SweetDreams Sleep Study for Children With Autism
Feasibility of a Sleep Intervention for Children With Autism Spectrum Disorder Study
1 other identifier
interventional
20
1 country
1
Brief Summary
This proposal will acquire preliminary data on the feasibility and effectiveness of an innovative and scalable strategy for improving access to effective sleep health care for preschool-aged children with Autism Spectrum Disorder (ASD). The investigators will develop and test an on-line delivery adaptation of the existing behavioral sleep interventions for preschool aged children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2020
CompletedFirst Posted
Study publicly available on registry
June 30, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedResults Posted
Study results publicly available
December 2, 2025
CompletedDecember 2, 2025
November 1, 2025
1.3 years
June 25, 2020
April 24, 2023
November 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Children's Sleep Habits Questionnaire (CSHQ)
Validated questionnaire; total score range between 33 and 99, with higher numbers representing more sleep problems
baseline to end of treatment (average exposure 1 month)
Secondary Outcomes (1)
Change in Pittsburgh Sleep Quality Index (PSQI)
baseline to end of treatment (average exposure 1 month)
Study Arms (2)
SweetDreams
EXPERIMENTALAccess to a mobile and computer accessible adaptation of existing evidence based sleep interventions.
Waitlist Control
NO INTERVENTIONWait list condition with future access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.
Interventions
SweetDreams is a mHealth adaptation of existing evidence-based sleep interventions. It is a user friendly and developmentally appropriate modularized 4-week web-based intervention available on computer, tablet or mobile phones.
Eligibility Criteria
You may qualify if:
- have poor sleep health
- have a diagnosis of ASD
You may not qualify if:
- any regular sleep medication use (this does not include occasional over the counter sleep aid)
- known sleep apnea
- unstable major medical conditions (e.g. severe asthma, diabetes).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lauren Asarnow
- Organization
- University of California, San Francisco
Study Officials
- PRINCIPAL INVESTIGATOR
Lauren Asarnow, PhD
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2020
First Posted
June 30, 2020
Study Start
September 1, 2020
Primary Completion
December 30, 2021
Study Completion
December 31, 2021
Last Updated
December 2, 2025
Results First Posted
December 2, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share