Insufficient sleep in children is recognized by Congress and the Department of Health and Human Services as a high priority target for clinical scientific investigation given its consist link with enduring physical, emotional and behavioral problems, including overweight/obesity, inattention, hyperactivity, learning problems, conduct problems, substance use, anxiety, and depression. Behaviorally-based interventions have been proven efficacious for pediatric sleep difficulties and disorders, but they remain under utilized, with approximately 80% [37] of children being prescribed sleep medication despite no FDA approved medications for this population. Given that up to 70% of children in the U.S. age 10 and under experience a sleep problem several times per week [1], and researchers have shown behavioral sleep interventions to be efficacious, we must address this under-utilization by developing more accessible, affordable, and engaging interventions for children and their caregivers. Software-based interventions offer an improved means of disseminating empirically-supported treatments for sleep directly to families, just as they have other pediatric conditions such as diabetes, asthma, and social anxiety. However, in light of the myriad of web-based interventions currently available, software alone does not address issues associated with under-utilization. Development and incorporation of more interactive, experiential, and game-based components such as virtual reality (VR) and token economies, will lead to greater engagement and motivation for use, ultimately resulting in better treatment outcomes. This technological paradigm shift to more experientially, context-based, and interactive content offers distinct advantages over traditional interventions in its ability to provide virtual skills-based practice with real-time feedback, opportunities for entertaining gaming, and more engaging formats of psychoeducation. Utilization of VR technology as part of an internet-delivered behavioral treatment program for children is a novel approach to ensuring access to evidence-based care and optimizing outcomes. This intervention will be the first program for children with sleep problems to leverage a web-based platform that is engaging, educational, skills-based, and easily accessible. This Phase I SBIR will build an intervention called Ready, Set, Snooz"""""""", a user-friendly, interactive, and affordable web-based treatment program with a high potential for broad dissemination, adaptation and commercialization across different disease conditions beyond Phase II. This web-based intervention will consist of three Clinical Components: 1) Sleep Tracking, 2) Education/Skill Development, and 3) Virtual Sleep Training. All information will be presented in a sequenced format as to build upon skills already learned/practiced. Additionally, an imbedded virtual game will be available to all users who can exchange virtual tokens earned during the intervention for virtual game content and access to new game levels, a methodology common among many smart device games today. We will evaluate the feasibility, credibility, and acceptability of the treatment program, as well as initial clinical efficacy basedon knowledge, motivation/self- efficacy, and changes in actual sleep patterns and behaviors. Our intervention, Ready, Set, Snooz"""""""", will represent the first prescriptive, engaging, and interactive web-based intervention for school-aged children with sleep difficulties, requiring active participation by both the child and parent. We believe this intervention will surpass existing approaches for child-focused software programs based on its novelty, aesthetics, ease of use, and acceptance/promotion by health care professionals and families. If successful, we envision that the VR program will serve as a template for interactive VR interventions for children with other conditions requiring self-management, such as asthma, diabetes, and food allergies. The promise of commercial opportunity is significant in an era in which there is increasingly widespread access to and everyday use of computers, smart phones, and tablet technologies.

Public Health Relevance

Insufficient sleep in children is recognized by Congress and the Department of Health and Human Services as a high priority target for clinical scientific investigation given its consistent association with enduring physical, emotional and behavioral problems. Behaviorally-based interventions have been shown efficacious for pediatric sleep problems, but they remain under utilized and disseminated. Ready, Set, Snooz, a prescriptive, interactive, web-based intervention with high potential for broad dissemination and commercialization, will fill this critical service need among children with behavioral sleep problems.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43HD075548-01
Application #
8455977
Study Section
Special Emphasis Panel (ZRG1-RPHB-C (10))
Program Officer
Mann Koepke, Kathy M
Project Start
2013-06-01
Project End
2014-08-31
Budget Start
2013-06-01
Budget End
2014-08-31
Support Year
1
Fiscal Year
2013
Total Cost
$257,942
Indirect Cost
Name
Virtually Better, Inc.
Department
Type
DUNS #
010776370
City
Decatur
State
GA
Country
United States
Zip Code
30033