SweetDreams Sleep Study for Children With Autism

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Autism Spectrum Disorder, Insomnia

Intervention / Treatment
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* Device: SweetDreams


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SweetDreams<br>Access to a mobile and computer accessible adaptation of existing evidence based sleep interventions. | Device: SweetDreams<br>* 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.<br>|
| No Intervention: Waitlist Control<br>Wait list condition with future access to a mobile and computer accessible adaptation of existing evidence based sleep interventions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Children's Sleep Habits Questionnaire (CSHQ) | Validated questionnaire; total score range between 33 and 99, with higher numbers representing more sleep problems | baseline to end of treatment (anticipated average exposure 1 month) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pittsburgh Sleep Quality Index (PSQI) | Validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality | baseline to end of treatment (anticipated average exposure 1 month) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, autism