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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04545606
The ClinicalTrials.gov registry entry for NCT04545606 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (33% higher). The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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