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SweetDreams Sleep Study for Children With Autism

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ClinicalTrials.gov Identifier: NCT04452045
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : August 17, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Insomnia Device: SweetDreams Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility of a Sleep Intervention for Children With Autism Spectrum Disorder Study
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SweetDreams
Access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.
Device: SweetDreams
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.

No Intervention: Waitlist Control
Wait list condition with future access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.



Primary Outcome Measures :
  1. Change in Children's Sleep Habits Questionnaire (CSHQ) [ Time Frame: 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 :
  1. Change in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452045


Contacts
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Contact: Lauren Asarnow, PhD 415.476.7439 Lauren.Asarnow@ucsf.edu
Contact: Bennett Leventhal, MD Bennett.Leventhal@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Lauren Asarnow       Lauren.Asarnow@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Lauren Asarnow, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04452045    
Other Study ID Numbers: UL1TR001872 ( U.S. NIH Grant/Contract )
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: August 17, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of California, San Francisco:
sleep
autism
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders