SweetDreams Sleep Study for Children With Autism

NCT ID: NCT04452045

Last Updated: 2022-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Spectrum Disorder Insomnia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

sleep autism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SweetDreams

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

Group Type EXPERIMENTAL

SweetDreams

Intervention Type DEVICE

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.

Waitlist Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

12 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lauren Asarnow, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UL1TR001872

Identifier Type: NIH

Identifier Source: org_study_id

View Link