Clinical trial NCT05080647: Examining the Impacts of Parent Mightier Play
Official title: Examining the Impacts of Parent Mightier Play as a Supplement to Child Mightier Play
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Regulation
Lead sponsor: Neuromotion Labs
Sponsor class: INDUSTRY
First posted: 2021-10-18
Enrollment: 41
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: Mightier is a mobile app-based biofeedback video game platform that facilitates emotion regulation skill-building among children ages 6-14. The technology behind Mightier's mobile app has been validated in two independent sham-controlled randomized controlled trials, where the investigators have seen decreases in clinical symptoms of aggression and disruptive behaviors, as well as lowered family stress without adverse events.

The study utilizes a parallel randomized controlled design comparing groups of participant families whose children play Mightier video games without parent play to groups of participant families in which both children and parents play Mightier video games. Self-report measures will be completed by participant children and parents.

The study consists of three primary phases: Pre-Study, Active Engagement, and Follow-Up. During the Pre-Study Phase, participants will undergo pre-screening and screening to evaluate interest and eligibility for the study, and participants who consent to participate in the study will complete baseline measures and be randomized into treatment groups. Mightier games will be shipped to participants during or shortly after their Pre-Study call. Participants will be instructed to begin Mightier gameplay as soon as Mightier games arrive at their homes, which will begin the Active Engagement Phase of the study.

During the 8-week Active Engagement Phase, participants will be encouraged to play Mightier games in a way that corresponds to their study condition, and they will be offered engagement support in the form of brief weekly check-ins.

After completion of the Active phase, participants will have a brief Follow-up phase, consisting of one video call during which child and parent participants will complete self-report follow-up measures.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in child behavior and emotion problems measured on BFS at Week 8
timeFrame: Baseline and Week 8
measure: Change in child irritability from baseline measured on ARI-P at Week 8
timeFrame: Baseline and Week 8
measure: Parent perception of change in child emotion regulation from baseline measured on GIS at Week 8
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change in parent emotion regulation from baseline measured on DERS-18 at Week 8
timeFrame: Baseline and Week 8
measure: Change in parent beliefs about intervention credibility and effectiveness from baseline, measured on the CEQ-P at Week 4 and Week 8
timeFrame: Baseline, Week 4, and Week 8
measure: Change in child-parent relationship from baseline, measured on the CPRS-SF at Week 8
timeFrame: Baseline and Week 8
Other outcomes:
Locations:
city: Boston
country: United States
facility: Neuromotion Labs
state: Massachusetts
Study officials:
References:
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citation: 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
citation: Bjureberg J, Ljotsson B, Tull MT, Hedman E, Sahlin H, Lundh LG, Bjarehed J, DiLillo D, Messman-Moore T, Gumpert CH, Gratz KL. Development and Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16. J Psychopathol Behav Assess. 2016 Jun;38(2):284-296. doi: 10.1007/s10862-015-9514-x. Epub 2015 Sep 14.