Examining the Impacts of Parent Mightier Play

Neuromotion Labs

Status: Completed

Conditions: Emotional Regulation

Treatments: Behavioral: Mightier online gameplay

Study type: Interventional

Funder types: Industry

Identifiers

NCT05080647

995MIGH21

Details and patient eligibility

About

A randomized controlled trial comparing a group in which only child participants play Mightier video games for 8 weeks (Child Play group) to a group in which child and parent participants play Mightier video games for 8 weeks (Child and Parent Play group).

Full description

Mightier is a mobile app-based biofeedback video game platform that facilitates emotion regulation skill-building among children ages 6-14. The technology behind Mightier's mobile app has been validated in two independent sham-controlled randomized controlled trials, where the investigators have seen decreases in clinical symptoms of aggression and disruptive behaviors, as well as lowered family stress without adverse events.

The study utilizes a parallel randomized controlled design comparing groups of participant families whose children play Mightier video games without parent play to groups of participant families in which both children and parents play Mightier video games. Self-report measures will be completed by participant children and parents.

The study consists of three primary phases: Pre-Study, Active Engagement, and Follow-Up. During the Pre-Study Phase, participants will undergo pre-screening and screening to evaluate interest and eligibility for the study, and participants who consent to participate in the study will complete baseline measures and be randomized into treatment groups. Mightier games will be shipped to participants during or shortly after their Pre-Study call. Participants will be instructed to begin Mightier gameplay as soon as Mightier games arrive at their homes, which will begin the Active Engagement Phase of the study.

During the 8-week Active Engagement Phase, participants will be encouraged to play Mightier games in a way that corresponds to their study condition, and they will be offered engagement support in the form of brief weekly check-ins.

After completion of the Active phase, participants will have a brief Follow-up phase, consisting of one video call during which child and parent participants will complete self-report follow-up measures.

Enrollment: 41 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 6-12 at the time of screening
• Regular access to WiFi (for Mightier gameplay device connection)

Exclusion criteria

• Prior Mightier use
• Diagnosed Intellectual Disability (by history)
• Planned medication changes during the 8-week study period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Mightier Child Play

Active Comparator group

Description:

8 weeks of use ad-libitum. Parents will be encouraged to have their children play Mightier games at least 3 times a week (totalling 45 minutes or more play each week) for the 8-week duration. Parents in the Child Play condition will be advised specifically to not play Mightier for the 8-week duration of the study.

Treatment:

Behavioral: Mightier online gameplay

Mightier Child and Parent Play

Experimental group

Description:

8 weeks of use ad-libitum. Parents will be encouraged to have their children play Mightier games at least 3 times a week (totalling 45 minutes or more of play each week) for the 8-week duration. Additionally, parents in the Child and Parent Play condition will be encouraged to play Mightier games at least once a week (totalling 15 minutes or more of play each week) for the 8-week duration.

Treatment:

Behavioral: Mightier online gameplay