Sleep Treatment for Teens (RCT Phase) (NCT07303959)
Sleep Treatment for Teens
๐ฉบ Plain-English Summary (8th-Grade Level)
The purpose of this research study is to compare (vs. treatment as usual) a brief (6-session), empirically supported, and highly disseminable version of digital (i.e., smartphone or web-based) cognitive behavioral therapy for insomnia (dCBT-I), called SleepioTM, in suicidal adolescents with co-occurring insomnia during the high-risk post-hospitalization period. Suicide is the 2nd leading cause of death among adolescents. Sleep problems, such as insomnia symptoms-the most common sleep problem in youth-may be a particularly promising treatment target to reduce suicide risk in adolescents. The investigators propose to test the feasibility, acceptability, and effectiveness of dCBT-I in a two-site (Rutgers and Old Dominion University) pilot study trial. Adolescents, 14-18 years-old, recently hospitalized for suicide risk with co-occurring insomnia (n=80, 50% at each site), will receive either dCBT-I (six weekly, 20-minute sessions) plus post-hospitalization treatment-as-usual (TAU) or TAU alone. Adolescents will complete assessments pre-treatment, during the treatment phase including at the end of treatment, and 1-month follow-up post-treatment.
Who can join: Review the eligibility criteria below.
Location: Rutgers University Behavioral Healthcare โ Piscataway, New Jersey
Age range: 14 Years to 18 Years
๐งช Interventions in This Study
- Sleepio (BEHAVIORAL)
- Treatment as Usual (TAU) (BEHAVIORAL)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (2 Sites)
- Rutgers University Behavioral Healthcare โ Piscataway, New Jersey
- Children's Hospital of The King's Daughters โ Norfolk, Virginia
๐ Contact the Study Coordinator
Phone: (848) 445-2345
Email: evan.kleiman@rutgers.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Sleep Problems
- Good Nights Sleep Program to Improve Child and Family Sleep โ Auburn, Alabama
- The Impact of Melatonin Lotion on Sleep and Mental Health โ Redlands, California
- Generative AI for Sleep Promotion โ New York, New York
Explore by condition: All Sleep Problems clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.