Recruiting NCT06627205
Sleep Restriction Therapy (SRT) for Sleep Problems in Children With Autism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sleep Restriction Therapy.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder (ASD), Autism. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Sleep Restriction Therapy (SRT) for Sleep Problems in Children With Autism Spectrum Disorder
Overview
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.
Interventions
- Behavioral Sleep Restriction Therapy
Therapist led sleep restriction therapy sessions.
Primary outcome measures
- Acceptability of Sleep Restriction Therapy [Time frame: At end of treatment (approximately week 10)]
- Tolerability of Sleep Restriction Therapy [Time frame: At end of treatment (approximately week 10)]
- Feasibility of Sleep Restriction Therapy [Time frame: At end of treatment (approximately week 10)]
Secondary outcome measures (7)
- 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)]
- 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)]
- 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)]
- 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)]
- Change in sleep onset latency (Actigraphy) [Time frame: Baseline, Week 1, Week 2]
- Change in sleep efficiency (Actigraphy) [Time frame: Baseline, Week 1, Week 2]
- Change in Wake After Sleep Onset (Actigraphy) [Time frame: Baseline, Week 1, Week 2]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stanford University — Stanford
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. PMID 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. PMID 35712855
Identifiers
NCT: NCT06627205 · IRB-76796