SweetDreams Sleep Study for Children With Autism

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04452045
• Other study ID #: UL1TR001872
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 60 Months

Eligibility

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).

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Insomnia

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)