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RECRUITING NA

Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

NCT04545606 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 180 participants
Start Date 2020-09-15
Est. Completion 2030-08
Phase NA

Sponsor

University of Missouri-Columbia

275 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Missouri-Columbia, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04545606 reports 1 study location spanning 1 distinct geographic area — top geographies include Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04545606?

This trial is sponsored by University of Missouri-Columbia, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial