Mightier Play and Caregiver Stress and Wellbeing

NCT05652127 | Completed

• 1 other identifier: NML-2109
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this study is to demonstrate that digital mental health interventions for children, such as Mightier, can have an impact on caregiver functioning, including parenting stress, overall wellbeing, and work engagement. Participants will be caregivers of 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 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

Stress

Keywords

Parent; Stress; Wellbeing

Outcome Measures

Primary Outcomes (1)

• Parental Stress Scale

  The Parental Stress Scale is an 18-item questionnaire assessing parents' feelings about their parenting role, including both positive and negative aspects of parenthood. Scores range from 18 (lower stress) to 90 (higher stress).

  12 weeks

Secondary Outcomes (2)

• The Flourishing Scale

  12 weeks

• Caregiver work and valued activities engagement

  12 weeks

Study Arms (1)

Intervention: Child play of Mightier

EXPERIMENTAL

Ad lib child biofeedback video game play in home

Other: Mightier

Interventions

Mightier OTHER

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 ages 6-14

Intervention: 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
• Parent or caregivers reside in the United States

You may not qualify if:

• None

Sponsors & Collaborators

• Neuromotion Labs: lead

Study Sites (1)

Neuromotion Inc

Boston, Massachusetts, 02111, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• 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: January 9, 2023
• Primary Completion: November 19, 2023
• Study Completion: November 19, 2023
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)