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Clinical Trials/NCT04452045
NCT04452045
Completed
Not Applicable

Feasibility of a Sleep Intervention for Children With Autism Spectrum Disorder Study

University of California, San Francisco1 site in 1 country20 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
University of California, San Francisco
Enrollment
20
Locations
1
Primary Endpoint
Change in Children's Sleep Habits Questionnaire (CSHQ)
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
December 31, 2021
Last Updated
5 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • have poor sleep health
  • have a diagnosis of ASD

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).

Outcomes

Primary Outcomes

Change in Children's Sleep Habits Questionnaire (CSHQ)

Time Frame: baseline to end of treatment (average exposure 1 month)

Validated questionnaire; total score range between 33 and 99, with higher numbers representing more sleep problems

Secondary Outcomes

  • Change in Pittsburgh Sleep Quality Index (PSQI)(baseline to end of treatment (average exposure 1 month))

Study Sites (1)

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