A Mightier Healthcare System

Neuromotion Labs

Status

Enrolling

Conditions

Emotional Dysregulation

Treatments

Behavioral: Mightier video games

Study type

Interventional

Funder types

Industry

Other

NIH

Identifiers

NCT04732806

NML-2020-001

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

8 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

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