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

NCT ID: NCT06627205

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-11

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Autism Spectrum Disorder (ASD) Autism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sleep Restriction Therapy

Intervention Type BEHAVIORAL

Therapist led sleep restriction therapy sessions.

Interventions

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Sleep Restriction Therapy

Therapist led sleep restriction therapy sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Antonio Hardan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emma K Baker, MPsych(Clin), PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Emma K Baker, MPsych(Clin), PhD

Role: CONTACT

6507361235

Robin Libove, BS

Role: CONTACT

6507361235

Facility Contacts

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Emma Baker, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 35635067 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35712855 (View on PubMed)

Other Identifiers

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IRB-76796

Identifier Type: -

Identifier Source: org_study_id

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