SweetDreams Sleep Study for Children With Autism

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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Autism Spectrum Disorder
• Intervention / Treatment: Device: SweetDreams

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (anticipated average exposure 1 month)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: sleep; autism
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: UL1TR001872 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes