Clinical trial NCT05652114: Open Label Mightier Play in the Home
Official title: Examining the Impact of Mightier Play on Common Pediatric Symptoms in an Uncontrolled Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Regulation
Lead sponsor: Neuromotion Labs
Sponsor class: INDUSTRY
First posted: 2022-12-15
Enrollment: 2732
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: As a single arm study all participants' children will receive a game-based biofeedback intervention. They are encouraged to engage with the intervention in an entirely self-directed manner.
Primary purpose: TREATMENT

Brief summary: Mightier is a digital mental health tool that uses video game-based heart rate biofeedback to teach emotion regulation. The primary goal of this study is to replicate results from original clinical trials, demonstrating that playing Mightier at home improves common symptoms associated with emotional dysregulation.

Participants will be caregivers of children who are using Mightier, a video-game based heart rate biofeedback intervention. Caregivers will be asked to complete a short survey about their child's emotions and behaviors prior to their child's first play and then complete that survey two more times, at 8 weeks and 12 weeks post baseline.

The pre-post self report design will allow us to observe changes during Mightier use and relate those changes to overall engagement with the intervention

Detailed description: 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 and dedicated tablet), the Mightier App, online caregiver resources, and dedicated 1-on-1 support from a licensed clinician. The effectiveness of Mightier has been supported through several studies in children ages 8-18, specifically reducing symptoms of aggression, oppositional behavior, and parental stress. The core hypothesis underlying Mightier is that learning to regulate autonomic arousal via HR regulation during gameplay will lead to greater emotional regulation capacity. This hypothesis has considerable support, as greater dynamic HR control is associated with greater emotional clarity, emotion regulation, and impulse control in both adults and children.

Although originally created and studied in an academic medical center, it is not well understood how these learnings translate to change in a more diverse population in a less well-controlled environment (i.e. the home) with varying engagement with the intervention. Increased understanding of the Mightier population's behavioral and symptom characteristics, and the interplay between individual characteristics, engagement, HR, and symptom change is imperative to improving the intervention.

For this proposed study, we hypothesize the following:

1. Participants will report reduction in symptoms after 12 weeks of Mightier
2. Participants will show reduction in median HR during gameplay after 12 weeks of Mightier

   a. The magnitude of this change will be greater in externalizing symptoms
3. Change in symptoms will be inversely associated with total playtime such that children who play Mightier more will see the largest change (i.e. reduction) in symptoms
4. Changes in symptoms will be associated with change in median HR during gameplay, such that larger reductions in symptoms will be associated with larger reductions in HR during gameplay

After consent is obtained, caregivers will begin the survey. They will first be asked to identify whether symptoms associated with Anxiety, Attention Deficit Hyperactivity Disorder (ADHD), irritability, or aggression best describe their child. Based on these responses, caregivers will be asked to complete one of four validated symptom questionnaires. Those who indicated symptoms of anxiety best describe their child will complete the SCARED, a 41 item measure of symptoms of Anxiety related disorders. Those who indicated symptoms of ADHD best describe their child will complete the NICHQ Vanderbilt Assessment Scale, a 55 item measure of symptoms and ratings of functional performance associated with ADHD and Oppositional Defiant Disorder. Those who indicated aggression and aggressive behaviors best describe their child will complete the MOAS, a 4 item measure of verbal aggression, physical aggression, aggression against property, and autoaggression. Finally, those who indicated that symptoms of irritability best describe their child will complete the ARI a 7 item measure of irritability. Upon completion of the respective scale, caretakers will be thanked and informed that they will be contacted in approximately 8-12 weeks.

For the duration of the 8-12 week intervention period, participants will play Mightier ad libitum.

Eligibility criteria: Inclusion Criteria:

* Parent or caregivers have a child engaging with the heart rate biofeedback intervention Mightier

Exclusion Criteria:

* None

Primary outcomes:
measure: Affective Reactivity Index - Parent
timeFrame: 12 weeks
measure: Modified Overt Aggression Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Screen for Anxiety Related Emotional Disorders
timeFrame: 12 weeks
measure: National Institute for Children's Health Quality Vanderbilt Assessment Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Neuromotion Inc
state: Massachusetts
Study officials:
References: