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Autism Spectrum Disorder (ASD)NCT06627205

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

A study testing Sleep Restriction Therapy in people with Autism Spectrum Disorder (ASD) and Autism, run by Stanford University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Autism Spectrum Disorder (ASD), Autism
What is being tested?
Sleep Restriction Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
11 Feb 2025to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emma K Baker, MPsych(Clin), PhD contact

6507361235

ekbaker@stanford.edu

Robin Libove, BS contact

6507361235

rlibove@stanford.edu

United States1 site, 1 recruiting

  • Stanford University

    Stanford, California, 94305

    Emma Baker, PhD, ekbaker@stanford.edu.au

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
Sleep Restriction Therapy
Keywords
Autism, Sleep, Intervention
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep Restriction TherapyBehavioural

    Therapist led sleep restriction therapy sessions.

Study groups in NCT06627205
Study groupRoleWhat they receive
Sleep Restriction TherapyExperimentalParticipants 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.
Receives: Behavioral: Sleep Restriction Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptability of Sleep Restriction Therapy

    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.

    Measured: At end of treatment (approximately week 10)

  2. Tolerability of Sleep Restriction Therapy

    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.

    Measured: At end of treatment (approximately week 10)

  3. Feasibility of Sleep Restriction Therapy

    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.

    Measured: At end of treatment (approximately week 10)

Secondary outcomes (7)

  1. Change from baseline on the Sleep Disturbance Scale for Children

    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.

    Measured: Screening, Baseline, End of Week 2 Treatment, End of Treatment (approximately week 10)

  2. Change in sleep onset latency (Sleep-Wake Diary)

    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.

    Measured: Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10)

  3. Change in sleep efficiency (Sleep-Wake Diary)

    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.

    Measured: Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10)

  4. Change in wake after sleep onset duration (Sleep-Wake Diary)

    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.

    Measured: Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10)

  5. Change in sleep onset latency (Actigraphy)

    Children wear an actigraphy monitor for the purposes of collecting objective information about sleep onset latency (time taken to fall asleep).

    Measured: Baseline, Week 1, Week 2

  6. Change in sleep efficiency (Actigraphy)

    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).

    Measured: Baseline, Week 1, Week 2

  7. Change in Wake After Sleep Onset (Actigraphy)

    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)

    Measured: Baseline, Week 1, Week 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2024
  2. Study start11 Feb 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06627205
Sponsor's protocol ID
IRB-76796
Status last verified
Oct 2024
First submitted
2 Oct 2024
Last updated
16 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No current plan to share data.

Publications

  • Han GT, Trevisan DA, Abel EA, Cummings EM, Carlos C, Bagdasarov A, Kala S, Parker T, Canapari C, McPartland JC. Associations between sleep problems and domains relevant to daytime functioning and clinical symptomatology in autism: A meta-analysis. Autism Res. 2022 Jul;15(7):1249-1260. doi: 10.1002/aur.2758. Epub 2022 May 30.

    PubMed 35635067

  • Cain N, Richardson C, Bartel K, Whittall H, Reeks J, Gradisar M. A randomised controlled dismantling trial of sleep restriction therapies for chronic insomnia disorder in middle childhood: effects on sleep and anxiety, and possible contraindications. J Sleep Res. 2022 Dec;31(6):e13658. doi: 10.1111/jsr.13658. Epub 2022 Jun 17.

    PubMed 35712855

Questions about this trial

What is this clinical trial studying?

A study testing Sleep Restriction Therapy in people with Autism Spectrum Disorder (ASD) and Autism, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emma K Baker, MPsych(Clin), PhD (6507361235, ekbaker@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of Sleep Restriction Therapy (time frame: At end of treatment (approximately week 10)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06627205, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.

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