Open Label Mightier Play in the Home

NCT05652114 | Completed

• 1 other identifier: NML
• Study Type: interventional
• Target: 2,732
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Affective Reactivity Index - Parent

  The Affective Reactivity Index is a 7 item parent reported measure of irritability. Scores range from 0-12, with higher scores representing greater irritability.

  12 weeks

• Modified Overt Aggression Scale

  The Modified Overt Aggression Scale is a 4 item, caregiver report measure of verbal aggression, physical aggression, aggression against property, and autoaggression. Scores range from 0 to 40, with higher scores indicating more aggression.

  12 weeks

Secondary Outcomes (2)

• Screen for Anxiety Related Emotional Disorders

  12 weeks

• National Institute for Children's Health Quality Vanderbilt Assessment Scale

  12 weeks

Study Arms (1)

Child play of Mightier

EXPERIMENTAL

Ad lib child biofeedback video game play in home

Behavioral: Mightier

Interventions

Mightier BEHAVIORAL

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.

Child play of Mightier

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parent or caregivers have a child engaging with the heart rate biofeedback intervention Mightier

You may not qualify if:

• None

Sponsors & Collaborators

• Neuromotion Labs: lead

Study Sites (1)

Neuromotion Inc

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Scientist

Model Details: As a single arm study all participants' children will receive a game-based biofeedback intervention. They are encouraged to engage with the intervention in an entirely self-directed manner.

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: April 10, 2020
• Primary Completion: November 17, 2022
• Study Completion: November 17, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)