SweetDreams Sleep Study for Children With Autism

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT04452045

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder Insomnia	Device: SweetDreams	N/A

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 Design

Study Type:

Interventional

Actual 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 :

Sep 1, 2020

Actual Primary Completion Date :

Dec 30, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Children's Sleep Habits Questionnaire (CSHQ) [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

Change in Pittsburgh Sleep Quality Index (PSQI) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Months to 60 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94143

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator: Lauren Asarnow, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT04452045

Other Study ID Numbers:

UL1TR001872

First Posted:

Jun 30, 2020

Last Update Posted:

Apr 27, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by University of California, San Francisco

sleep

autism

Additional relevant MeSH terms:

Autistic Disorder

Autism Spectrum Disorder

Study Results

No Results Posted as of Apr 27, 2022