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SweetDreams Sleep Study for Children With Autism

Primary Purpose

Autism Spectrum Disorder, Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SweetDreams
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring sleep, autism

Eligibility Criteria

12 Months - 60 Months (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SweetDreams

Waitlist Control

Arm Description

Access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.

Wait list condition with future access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.

Outcomes

Primary Outcome Measures

Change in Children's Sleep Habits Questionnaire (CSHQ)
Validated questionnaire; total score range between 33 and 99, with higher numbers representing more sleep problems

Secondary Outcome Measures

Change in Pittsburgh Sleep Quality Index (PSQI)
Validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality

Full Information

First Posted
June 25, 2020
Last Updated
December 14, 2022
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04452045
Brief Title
SweetDreams Sleep Study for Children With Autism
Official Title
Feasibility of a Sleep Intervention for Children With Autism Spectrum Disorder Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Insomnia
Keywords
sleep, autism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SweetDreams
Arm Type
Experimental
Arm Description
Access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
Wait list condition with future access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.
Intervention Type
Device
Intervention Name(s)
SweetDreams
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Children's Sleep Habits Questionnaire (CSHQ)
Description
Validated questionnaire; total score range between 33 and 99, with higher numbers representing more sleep problems
Time Frame
baseline to end of treatment (anticipated average exposure 1 month)
Secondary Outcome Measure Information:
Title
Change in Pittsburgh Sleep Quality Index (PSQI)
Description
Validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality
Time Frame
baseline to end of treatment (anticipated average exposure 1 month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Asarnow, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

SweetDreams Sleep Study for Children With Autism

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