Clinical trial NCT04839861: Examining the Impacts of Parent-Child Interactive Activities
Official title: Examining the Impacts of Parent-Child Interactive Activities as an Adjunct to Mightier Play
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Regulation
Lead sponsor: Neuromotion Labs
Sponsor class: INDUSTRY
First posted: 2021-04-09
Enrollment: 42
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: The purpose of this study is to demonstrate the effects of online and offline play of games on the Mightier game platform, in comparison to the effects of Mightier online play alone.

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.

Mightier will soon introduce offline Mightier Family Games to its product line. Mightier Family Games will include offline, interactive components that have not previously been incorporated into Mightier play. Studies have shown that improvements in child behavior and child-parent relationships are among the many benefits of family play.

For the proposed study, families with no prior Mightier exposure will engage in different types of Mightier play for six weeks, to demonstrate the effects of online and offline Mightier play in comparison to the effects of Mightier online play alone. Mightier will recruit families through social media, then Mightier will randomly assign participants to one of two groups: a Mightier online play only group, and a Mightier online and offline play group. The investigators will aim to enroll 20 participants in each group.

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 6-week study period

Primary outcomes:
measure: Change in child irritability from baseline measured on ARI-P at Week 7
timeFrame: Baseline and Week 7
measure: Change in child-parent relationship from baseline measured on CPRS-SF at Week 7
timeFrame: Baseline and Week 7
measure: Parent perception of change in child emotion regulation from baseline measured on GIS at Week 7
timeFrame: Week 7
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Neuromotion Labs
state: Massachusetts
Study officials:
affiliation: Neuromotion Labs Inc
name: Jason Kahn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: RC Pianta - Unpublished measure, University of Virginia, 1992