Sleep Restriction Therapy (SRT) for Sleep Problems in Children With Autism

May 13, 2025 updated by: Antonio Hardan, Stanford University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Sleep Restriction Therapy
Therapist led sleep restriction therapy sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of Sleep Restriction Therapy
Time Frame: At end of treatment (approximately week 10)
Acceptability will be assessed using a series of questions rated by participants on a 5-point Likert scale (1-5) with 1 being the least acceptable and 5 being the most acceptable.
At end of treatment (approximately week 10)
Tolerability of Sleep Restriction Therapy
Time Frame: At end of treatment (approximately week 10)
Tolerability will be assessed using a series of questions rated by participants on a 5-point Likert scale (1-5) with 1 being the least tolerable and 5 being the most tolerable.
At end of treatment (approximately week 10)
Feasibility of Sleep Restriction Therapy
Time Frame: At end of treatment (approximately week 10)
Feasibility will be assessed using a series of questions rated by participants on a 5-point Likert scale (1-5) with 1 being the least feasible and 5 being the most feasible.
At end of treatment (approximately week 10)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline on the Sleep Disturbance Scale for Children
Time Frame: Screening, Baseline, End of Week 2 Treatment, End of Treatment (approximately week 10)
The Sleep Disturbance Scale for Children (SDSC) evaluates various sleep disorders including difficulties in falling asleep and staying asleep, sleep-disordered breathing, arousal disorders, sleep-wake transition disorders, excessive sleepiness, and excessive sweating during sleep. Scores range from 26 to 130. Higher scores on the SDSC are indicative of greater sleep disturbance. This outcome measure will determine the effectiveness of sleep restriction therapy in improving sleep disturbances in children with autism spectrum disorder.
Screening, Baseline, End of Week 2 Treatment, End of Treatment (approximately week 10)
Change in sleep onset latency (Sleep-Wake Diary)
Time Frame: Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10)
This study utilizes a brief sleep-wake diary to collect parent-reported sleep variables (e.g., what time did your child try to sleep last night). Average sleep onset latency will be calculated from the diary for the purposes of this study.
Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10)
Change in sleep efficiency (Sleep-Wake Diary)
Time Frame: Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10)
This study utilizes a brief sleep-wake diary to collect parent-reported sleep variables (e.g., what time did your child try to sleep last night). Average sleep efficiency will be calculated from the diary for the purposes of this study.
Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10)
Change in wake after sleep onset duration (Sleep-Wake Diary)
Time Frame: Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10)
This study utilizes a brief sleep-wake diary to collect parent-reported sleep variables (e.g., what time did your child try to sleep last night). Average wake after sleep onset will be calculated from the diary for the purposes of this study.
Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10)
Change in sleep onset latency (Actigraphy)
Time Frame: Baseline, Week 1, Week 2
Children wear an actigraphy monitor for the purposes of collecting objective information about sleep onset latency (time taken to fall asleep).
Baseline, Week 1, Week 2
Change in sleep efficiency (Actigraphy)
Time Frame: Baseline, Week 1, Week 2
Children wear an actigraphy monitor for the purposes of collecting objective information about sleep efficiency (percentage of time in bed that the child is actually asleep).
Baseline, Week 1, Week 2
Change in Wake After Sleep Onset (Actigraphy)
Time Frame: Baseline, Week 1, Week 2
Children wear an actigraphy monitor for the purposes of collecting objective information about wake after sleep onset duration (the amount of time spent awake after falling asleep)
Baseline, Week 1, Week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Emma K Baker, MPsych(Clin), PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

October 2, 2024

First Submitted That Met QC Criteria

October 2, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-76796

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No current plan to share data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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