SweetDreams Sleep Study for Children With Autism

University of California San Francisco (UCSF)

Status: Completed

Conditions: Autism Spectrum Disorder; Insomnia

Treatments: Device: SweetDreams

Study type: Interventional

Funder types: Other

Identifiers

NCT04452045

UL1TR001872

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 12 to 60 months old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

SweetDreams

Experimental group

Description:

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

Treatment:

Device: SweetDreams

Waitlist Control

No Intervention group

Description:

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