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 \[is/are\]: * TS-C-STEP will yield superior outcomes relative to SHE at post-treatment and up to 12 months following treatment. * In this large and diverse sample, vulnerable subgroups (e.g. socioeconomically disadvantaged, racial, ethnic, rural, and youth with comorbid learning and/or mental health conditions) will experience greater benefits from TS-C-STEP compared to SHE on primary and secondary outcomes. Researchers will compare sleep quality to determine which intervention is most effective.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,320
Cognitive behavioral sleep intervention.
Health Education
Children's Hospital Los Angeles
Los Angeles, California, United States
RECRUITINGNationwide Children's Hospital
Columbus, Ohio, United States
RECRUITINGChange 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.
Time frame: Baseline to 14 months
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.
Time frame: Baseline to 14 months
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 14 months
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