Targeting Insomnia in School Aged Children With Autism Spectrum Disorder
Who can join
Ages 6 to 12 · All sexes
Full eligibility criteria
Inclusion Criteria: * 1\) 6-12a yrs * 2\) Verbal IQ \>= 70 * 3\) participation of child's parent or legal guardian living in the same home * 4\) parent/guardian ability to read and understand English at the 5th-grade level * 5\) child diagnosed with ASD and insomnia ASD: * 1\) previous DSM diagnosis of ASD * 2\) evaluation using gold-standard diagnostic tools (i.e., Autism Diagnostic Observation Schedule (ADOS) and/or Autism Diagnostic Interview-Revised \[ADI-R\]) Insomnia: * 1\) complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos * 2\) daytime dysfunction (mood, cognitive, social, academic) due to insomnia * 3\) baseline diaries and actigraphy indicate \>30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening (time between last awakening and out of bed time) on 6+ nights 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
About the study
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.
What is being tested
- 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)
Sponsor: University of Missouri-Columbia · Participants: 180 · Started: Sep 15, 2020
Contact the study team
- Melanie Stearns, PhD · Phone: 859-327-7762
- Sydney Shoemaker, MS · Phone: 573-882-5113
Official record on ClinicalTrials.gov — NCT04545606
Locations in the U.S.
| Missouri | Thompson Center for Autism and Neurodevelopmental Disorders, Columbia |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.