A Mightier Healthcare System

NCT04732806 | Completed

• 2 other identifiers: NML-2020-0011R44MH124574-01
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

Access to effective pediatric mental health treatment is a major public health concern in the United States as paucity of pediatric providers leading to long wait times, financial burden, and stigma pose significant barriers to treatment. Digital mental health promises to remedy many chronic problems faced in providing timely and accessible mental health interventions to children. With that in mind, the investigators and Neuromotion Inc. created Mightier, an app-based heart rate biofeedback videogame platform designed to teach and facilitate practice of emotional regulation skills. The technology behind Mightier is backed by three trials showing clinical efficacy and since commercial launch 75% of families who have engaged with the product report improvement. However, Neuromotion's core mission remains increasing access to care, and the direct-to-consumer distribution of digital health also faces access challenges. The investigators propose that access to effective digital mental health interventions can be increased by meeting families where they already know to seek care: the traditional healthcare system. The investigators have partnered with a nationwide behavioral health insurance provider to pilot the integration of Mightier with traditional healthcare. Families will be recruited via direct outreach, social media, or healthcare provider referral. Participating children will be randomized into Mightier or treatment as usual control groups for 6 months. Behavioral healthcare utilization will be observed for 12 months. Through this work the investigators will demonstrate the value of Mightier to various stakeholders via decreased long-term healthcare utilization, confirm that Mightier use results in decreased symptoms of emotional dysregulation, irritability, and parent stress, and explore relationships among Mightier use, healthcare utilization, and symptoms. Ultimately this work will pave the way forward for large scale integration of digital healthcare and more traditional healthcare avenues while simultaneously increasing Mightier's ability to reach children in need.

Conditions

Emotional Dysregulation

Outcome Measures

Primary Outcomes (2)

• Behavioral healthcare utilization cost

  Dollars spent on behavioral healthcare over the study period.

  12 Months

• Change in Modified Overt Aggression Scale (MOAS) from baseline to 3 Months

  The MOAS is a 5-point parent rated scale that rates the severity of four types of aggression: verbal, against property, against self (auto-aggression), and physical towards others. Scores range from 0-100 with lower scores representing less aggression (better outcome).

  Baseline, 3 months

Secondary Outcomes (9)

• Change in Disruptive Behavior Disorder Rating Scale (DBDRS) - Oppositional/Defiant Factor Score from baseline to 3 Months

  Baseline, 3 months

• Change in Affective Reactivity Index - Parent (ARI-P) from baseline to 3 Months

  Baseline, 3 months

• Change in Parent Stress Index - Short Form (PSI-SF) from baseline to 3 Months

  Baseline, 3 months

• Clinical Global Impression - Improvement, Irritability/Anger (CGI-I Irritability/Anger)

  3 months

• Clinical Global Impression - Improvement, Aggression (CGI-I Aggression)

  3 months

Other Outcomes (5)

• Customer Satisfaction

  3 months

• Net Promoter Score

  3 months

• Heart Rate

  1hz intervals when playing game for 6 months

Study Arms (2)

Treatment as usual

NO INTERVENTION

Intervention

EXPERIMENTAL

Six months of ad lib Mightier play in home

Behavioral: Mightier video games

Interventions

Mightier video games BEHAVIORAL

Biofeedback video game play in home

Intervention

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 8-12
• Insurance provided by Magellan Healthcare OR participant is covered by insurance in Massachusetts and has access to Explanation of Benefits information via online portal
• Has made a behavioral health claim in the past year
• MOAS score of greater than or equal to 2
• Evidence of ADHD, ODD, CD, DMDD, IED, or ASD by MINI-KID
• Parent or guardian is fluent in English
• WiFi at home (for Mightier tablet connection)
• Access to a computer or tablet in the home

You may not qualify if:

• IQ \< 70 (by medical record or clinician judgment)
• Extremely limited verbal capacity
• Change in medication or medication dosage in the past month or planned change in medication or medication dosage in the next month
• Active suicidal ideation
• History of suicide attempt and current depression
• Physical limitations that preclude the use of Mightier
• Sensory sensitivities that would preclude wearing an arm (or leg) heart rate monitor
• Evidence of psychosis, mania, alcohol use disorder, substance use disorder, or PTSD by MINI-Kid
• Ongoing or within the month prior to baseline visit placement in foster care or residential facility

Sponsors & Collaborators

• Neuromotion Labs: lead
• National Institute of Mental Health (NIMH): collaborator
• Magellan Healthcare: collaborator

Study Sites (1)

Neuromotion Inc

Boston, Massachusetts, 02110, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 1, 2021
• Study Start: March 10, 2021
• Primary Completion: November 23, 2022
• Study Completion: October 1, 2025
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)