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

NCT ID: NCT05260398

Last Updated: 2022-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2022-12-31

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. 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. 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.

Detailed Description

Study Design:

A randomized controlled trial comparing pre- and post-measures for a group in which child participants play Mightier video games for the active 8-week study period (Mightier Now group) to a group in which child participants wait during the active 8-week study period, then play Mightier after post-measures are collected (Mightier Later group).

Study Sample:

40 parent-child dyads in which the enrolled children are between 6 and 11 years old, have no prior Mightier experience, and attend school outside the home; 40 school teacher informants, who will complete baseline and follow-up measures on behalf of enrolled children.

Study Aims:

Aim 1. Demonstrate that children's in-home Mightier play is associated with reduced in-school emotional and behavioral problems. The investigators hypothesize that teachers will report reductions in child participants' school emotional and behavioral challenges after 8 weeks of child Mightier gameplay at home.

Aim 2. Demonstrate that children's in-home Mightier play is associated with parent-perceived reductions in child emotional and behavioral challenges and overall improvements in child emotion regulation. The investigators hypothesize that parents will report reductions in child participants' emotional and behavioral challenges and improvements in child emotion regulation after 8 weeks of child Mightier gameplay.

Recruitment Participants will be recruited to the study via social media ads, emails to families who have inquired about Mightier research studies, and clinician and educator referrals.

Screening Families who are interested in enrolling in the study will complete screening via an online questionnaire form to screen for inclusion and exclusion criteria.

During study screening, families will be given a link to share with their child's school teacher, along with sample language that families can use to inform the teacher that the family would like to participate in a research study, that the study requires data at baseline and Week 8 from questionnaires completed by a teacher who sees the student regularly.

Teachers who use the link provided by families who are interested in the study will link to a web page providing information about the research study and asking is the teacher is willing and able to complete study measures.

If children meet inclusion/exclusion criteria and teachers are willing and able to complete questionnaires, then parents/guardians and child participants will be invited to schedule a video call to complete study informed consent and assent forms.

Baseline data collection Parents and teachers will complete baseline questionnaires via online form.

Randomization After baseline questionnaires for a child participant are completed by parent and teacher, the child's family will be randomly assigned to the Mightier Now study cohort or the Mightier Later study cohort.

Before enrollment starts, a randomization list 60 subjects long will be created. Participants will be assigned to groups per this list, in the same order in which participants enroll in the study.

Intervention Families in the Mightier Now cohort will receive a Mightier shipment via UPS and will be directed to encourage child participants to play Mightier in their homes on an ad lib basis for eight weeks. Families in the Mightier Later cohort will be advised that their Mightier shipment will arrive after Week 8 questionnaires have been completed by a parent and teacher of the child participant.

Study check-ins Research staff will check in with families at weeks 0, 2, 4, and 6 of the study.

Study check-ins will consist of:

An email from research staff acknowledging child cumulative Mightier play minutes and encouraging ongoing play, Mightier gameplay engagement support, and links for scheduling study phone calls or zoom calls, at the discretion and preference of study participants.

Safety monitoring Participant safety will be assessed at study visits. Adverse events will be monitored and recorded. Concerns about participant safety will be reviewed by a clinician-on-call, a licensed clinical social worker, who will aid with referrals to local authorities as necessary.

Follow-up data collection Parents and teachers will complete follow-up questionnaires via online form as close as possible to 8 weeks after start of play.

Duration of treatment:

8 weeks of use ad-libitum. Parents in the Mightier Now study cohort will be encouraged to have their children play Mightier games at least 3 times a week / at least 45 minutes per week of Mightier play for the 8 week duration.

Parents in the Mightier Later study cohort will be reminded that they are in a "wait list" cohort, and that their Mightier shipment will arrive after parents and teachers complete the baseline and follow-up questionnaires.

Conditions

Emotional Regulation; Problem Behavior; Irritable Mood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mightier Now

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.

Group Type: EXPERIMENTAL

Mightier Online Gameplay

Intervention Type: 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 Later

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mightier Online Gameplay

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Neuromotion Labs

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Neuromotion Labs

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 34539455 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 22574736 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

1076MIGH22

Identifier Type: -

Identifier Source: org_study_id