Sleep therapy for children with autism and sleep issues
Sleep Restriction Therapy (SRT) for Sleep Problems in Children With Autism Spectrum Disorder
NA · Stanford University · NCT06627205
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Stanford University (other) |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT06627205 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children diagnosed with autism spectrum disorder who experience sleep disturbances and have stable medication plans.
Not a fit: Patients with severe psychiatric disorders, unstable medical problems, or primary circadian rhythm sleep-wake disorders may not benefit from this study.
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 performed: Other studies have shown promise in using behavioral interventions for sleep issues in children with autism, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Stanford, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autism Spectrum Disorder, Autism, Sleep, Intervention