Examining the Impacts of Parent-Child Interactive Activities

Neuromotion Labs

Status: Completed

Conditions: Emotional Regulation

Treatments: Behavioral: Mightier online gameplay; Behavioral: Mightier Family Games

Study type: Interventional

Funder types: Industry

Identifiers

NCT04839861

874MIGH21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

42 participants in 2 patient groups

Mightier Online Games

Active Comparator group

Description:

6 weeks of use ad-libitum. Parents will be encouraged to have their children play Mightier online games at least 3 times a week for the 6 week duration.

Treatment:

Behavioral: Mightier online gameplay

Mightier Online Plus Offline Family Games

Experimental group

Description:

6 weeks of use ad-libitum. Parents will be encouraged to have their children play Mightier online games at least 3 times a week for the 6 week duration. Parents will be encouraged to play Mightier offline Family Games at least once a week for the 6 week duration.

Treatment:

Behavioral: Mightier Family Games

Behavioral: Mightier online gameplay