Clinical trial NCT04452045: SweetDreams Sleep Study for Children With Autism
Official title: Feasibility of a Sleep Intervention for Children With Autism Spectrum Disorder Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Insomnia
Keywords: sleep
autism
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Children's Sleep Habits Questionnaire (CSHQ)
timeFrame: baseline to end of treatment (anticipated average exposure 1 month)
Secondary outcomes:
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline to end of treatment (anticipated average exposure 1 month)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Lauren Asarnow, PhD
role: PRINCIPAL_INVESTIGATOR
References: