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| ID | Type | Description | Link |
|---|---|---|---|
| SL-2024C1-37532-IC | Other Identifier | PCORI |
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| Name | Class |
|---|---|
| Nationwide Children's Hospital | OTHER |
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The goal of this clinical trial is to conduct a comparative effectiveness trial that will evaluate two school-based interventions to improve adolescent sleep health: the standard Sleep Health Education (SHE) and a stepped care version of the Transdiagnostic Sleep and Circadian intervention (TS-C-STEP). The main questions it aims to answer [is/are]:
Researchers will compare sleep quality to determine which intervention is most effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Health Education (SHE) | Active Comparator | Participants will be given access to a program, developed for the proposed project, with American Academy of Sleep Medicine (AASM) videos, worksheets and sleep diaries aimed to improve sleep health. |
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| Transdiagnostic Sleep and Circadian intervention (TS-C-STEP | Experimental | In the TS-C-STEP condition, all participants initially are given access to the TS-C program. TS-C is an evidence based cognitive behavioral sleep intervention. Youth will be stepped up to higher levels of care dependent on their progress with the program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-C-STEP | Behavioral | Cognitive behavioral sleep intervention. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline for total score sleep quality using the Pittsburgh Sleep Quality Index. | A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The sum of scores yields one global score with a minimum score of 0 and a maximum score of 21. A higher score indicates more self-reported sleep problems. | Baseline to 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline for total insomnia severity score sleep health using the insomnia severity index. | 7-item scale assessing the perceived severity of insomnia symptoms. The sum of scores yields a total score with a minimum score of 0 and a maximum score of 28. A higher score indicates more severe insomnia symptoms. | Baseline to 14 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariam Adeyeba, PhD | Contact | 3233569224 | madeyeba@chla.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lauren Asarnow,, PhD | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Recruiting | Los Angeles | California | 90027 | United States |
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| Sleep Health Education (SHE) | Behavioral | Health Education |
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| Change from baseline for total evening circadian preference score sleep health using the Children's Morningness and Eveningness Preference. |
Evening Circadian Preference is a reliable and valid 10-item measure of circadian preference among youth |
| Baseline to 14 months |
| Change from baseline for total sleep related impairment score sleep health using the PROMIS sleep related impairment questionnaire. | PROMIS is a well-validated 8-item measure which assesses self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. A total raw score can range from 8 to 40, with a higher score indicating more sleep related impairment. | Baseline to 14 months |
| Change from baseline for sleep duration estimates from sleep diaries. | Sleep diary asks participants about daily morning estimates of sleep the night prior parameters yield a reliable and valid clinical index of self-reported sleep duration. | Baseline to 14 months |
| Change from baseline for quality of life and functioning using the PROMIS Global Health Questionnaire. | The PROMIS Scale Global Health is a ten-item patient reported measure of physical, mental and social health. | Baseline to 14 months |
| Change from baseline for academic functioning using official transcripts provided by participants. | Academic Functioning Youth participants will be asked to provider their official academic transcripts. | Baseline to 14 months |
| Change from baseline for overall mental health using your self-report (youth) | Youth Self-Report (YSR) is a widely used self-report measure that assesses problem behaviors across multiple domains and provides a summary of total problems which can range from 0 to 224 in raw scores; a higher score indicates more self-reported problems. Raw scores are converted to standardized T-scores, which are adjusted for age and gender and are used to compare a youth's score to a normative sample. | Baseline to 14 months |
| Change from baseline for overall mental health using child-behavior checklist (parent). | Child Behavior Checklist (CBCL) completed by parents is a widely used child-report measure that assesses problem behaviors across multiple domains and provides a summary of total problems which can range from 0 to 198 in raw scores; a higher score indicates more self-reported problems. Raw scores are converted to standardized T-scores, which are adjusted for age and gender and are used to compare a youth's score to a normative sample. | Baseline to 14 months |
| Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43205 | United States |
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