Open Label Mightier Play in the Home
NCT05652114 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2732
Last updated 2023-01-04
Summary
Mightier is a digital mental health tool that uses video game-based heart rate biofeedback to teach emotion regulation. The primary goal of this study is to replicate results from original clinical trials, demonstrating that playing Mightier at home improves common symptoms associated with emotional dysregulation.
Participants will be caregivers of children who are using Mightier, a video-game based heart rate biofeedback intervention. Caregivers will be asked to complete a short survey about their child's emotions and behaviors prior to their child's first play and then complete that survey two more times, at 8 weeks and 12 weeks post baseline.
The pre-post self report design will allow us to observe changes during Mightier use and relate those changes to overall engagement with the intervention
Conditions
- Emotional Regulation
Interventions
- BEHAVIORAL
-
Mightier
Mightier is 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.
Sponsors & Collaborators
-
Neuromotion Labs
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-04-10
- Primary Completion
- 2022-11-17
- Completion
- 2022-11-17
Countries
- United States
Study Locations
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