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NCT04545606 · ClinicalTrials.gov registry record · NA
Targeting Insomnia in School Aged Children With Autism Spectrum Disorder
A NA study of Autism Spectrum Disorder and Insomnia Chronic, sponsored by University of Missouri-Columbia.
- Recruiting
- Registry status
- NA
- Development phase
- 180
- Enrollment target
- 1
- Study location
NCT04545606: Recruiting NA study of Autism Spectrum Disorder and Insomnia Chronic, sponsored by University of Missouri-Columbia.
NCT04545606 is a NA study of Autism Spectrum Disorder and Insomnia Chronic that is actively recruiting participants, run by University of Missouri-Columbia. The registered enrollment target is 180 participants, above the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (33% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04545606, a NA study of Autism Spectrum Disorder and Insomnia Chronic, is actively recruiting participants, sponsored by University of Missouri-Columbia.
- RECRUITING
- Registry status
- NA
- Development phase
- 180 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Conditions Studied
Interventions
- BEHAVIORAL 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
Study Locations (1)
Missouri
- Thompson Center for Autism and Neurodevelopmental Disorders - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2020-09-15 |
| Est. Completion | 2030-08 |
| Phase | NA |
What NCT04545606 shows while recruiting
NCT04545606 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (33% higher).
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 3 interventions - of which In-Person CBT for insomnia in children with autism is the first listed.
NCT04545606 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04545606 about?
NCT04545606 is a clinical study titled "Targeting Insomnia in School Aged Children With Autism Spectrum Disorder". 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...
What is the current status of trial NCT04545606?
This trial is currently recruiting. It is a NA study. The enrollment target is 180 participants. The study started on 2020-09-15. Estimated completion is 2030-08.
What conditions does trial NCT04545606 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Insomnia Chronic.
What interventions are being tested in trial NCT04545606?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT04545606?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04545606 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04545606's enrollment target sits among peer trials
180 47th of 224 higher than 176 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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