Examining the Impacts of Parent Mightier Play

NCT05080647 | Completed

• 1 other identifier: 995MIGH21
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Emotional Regulation

Outcome Measures

Primary Outcomes (3)

• Change in child behavior and emotion problems measured on BFS at Week 8

  Behavior and Feelings Survey (BFS): The BFS (Weisz et al., 2014) is a 12-item scale measuring child behavior and emotion problems. The child's parent is prompted to read the survey questions to the child and to note the child's responses. The researcher will screen share the BFS form and record child responses in the form. Children will complete the BSF at baseline and Week 8. Items are rated on a scale from 0 (not a problem) to 4 (a very big problem). Three scale scores can be derived: Internalizing Problems (sum of items 1-6), Externalizing Problems (sum of items 7-12), and Total Problems (sum of items 1-12).

  Baseline and Week 8

• Change in child irritability from baseline measured on ARI-P at Week 8

  Affective Reactivity Index-Parent Report (ARI-P): The ARI is a 7-item scale that consists of 6 symptom items and 1 impairment item. The scale was designed to determine irritable mood rather than behavioral consequences such as hostility and acts of aggression (Stringaris et al., 2012). The individual items are scored 0,1, 2, and only the first six items are summed to form the total score, with a minimum score of 0 and a maximum score of 18, and higher scores indicating greater severity of irritability symptoms. The seventh item is an impairment item and it is analysed separately, with a minimum score of 0 and a maximum score of 3, and higher scores indicating greater irritability symptom severity. Parent participants will complete the ARI-P at baseline and Week 8.

  Baseline and Week 8

• Parent perception of change in child emotion regulation from baseline measured on GIS at Week 8

  Global Improvement Scale (GIS): The GIS is a parent self-report question that asks parents if they have noticed any overall improvements in their child's emotion regulation, with response options ranging from (1) very much improved to (7) very much worse. Minimum score = 1, Maximum score = 7, with higher numbers indicating less improvement, or worsening. The GIS has not been scientifically validated. Parent participants will complete the GIS at Week 8.

  Baseline and Week 8

Secondary Outcomes (3)

• Change in parent emotion regulation from baseline measured on DERS-18 at Week 8

  Baseline and Week 8

• Change in parent beliefs about intervention credibility and effectiveness from baseline, measured on the CEQ-P at Week 4 and Week 8

  Baseline, Week 4, and Week 8

• Change in child-parent relationship from baseline, measured on the CPRS-SF at Week 8

  Baseline and Week 8

Study Arms (2)

Mightier Child Play

ACTIVE COMPARATOR

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.

Behavioral: Mightier online gameplay

Mightier Child and Parent Play

EXPERIMENTAL

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.

Behavioral: Mightier online gameplay

Interventions

Mightier online gameplay BEHAVIORAL

Mightier is a video-game-based biofeedback intervention that capitalizes on children's love of video games to increase emotional awareness and facilitate emotion regulation practice through heart rate (HR) control. Each family receives a Mightier Kit (Mighty Band heart rate monitor, dedicated Mightier tablet unless the family prefers to use their own device) and the Mightier App. Children wear a "Mighty Band" heart rate monitor on their arm while they play any one of 26+ games. As their heart rate rises the games become more difficult. For example, during a cooking game, smoke may appear on the screen and obscure the player's view. Children can either opt into an explicit cool down activity (deep breathing, progressive muscle relaxation, crossing the midline, or visualization) or cool down on their own. By simply playing Mightier, children are motivated to practice calming strategies in moments of challenge.

Also known as: Mightier

Mightier Child Play; Mightier Child and Parent Play

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Neuromotion Labs: lead

Study Sites (1)

Neuromotion Labs

Boston, Massachusetts, 02111, United States

Location

Related Publications (5)

• RC Pianta - Unpublished measure, University of Virginia, 1992

  BACKGROUND

• Stringaris A, Goodman R, Ferdinando S, Razdan V, Muhrer E, Leibenluft E, Brotman MA. The Affective Reactivity Index: a concise irritability scale for clinical and research settings. J Child Psychol Psychiatry. 2012 Nov;53(11):1109-17. doi: 10.1111/j.1469-7610.2012.02561.x. Epub 2012 May 10.

  PMID: 22574736 BACKGROUND

• Weisz JR, Vaughn-Coaxum RA, Evans SC, Thomassin K, Hersh J, Ng MY, Lau N, Lee EH, Raftery-Helmer JN, Mair P. Efficient Monitoring of Treatment Response during Youth Psychotherapy: The Behavior and Feelings Survey. J Clin Child Adolesc Psychol. 2020 Nov-Dec;49(6):737-751. doi: 10.1080/15374416.2018.1547973. Epub 2019 Jan 18.

  PMID: 30657721 BACKGROUND

• Nock, M.K., Ferriter, C. & Holmberg, E. Parent Beliefs about Treatment Credibility and Effectiveness: Assessment and Relation to Subsequent Treatment Participation. J Child Fam Stud 16, 27-38 (2007). https://doi.org/10.1007/s10826-006-9064-7

  BACKGROUND

• Victor, S.E., Klonsky, E.D. Validation of a Brief Version of the Difficulties in Emotion Regulation Scale (DERS-18) in Five Samples. J Psychopathol Behav Assess 38, 582-589 (2016). https://doi.org/10.1007/s10862-016-9547-9

  BACKGROUND

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 18, 2021
• Study Start: October 20, 2021
• Primary Completion: March 19, 2022
• Study Completion: June 7, 2022
• Last Updated: June 9, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)