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OpenTrials
Completed

NCT Number: NCT04452045

SweetDreams Sleep Study for Children With Autism

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.

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Key information

Age range

12 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

SweetDreams

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.

Primary outcomes

  1. Change in Children's Sleep Habits Questionnaire (CSHQ)

    Time frame: baseline to end of treatment (average exposure 1 month)

    Validated questionnaire; total score range between 33 and 99, with higher numbers representing more sleep problems

Secondary outcomes

  1. Change in Pittsburgh Sleep Quality Index (PSQI)

    Time frame: baseline to end of treatment (average exposure 1 month)

    Validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 30, 2020
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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