Open Label Mightier Play in the Home

NCT05652114 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2732

Last updated 2023-01-04

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05652114 on ClinicalTrials.gov