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: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (11 items).
Location: Thompson Center for Autism and Neurodevelopmental Disorders — Columbia, Missouri
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 1\) parent unable to provide informed consent or child unable to provide assent
- 2\) unwilling to accept random assignment
- 3\) participation in another randomized research project
- 4\) parent unable to complete forms or implement treatment procedures due to cognitive impairment
- 5\) untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, \[frequent\] parasomnias)
- 6\) psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin as described in #7 (see Notes below for details)
- 7\) stimulants, sleep medications (prescribed or OTC), and/or melatonin within the last 1 month (unless stabilized on medication for 3+ months)
- 8\) participation in non-pharmacological treatment (including CBT) for sleep outside current trial
- 9\) parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)
- 10\) other conditions adversely affecting trial participation
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Thompson Center for Autism and Neurodevelopmental Disorders — Columbia, Missouri
💰 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.