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NOT YET RECRUITING
NCT06580496
NA

Adding Printed CBT Materials to a Pediatric Digital Intervention

Sponsor: Neuromotion Labs

View on ClinicalTrials.gov

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

Interventions

BEHAVIORAL

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.