Recruiting

Sleep Restriction Therapy

Sponsor:

Stanford University

Code:

NCT06627205

Conditions

Autism Spectrum Disorder (ASD)

Autism

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Not accepted

Interventions

Sleep Restriction Therapy

Study Details

Brief summary:

The purpose of this open label trial is to examine the acceptability, tolerability, and feasibility and preliminary effectiveness of sleep restriction therapy for sleep problems in children with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of parent-training in delivering the intervention.

Conditions

Autism Spectrum Disorder (ASD)

Autism

Study ID

NCT06627205

Start date

Feb 11, 2025

Status verified date

Oct, 2024

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sleep Restriction Therapy

Participants attend telehealth sessions once per week for three weeks and implement sleep restriction therapy in between sessions and for 4 weeks during a follow-up period.

Interventions

Sleep Restriction Therapy

Therapist led sleep restriction therapy sessions.

Primary outcome measure

  • Acceptability of Sleep Restriction Therapy [ Time Frame: At end of treatment (approximately week 10) ]
  • Tolerability of Sleep Restriction Therapy [ Time Frame: At end of treatment (approximately week 10) ]
  • Feasibility of Sleep Restriction Therapy [ Time Frame: At end of treatment (approximately week 10) ]

Central Contacts and Locations

Central contacts

Emma K Baker, MPsych(Clin), PhD

6507361235ekbaker@stanford.edu

Robin Libove, BS

6507361235rlibove@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Emma Baker, PhD

ekbaker@stanford.edu.au

More Information

Sponsor

Stanford University

Last update posted

May 16, 2025

Last verified

Oct, 2024

Keywords

  • Autism
  • Sleep
  • Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-05-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.