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

NCT06627205 | Recruiting

• 1 other identifier: IRB-76796
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

Autism; Sleep; Intervention

Outcome Measures

Primary Outcomes (3)

• 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.

  At end of treatment (approximately week 10)

• 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.

  At end of treatment (approximately week 10)

• 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.

  At end of treatment (approximately week 10)

Secondary Outcomes (7)

• Change from baseline on the Sleep Disturbance Scale for Children

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

• Change in sleep onset latency (Sleep-Wake Diary)

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

• Change in sleep efficiency (Sleep-Wake Diary)

  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)

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

• Change in sleep onset latency (Actigraphy)

  Baseline, Week 1, Week 2

Study Arms (1)

Sleep Restriction Therapy

EXPERIMENTAL

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

Interventions

Sleep Restriction Therapy BEHAVIORAL

Therapist led sleep restriction therapy sessions.

Sleep Restriction Therapy

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 35635067 BACKGROUND

• 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.

  PMID: 35712855 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Emma K Baker, MPsych(Clin), PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma K Baker, MPsych(Clin), PhD

CONTACT

6507361235; ekbaker@stanford.edu

Robin Libove, BS

CONTACT

6507361235; rlibove@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 4, 2024
• Study Start: February 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 16, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)