Clinical trial Recruiting at 1 site Interventional Ages 6 to 12

Sleep therapy for children with autism and sleep issues

Official title: Sleep Restriction Therapy (SRT) for Sleep Problems in Children With Autism Spectrum Disorder

Run by Stanford University · NCT06627205 · Data updated 2026-11-12

This study is testing a new sleep therapy delivered online to see if it can help children with autism who have trouble sleeping.

Quick facts

Study typeInterventional
Ages6 Years to 12 Years
SexAll
Enrollment25 (estimated)
SponsorStanford University
Academic / other
Locations1 site (Stanford, California)
StatusRecruiting
StartedFebruary 11, 2025
Main results expectedDecember 2026
Study endsDecember 2027
Registry record updatedMay 16, 2025
Trial IDNCT06627205 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children diagnosed with autism spectrum disorder who experience sleep disturbances and have stable medication plans.

Probably not a fit

Patients with severe psychiatric disorders, unstable medical problems, or primary circadian rhythm sleep-wake disorders may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open label trial aims to evaluate the acceptability, tolerability, feasibility, and preliminary effectiveness of sleep restriction therapy for addressing sleep problems in children diagnosed with autism spectrum disorder (ASD). The intervention will be delivered through a secure telemedicine platform, where parents will receive training to implement the therapy. The study focuses on children experiencing sleep disturbances, ensuring a structured approach to improve their sleep quality.

Why it matters

Potential benefit: If successful, this therapy could significantly improve sleep quality and overall well-being for children with autism.

How similar studies have gone: Other studies have shown promise in using behavioral interventions for sleep issues in children with autism, suggesting potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* diagnosed with autism spectrum disorder (based on history, review of available medical records including diagnostic testing, e.g., Autism Diagnostic Observation Schedule and/or Autism Diagnostic Interview-Revised, Childhood Autism Rating Scale-2)
* with sleep disturbances (based on clinical interview, and Sleep Disturbance Scale for Children score \> 38)
* stable pre-existing medication plans for at least 2 weeks
* no planned changes in psychosocial and biomedical interventions during the intervention
* an English-speaking parent able to consistently participate in study procedures
* reside in California, USA

Exclusion Criteria:

* parent or child diagnosed with severe psychiatric disorder or unstable medical problem
* children with active seizures or epilepsy
* primary sleep disorder is a circadian rhythm sleep-wake disorder, as determined by the sleep interview and Children's ChronoType Questionnaire.
* current active trial of sleep restriction therapy or history of an adequate trial of sleep restriction therapy.

Where it's running

  • Stanford University
    Stanford, California, United States
    Recruiting

Study contacts

  • Principal investigator: Emma K Baker, MPsych(Clin), PhD — Stanford University
  • Study coordinator: Emma K Baker, MPsych(Clin), PhD
  • Email: ekbaker@stanford.edu
  • Phone: 6507361235

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.