Mightier Play and Caregiver Stress and Wellbeing

Examining the Impact of Child Mightier Play on Caregiver Stress and Wellbeing

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.

Study Overview

• Status: Recruiting
• Conditions: Stress
• Intervention / Treatment: Other: Mightier

Detailed Description

Providing care for children with mental illness is associated with significant caregiver burden that manifests in physical, psychological, and social ways. Caregiver burden is largely associated with child symptom severity. As such, reducing child symptom severity should reduce caregiver burden. Yet, caregiver burden is not commonly assessed as an outcome of mental health interventions and little is known about the impact of child-focused novel digital mental health interventions on caregiver burden.

Mightier is an app-based biofeedback video game platform that utilizes heart rate (HR) monitoring during game play to teach and facilitate practice of emotional regulation skills in children. The effectiveness of Mightier has been supported through several studies in children ages 8-18, specifically reducing symptoms of aggression, oppositional behavior, and parental stress. While prior work has supported that Mightier as a child-based intervention also decreases parent stress, we have not examined if child use of Mightier meaningfully impacts caregiver wellbeing, or if these changes translate to changes in work engagement or absenteeism. The proposed study will be a single arm trial where parents and caregivers who have purchased Mightier will complete baseline and follow up self-report measures assessing presenteeism, absenteeism, parenting stress, and overall wellbeing.

For this proposed study we hypothesize the following:

1. Participants will report significant reduction in parent stress and absenteeism and a significant increase in overall wellbeing and presenteeism.
2. Changes in participant stress will be negatively associated with child minutes of Mightier use and changes in participant wellbeing will be positively associated with child minutes of Mightier use.
3. Children of participants who report positive change in work productivity (increases in presenteeism or decreases in absenteeism) will have used Mightier significantly more than those who do not report positive change.

For the duration of the 8-12 week intervention period, participants will play Mightier and engage with Mightier parent content ad libitum. They will not receive any special instructions or recommendations outside of those provided to all Mightier families. Consistent with any other family using Mightier, participating families will be free to engage with or deny all programming associated with Mightier (e.g. email updates and other support). All individuals engaging with participating families to facilitate the standard Mightier experience will be blinded to their participation in research.

Participating families will be contacted via email to complete follow-up measures. These emails will be sent 1) 8 weeks after participants complete the first assessment and 2) 12 weeks after participants complete their first assessment. Participants will be sent the 12 week follow up email regardless of 8 week follow up assessment completion. Participants will only be sent these emails if they are customers of Mightier at the time of follow up.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alyssa Peechatka, PhD; Phone Number: 8145743458; Email: alyssa.peechatka@gmail.com
• Study Contact Backup: Name: Jason Kahn, PhD; Phone Number: 6172305659; Email: jason@mightier.com

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Neuromotion Inc
      • Contact: Jason Kahn, PhD; Phone Number: 6172305659; Email: jason@mightier.com
      • Contact: Alyssa L Peechatka, PhD; Phone Number: 814-574-3458; Email: alyssa@mightier.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parent or caregivers have a child engaging with the heart rate biofeedback intervention Mightier
• Parent or caregivers reside in the United States

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: Child play of Mightier; Ad lib child biofeedback video game play in home	Other: 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 ages 6-14

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Flourishing Scale	The Flourishing Scale is a brief 8-item measure of self-perceived success in important areas of functioning such as relationships, self-esteem, purpose, and optimism. Scores range from 8 to 56, where high scores represent greater levels of self-perceived success.	12 weeks
Caregiver work and valued activities engagement	1-5 items (depending on current employment status) measuring work absenteeism, work engagement, and valued activities engagement. The first question is an open ended numerical input of workdays missed to provide behavioral or mental health support to their child. The 4 following questions are Leikert-type questions ranging from strongly agree to strongly disagree, with strongly agree representing greater impairment of function. These questions have not been independently validated and are not a part of a formalized scale.	12 weeks

Collaborators and Investigators

• Sponsor: Neuromotion Labs

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Wellbeing; Stress; Parent
• Other Study ID Numbers: NML-2109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No