A Mightier Healthcare System

NCT ID: NCT04732806

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-10
• Study Completion Date: 2025-10-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Treatment as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Six months of ad lib Mightier play in home

Group Type: EXPERIMENTAL

Mightier video games

Intervention Type: BEHAVIORAL

Biofeedback video game play in home

Interventions

Mightier video games

Biofeedback video game play in home

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion:

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Magellan Healthcare

UNKNOWN

Sponsor Role: collaborator

Neuromotion Labs

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Neuromotion Inc

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

1R44MH124574-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NML-2020-001

Identifier Type: -

Identifier Source: org_study_id