Clinical trial NCT04732806: A Mightier Healthcare System
Official title: A Mightier Healthcare System: Introducing a Game-based Pediatric Mental Health Intervention Into Payor-sponsored Care to Evaluate Financial and Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Emotional Dysregulation
Lead sponsor: Neuromotion Labs
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
name: Magellan Healthcare
First posted: 2021-02-01
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Behavioral healthcare utilization cost
timeFrame: 12 Months
measure: Change in Modified Overt Aggression Scale (MOAS) from baseline to 3 Months
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in Disruptive Behavior Disorder Rating Scale (DBDRS) - Oppositional/Defiant Factor Score from baseline to 3 Months
timeFrame: Baseline, 3 months
measure: Change in Affective Reactivity Index - Parent (ARI-P) from baseline to 3 Months
timeFrame: Baseline, 3 months
measure: Change in Parent Stress Index - Short Form (PSI-SF) from baseline to 3 Months
timeFrame: Baseline, 3 months
measure: Clinical Global Impression - Improvement, Irritability/Anger (CGI-I Irritability/Anger)
timeFrame: 3 months
measure: Clinical Global Impression - Improvement, Aggression (CGI-I Aggression)
timeFrame: 3 months
measure: Clinical Global Impression - Improvement, Oppositional/Defiant Behavior (CGI-I Oppositional/Defiant Behavior)
timeFrame: 3 months
measure: Clinical Global Impression - Improvement, Disruptive Behavior (CGI-I Disruptive Behavior)
timeFrame: 3 months
measure: Change in Parent Confidence and Resources from baseline to 3 Months
timeFrame: Baseline, 3 months
measure: Change in NIH-Emotion Toolbox from baseline to 3 Months
timeFrame: Baseline, 3 months
Other outcomes:
measure: Customer Satisfaction
timeFrame: 3 months
measure: Net Promoter Score
timeFrame: 3 months
measure: Heart Rate
timeFrame: 1hz intervals when playing game for 6 months
measure: Change in Disruptive Behavior Disorder Rating Scale (DBDRS) - Total Score
timeFrame: Baseline, 3 Months
measure: Behavioral healthcare utilization cost -- billed as medical
timeFrame: 12 Months
Locations:
city: Boston
country: United States
facility: Neuromotion Inc
state: Massachusetts
Study officials:
References: