Comparing Two School-Based Sleep Health Interventions To Promote Sleep Quality in Youth
ConditionSleep
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorChildren's Hospital Los Angeles
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 12-18 years old
Sleep health problem (i.e. insomnia, evening circadian preference, short sleep duration, poor sleep quality)
Able to participate in a general education classroom.
Disqualifiers
Previous participation in the study;
Symptoms or illness that precludes informed consent or engagement in study procedures ; youth not fluent in English, parent not fluent in English, or Spanish.
Trial design
Design model
Crossover
Treatments tested in this trial
TS-C-STEP
BehavioralCognitive behavioral sleep intervention.
Sleep Health Education (SHE)
BehavioralHealth Education
Treatment groups
1,320 Participants
are divided into 2 treatment groupsGroup A: Sleep Health Education (SHE)Active comparator 1 intervention
Group B: Transdiagnostic Sleep and Circadian intervention (TS-C-STEPExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to 14 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital Los Angeles
Lead sponsor
Nationwide Children's Hospital
Collaborator
Source ClinicalTrials.gov