Examining the Impacts on In-School Behaviors of In-Home Videogame Play

NCT05260398 | Unknown

• 1 other identifier: 1076MIGH22
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study aims to investigate the effects of children's in-home engagement with a biofeedback video game-based intervention on children's in-school behaviors. For the proposed study, families with no prior Mightier exposure will engage in online gameplay for eight weeks. Mightier will recruit families through social media and clinical settings, then Mightier will randomly assign participants to one of two groups: a group in which the child participant is encouraged to play Mightier games with biofeedback elements 45 or more minutes a week, broken into 3 or more sessions a week soon after baseline data have been collected, and a group in which the child participant receives Mightier and is invited to play Mightier games with biofeedback elements after all study baseline and follow-up data have been collected. The investigators will aim to enroll 20 parent-child dyads in each group. Specific Aims and Hypotheses:

1. 1.Demonstrate that child engagement in Mightier biofeedback video games is correlated to child improvement in school behaviors. The investigators hypothesize that teachers of child participants will report reductions in child school behavior challenges after 8 weeks of child Mightier gameplay.
2. 2.Demonstrate that child engagement in Mightier biofeedback video games is correlated to child improvement in at-home behaviors and general improvement in emotion regulation. The investigators hypothesize that parents of child participants will report a reduction in child behavior challenges and improvements in child emotion regulation after 8 weeks of child Mightier gameplay.

Conditions

Emotional Regulation; Problem Behavior; Irritable Mood

Outcome Measures

Primary Outcomes (5)

• Change in in-school problem behaviors from baseline to follow-up

  Child Behavior Checklist- Teacher Report Form (CBCL-TRF): The CBCL-TRF (Achenbach \& Rescorla, 2001) assesses child adaptive behaviors and problem behaviors. There are 112 items that assess problem behaviors and 16 items that assess academic performance and adaptive behavior. School teachers of child participants will complete the CBCL-TRF at baseline and Week 8.

  Baseline and Week 8

• Change in in-home problem behaviors from baseline to follow-up

  Child Behavior Checklist (CBCL/6-18): The CBCL/6-18 (Achenbach \& Rescorla, 2001) assesses child adaptive behaviors and problem behaviors. There are 112 items that assess problem behaviors and 20 items that assess adaptive behavior. Response format for problem behaviors is from 0 ("not true") to 2 ("very true"). Parent participants will complete the CBCL/6-18 at baseline and follow-up.

  Baseline and Week 8

• Change in irritable mood from baseline to follow-up

  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

• Overall emotional regulation improvement as reported by teacher

  Clinical Global Impressions Scale Improvement Question (CGI-I): The CGI is a self-report question that asks the respondent if they have noticed any overall improvements in the child's emotion regulation, with response options ranging from (1) very much improved to (7) very much worse. The Teacher CGI-I has not been scientifically validated for use in research studies. Teachers of child participants will complete the CGI-I at follow-up.

  Week 8

• Overall emotional regulation improvement as reported by parent

  Clinical Global Impressions Scale Improvement Question (CGI-I): The CGI is a self-report question that asks the respondent if they have noticed any overall improvements in the child's emotion regulation, with response options ranging from (1) very much improved to (7) very much worse. The Parent CGI-I has not been scientifically validated for use in research studies. Parents of child participants will complete the CGI-I at follow-up.

  Week 8

Study Arms (2)

Mightier Now

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.

Behavioral: Mightier Online Gameplay

Mightier Later

NO INTERVENTION

8 weeks of wait list. Families in the Mightier Later condition will receive their Mightier shipment and will be encouraged to play Mightier after follow-up questionnaires have been completed 8 weeks after parents and teachers complete baseline questionnaires.

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.

Mightier Now

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 6-11 at the time of screening
• Attending school outside of the home and not planning to change schools or classrooms during the 8-week study period

You may not qualify if:

• Prior Mightier use
• Out-of-home School Teacher unable to complete baseline and follow-up questionnaires
• Planned medication changes during the 8-week study period
• Parents encouraged to self-exclude if their children have severe skin sensitivities
• Parents encouraged to self-exclude if their children are pre-readers

Sponsors & Collaborators

• Neuromotion Labs: lead

Study Sites (1)

Neuromotion Labs

Boston, Massachusetts, 02111, United States

Location

Related Publications (4)

• Ducharme P, Kahn J, Vaudreuil C, Gusman M, Waber D, Ross A, Rotenberg A, Rober A, Kimball K, Peechatka AL, Gonzalez-Heydrich J. A "Proof of Concept" Randomized Controlled Trial of a Video Game Requiring Emotional Regulation to Augment Anger Control Training. Front Psychiatry. 2021 Sep 1;12:591906. doi: 10.3389/fpsyt.2021.591906. eCollection 2021.

  PMID: 34539455 BACKGROUND

• Achenbach, T. M., & Rescorla, L. A. (2001). Manual for the ASEBA School-Age Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families.

  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

• Guy, WBRR (1976). CGI. Clinical global impressions. ECDEU assessment manual for psychopharmacology.

  BACKGROUND

MeSH Terms

Conditions

Emotional Regulation; Problem Behavior

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Behavioral Symptoms; Child Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Enrolled family random study cohort assignment will be masked from school teachers, who will complete outcome measure questionnaires about enrolled child participants at baseline and follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: March 2, 2022
• Study Start: February 28, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)