report. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress; scores ranging from 14-26 would be considered moderate stress; scores ranging from 27-40 would be considered high perceived stress. | Posted | Mean | Standard Error | score on a scale | Follow-up (up to 2.5 months) |
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| Secondary | Score on the PROMIS Psychological Stress Experiences Survey - T Score | Stress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experiences Ped Short Form (SF) v1.0 (past 7 days), an 8-item self report. For PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Psychological Stress Experiences, a T-score of 60 is one standard deviation (SD) worse than average. | Posted | Mean | Standard Error | PROMIS T-score on a scale | Baseline (Day 0) |
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| Secondary | Score on the PROMIS Psychological Stress Experiences Survey - T Score | Stress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experiences Ped Short Form (SF) v1.0 (past 7 days), an 8-item self report. For PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Psychological Stress Experiences, a T-score of 60 is one standard deviation (SD) worse than average. | Posted | Mean | Standard Error | PROMIS T-score on a scale | Immediate Post (up to 7 weeks after baseline) |
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| Secondary | Score on the PROMIS Psychological Stress Experiences Survey - T Score | Stress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experiences Ped Short Form (SF) v1.0 (past 7 days), an 8-item self report. For PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Psychological Stress Experiences, a T-score of 60 is one standard deviation (SD) worse than average. | Posted | Mean | Standard Error | PROMIS T-score on a scale | Follow-up (up to 2.5 months) |
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| Secondary | Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T-Score | Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety Short Form 8a v2.0, an 8-item questionnaire assessing self-reported fear, anxious misery, and hyperarousal. Using a five-point frequency scale, ranging from 1 (never) to 5 (almost always), adolescents indicate how frequently or infrequently they felt various dimensions of anxiety (e.g., nervous, scared, worried) in the past 7 days. PROMIS instruments are scored using item-level calibrations. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Anxiety, a T-score of 60 is one standard deviation (SD) worse than average. | Posted | Mean | Standard Error | PROMIS T-score on a scale | Baseline (Day 0) |
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| Secondary | Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score | Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety Short Form 8a v2.0, an 8-item questionnaire assessing self-reported fear, anxious misery, and hyperarousal. Using a five-point frequency scale, ranging from 1 (never) to 5 (almost always), adolescents indicate how frequently or infrequently they felt various dimensions of anxiety (e.g., nervous, scared, worried) in the past 7 days. PROMIS instruments are scored using item-level calibrations. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Anxiety, a T-score of 60 is one standard deviation (SD) worse than average. | Posted | Mean | Standard Error | PROMIS T-score on a scale | Immediate Post (up to 7 weeks after baseline) |
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| Secondary | Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score | Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety Short Form 8a v2.0, an 8-item questionnaire assessing self-reported fear, anxious misery, and hyperarousal. Using a five-point frequency scale, ranging from 1 (never) to 5 (almost always), adolescents indicate how frequently or infrequently they felt various dimensions of anxiety (e.g., nervous, scared, worried) in the past 7 days. PROMIS instruments are scored using item-level calibrations. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Anxiety, a T-score of 60 is one standard deviation (SD) worse than average. | Posted | Mean | Standard Error | PROMIS T-score on a scale | Follow-up (up to 2.5 months) |
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| Secondary | Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score | Subjective sleep-related impairment will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep-Related Impairment Short Form 8a v1.0, an 8-item questionnaire focusing on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Adolescents rate various aspects of their sleep over the past 7 days on a 5-point frequency scale ranging from 1 (never) to 5 (always). PROMIS instruments are scored using item-level calibrations. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Sleep-Related Impairment, a T-score of 60 is one standard deviation (SD) | Posted | Mean | Standard Error | PROMIS T-score on a scale | Baseline (Day 0) |
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| Secondary | Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score | Subjective sleep-related impairment will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep-Related Impairment Short Form 8a v1.0, an 8-item questionnaire focusing on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Adolescents rate various aspects of their sleep over the past 7 days on a 5-point frequency scale ranging from 1 (never) to 5 (always). PROMIS instruments are scored using item-level calibrations. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Sleep-Related Impairment, a T-score of 60 is one standard deviation (SD) worse than average. | Posted | Mean | Standard Error | PROMIS T-score on a scale | Immediate Post (up to 7 weeks after baseline) |
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| Secondary | Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score | Subjective sleep-related impairment will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep-Related Impairment Short Form 8a v1.0, an 8-item questionnaire focusing on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Adolescents rate various aspects of their sleep over the past 7 days on a 5-point frequency scale ranging from 1 (never) to 5 (always). PROMIS instruments are scored using item-level calibrations. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Sleep-Related Impairment, a T-score of 60 is one standard deviation (SD) worse than average. | Posted | Mean | Standard Error | PROMIS T-score on a scale | Follow-up (up to 2.5 months) |
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| Secondary | Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents) | Mindfulness will be measured using the MAAS-A, a self-reported 14-item questionnaire that measures the level of mindfulness, defined as "a receptive state of attention that, informed by an awareness of present experience, simply observes what is taking place." The MAAS-A is an adapted adolescent version of the validated Mindful Attention Awareness Scale (MAAS), which was developed for use with adult populations and considers mindfulness to be a one-dimensional construct. Using a six-point scale, ranging from 1 (almost always) to 6 (almost never), adolescents indicate how frequently or infrequently they currently have each experience. The score is the mean of the 14 items with higher scores reflecting higher trait mindfulness. | Posted | Mean | Standard Error | score on a scale | Baseline (Day 0) |
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| Secondary | Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents) | Mindfulness will be measured using the MAAS-A, a self-reported 14-item questionnaire that measures the level of mindfulness, defined as "a receptive state of attention that, informed by an awareness of present experience, simply observes what is taking place." The MAAS-A is an adapted adolescent version of the validated Mindful Attention Awareness Scale (MAAS), which was developed for use with adult populations and considers mindfulness to be a one-dimensional construct. Using a six-point scale, ranging from 1 (almost always) to 6 (almost never), adolescents indicate how frequently or infrequently they currently have each experience. The score is the mean of the 14 items with higher scores reflecting higher trait mindfulness. | Posted | Mean | Standard Error | score on a scale | Immediate Post (up to 7 weeks after baseline) |
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| Secondary | Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents) | Mindfulness will be measured using the MAAS-A, a self-reported 14-item questionnaire that measures the level of mindfulness, defined as "a receptive state of attention that, informed by an awareness of present experience, simply observes what is taking place." The MAAS-A is an adapted adolescent version of the validated Mindful Attention Awareness Scale (MAAS), which was developed for use with adult populations and considers mindfulness to be a one-dimensional construct. Using a six-point scale, ranging from 1 (almost always) to 6 (almost never), adolescents indicate how frequently or infrequently they currently have each experience. The score is the mean of the 14 items with higher scores reflecting higher trait mindfulness. | Posted | Mean | Standard Error | score on a scale | Follow-up (up to 2.5 months) |
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| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Control | Attention Control Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects. In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention. | 0 | 30 | 0 | 30 | 0 | 30 |
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