Targeting Insomnia in School Aged Children With Autism Spectrum Disorder (NCT04545606)
🩺 Plain-English Summary (8th-Grade Level)
Children with Autism Spectrum Disorder (ASD) and insomnia, and their parent(s) will undergo 4 sessions of behavioral therapy for sleep problems followed by 4 bimonthly booster sessions. Children and their families will be randomly assigned to one of three conditions: cognitive behavioral therapy (in-person), cognitive behavioral therapy (remote), or behavioral therapy (remote). Arousal will be measured through heart-rate variability. Sleep and secondary outcomes (child daytime behavior, parent sleep) will be collected at baseline (weeks 1-2 before starting the treatment), post-treatment (weeks 6-8 from baseline), 6-month follow-up, and 12-month follow-up.
Who can join: Review the eligibility criteria below.
Location: Thompson Center for Autism and Neurodevelopmental Disorders — Columbia, Missouri
Age range: 6 Years to 12 Years
🧪 Interventions in This Study
- In-Person CBT for insomnia in children with autism (BEHAVIORAL)
- Remote CBT for insomnia in children with autism (BEHAVIORAL)
- Remote sleep hygiene and related education (SHARE) for insomnia in children with autism (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Thompson Center for Autism and Neurodevelopmental Disorders — Columbia, Missouri
📞 Contact the Study Coordinator
Phone: (859) 327-7762
Email: mastearns@health.missouri.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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 § 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.
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- Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study) — Montreal, Quebec
- Sleep Learning Education and Empowerment for Older Korean Immigrants — Los Angeles, California
- SLEEP-COPE: Sleep Intervention for Oppositional Children — Tampa, Florida
Explore by condition: All Insomnia Chronic clinical trials
💡 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.