Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06627205

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Autism Spectrum Disorder (ASD) Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Emma Baker, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sleep Restriction Therapy

Behavioral

Therapist led sleep restriction therapy sessions.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

  7. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Emma K Baker, MPsych(Clin), PhD

CONTACT

[email protected]

6507361235

Robin Libove, BS

CONTACT

[email protected]

6507361235

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 4, 2024
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.