SweetDreams Sleep Study for Children With Autism

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder; Insomnia
• Interventions: Device: SweetDreams

• Registration Number: NCT04452045
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Access to effective treatments for sleep disorders is a persistent challenge. This is due to the lack of trained clinicians as well as caregiver resources to seek out and utilize such critical services. The SweetDreams intervention will solve this problem with on-line delivery of educational materials and treatment strategies for an evidence-based intervention. It will be readily available to caregivers at any time and through multiple outlets such a computer, tablet, and telephone, modes of delivery favored by and effective for parents of children in this age group.

This adaptation will address key challenges to sleep health care for children with ASD: (1) Learning differences of children with ASD by incorporating intervention principles from the TEACHH model; (2) Overcome the challenge of treatment access due to the limited number of qualified providers by developing didactic videos for online and mobile device delivery (referred to as SweetDreams); and, (3) Responding to the NIH emphasis on developing "more effective interventions...by targeting interventions to the identified needs of community members," SweetDreams will use a dynamic process involving extensive collaboration with children, parents, developmental pediatricians, and other experts on youth with ASD.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-25
• Study First Submitted QC: 2020-06-25
• Study First Posted: 2020-06-30
• Study Start: 2020-09-01
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-31
• Status Verified: 2022-12
• Disposition First Submitted: 2022-12-14
• Disposition First Submitted QC: 2022-12-14
• Last Update Submitted: 2022-12-14
• Disposition First Posted: 2022-12-19
• Last Update Posted: 2022-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• have poor sleep health
• have a diagnosis of ASD

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Exclusion Criteria

• 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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SweetDreams	SweetDreams	Access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.

Primary Outcome Measures

Name	Time	Method
Change in Children's Sleep Habits Questionnaire (CSHQ)	baseline to end of treatment (anticipated average exposure 1 month)	Validated questionnaire; total score range between 33 and 99, with higher numbers representing more sleep problems

Secondary Outcome Measures

Name	Time	Method
Change in Pittsburgh Sleep Quality Index (PSQI)	baseline to end of treatment (anticipated average exposure 1 month)	Validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States