Clinical trial NCT06627205: Sleep Restriction Therapy (SRT) for Sleep Problems in Children With Autism
Official title: Sleep Restriction Therapy (SRT) for Sleep Problems in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder (ASD)
Autism
Keywords: Autism
Sleep
Intervention
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Acceptability of Sleep Restriction Therapy
timeFrame: At end of treatment (approximately week 10)
measure: Tolerability of Sleep Restriction Therapy
timeFrame: At end of treatment (approximately week 10)
measure: Feasibility of Sleep Restriction Therapy
timeFrame: At end of treatment (approximately week 10)
Secondary outcomes:
measure: Change from baseline on the Sleep Disturbance Scale for Children
timeFrame: Screening, Baseline, End of Week 2 Treatment, End of Treatment (approximately week 10)
measure: Change in sleep onset latency (Sleep-Wake Diary)
timeFrame: Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10)
measure: Change in sleep efficiency (Sleep-Wake Diary)
timeFrame: Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10)
measure: Change in wake after sleep onset duration (Sleep-Wake Diary)
timeFrame: Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10)
measure: Change in sleep onset latency (Actigraphy)
timeFrame: Baseline, Week 1, Week 2
measure: Change in sleep efficiency (Actigraphy)
timeFrame: Baseline, Week 1, Week 2
measure: Change in Wake After Sleep Onset (Actigraphy)
timeFrame: Baseline, Week 1, Week 2
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Emma K Baker, MPsych(Clin), PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.