School-Based Interventions for Sleep

Not yet recruiting at 1 trial location

Overseen By Mariam Adeyeba, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Disqualifiers: Previous participation, Language barrier, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to improve sleep in teenagers by comparing two different school-based programs. One program, Sleep Health Education (SHE), uses videos and worksheets to teach better sleep habits. The other, TS-C-STEP, adapts to each teen's progress, offering a more flexible approach. The trial focuses on helping teens with sleep problems who also face challenges like low income or mental health issues. Teens aged 12-18 who struggle with sleep issues such as insomnia or short sleep are well-suited for this trial. As an unphased trial, this study offers a unique opportunity for teens to contribute to research that could enhance sleep health education in schools.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that sleep education programs like Sleep Health Education (SHE) are safe for children and teens. These programs use videos and worksheets to teach better sleep habits, with no reports of serious side effects.

Research has shown that the Transdiagnostic Sleep and Circadian intervention (TS-C-STEP) is also safe. This program addresses sleep problems and can be tailored to individual needs, with studies reporting no serious issues.

Both treatments aim to improve sleep without medication, making them generally easy to tolerate. No evidence of harmful effects exists, so they are considered safe options for improving sleep in adolescents. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for improving sleep health in schools because they offer unique approaches to tackling sleep issues among youth. The Sleep Health Education (SHE) program gives students access to engaging materials from the American Academy of Sleep Medicine, like videos and worksheets, making learning about healthy sleep habits interactive and fun. Meanwhile, the Transdiagnostic Sleep and Circadian intervention (TS-C-STEP) stands out by using a personalized cognitive-behavioral approach, which steps up the level of care based on individual progress. This adaptability caters specifically to each participant's needs, potentially offering more effective results than traditional one-size-fits-all methods.

What evidence suggests that this trial's treatments could be effective for improving adolescent sleep health?

In this trial, participants will be assigned to one of two treatment arms. Research has shown that the Sleep Health Education (SHE) program, which participants in one arm will receive, can help teenagers learn about sleep and slightly improve their sleep habits and quality. One study found that participants slept longer on weekends after 5 and 10 weeks. However, some studies suggest these programs might not always lead to major improvements in sleep health.

In contrast, participants in the other arm will receive the Transdiagnostic Sleep and Circadian intervention (TS-C-STEP), which has shown better results. It significantly improved sleep quality, reduced insomnia, and boosted overall well-being. Additionally, TS-C-STEP has been linked to fewer sleep problems and less trouble during the day. These findings suggest that TS-C-STEP may be more effective than SHE for improving sleep in teenagers. ^{1 4 6 7 8}

Who Is on the Research Team?

Lauren Asarnow,, PhD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for young people who are looking to improve their sleep quality. It's especially focused on helping those from diverse backgrounds, including those facing socioeconomic challenges or with learning and mental health conditions.

Inclusion Criteria

I am between 12 and 18 years old.

I have problems with my sleep, like insomnia or poor sleep quality.

I can take part in regular school classes.

Exclusion Criteria

Previous participation in the study

Symptoms or illness that preclude informed consent or engagement in study procedures

I, or my parent, do not speak English or Spanish fluently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Sleep Health Education (SHE) or the Transdiagnostic Sleep and Circadian intervention (TS-C-STEP) to improve sleep health

12 months

Follow-up

Participants are monitored for sleep quality, insomnia severity, circadian preference, academic functioning, sleep-related impairment, quality of life, and mental health

2 months

What Are the Treatments Tested in This Trial?

Interventions

• SHE
• TS-C-STEP

Trial Overview Researchers are testing two school-based programs: a standard Sleep Health Education (SHE) and an advanced Transdiagnostic Sleep and Circadian intervention (TS-C-STEP). They want to see which one helps teens sleep better immediately after treatment and up to a year later.

How Is the Trial Designed?

Group I: Transdiagnostic Sleep and Circadian intervention (TS-C-STEP Experimental Treatment 1 Intervention

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.

Group II: Sleep Health Education (SHE) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

Nationwide Children's Hospital

Collaborator

Trials

354

Recruited

5,228,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10996385/

Sleep behavioral outcomes of school-based interventions ... School-based interventions have the potential to improve child sleep health. Sleep education interventions have commonly been trialed but have ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590142719300114

The Teensleep study: the effectiveness of a school-based ... Large improvements in sleep knowledge (d = 0.78), and smaller improvements in sleep quality (d = 0.15) and sleep hygiene (d = 0.11) were observed, but not in ...

3. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.3874

Sleep Education Improves the Sleep Duration of Adolescents Participants in the intervention group slept longer during weekend nights at 5 weeks (1:37 h:min, p = 0.01) and 10 weeks: (1:32 h:min, p = 0.03) compared to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2647787/

Evaluation of a School-Based Intervention for Adolescent ... Specifically, 60% reported a sleep onset latency > 30 min, and 35% reported excessive daytime sleepiness. More than half the sample (53%) reported insufficient ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/josh.70061

Process Evaluation of a School‐Based Intervention ... Despite the potential of school-based interventions, few have successfully improved adolescent sleep health. To enhance intervention ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1389945715006462

Can a school-based sleep education programme improve ... The present study investigated the effectiveness of a school-based sleep education programme in improving key sleep behaviours, sleep knowledge, and sleep ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2794639

Effects of a Sleep Health Education Program for Children ... The primary outcome, nighttime sleep duration, increased to clinically insignificant means of 5.6 minutes at 9 months (primary outcome) and 6.8 ...

8. ajmc.com ajmc.com/view/schoolbased-intervention-for-sleep-education-shown-to-benefit-adolescents-

School-Based Intervention for Sleep Education Shown to ... Data were collected before intervention and at a 1-year follow-up; the primary outcome was sleep duration, and secondary outcomes included ...