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Adding Printed CBT Materials to a Pediatric Digital Intervention
Sponsor: Neuromotion Labs
Summary
The primary goal of this study is to demonstrate that engaging with "offscreen" physical materials that focus on teaching and practicing Cognitive Behavioral Therapy-based skills alongside a digital emotional regulation intervention results in greater symptom improvement in kids than engaging with the digital intervention alone. Participants are children who are using Mightier a video-game based heart rate biofeedback intervention used to build emotion regulation. Caregivers will be asked to complete a short survey prior to their child's first play and then complete that survey at 12 weeks post baseline. The pre-post self-report design, combined with analyses accounting for engagement with offscreen materials will allow the investigators to observe changes during Mightier use and relate those changes to type of program engagement. (edited)
Official title: Examining the Impact of Adding Printed CBT Materials to a Pediatric Digital Emotional Regulation Intervention
Key Details
Gender
All
Age Range
4 Years - 16 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2024-09-15
Completion Date
2026-02-15
Last Updated
2024-09-19
Healthy Volunteers
No
Conditions
Interventions
Mightier
Mightier is a pediatric at-home intervention program that includes an app-based biofeedback video game that utilizes heart rate (HR) monitoring during game play to teach and facilitate practice of emotional regulation skills in children ages 6-14. The program also uses physical materials including printed workbooks and conversation cards that focus on teaching additional Cognitive Behavioral Therapy (CBT)-based skills and concepts.