A Mightier Healthcare System

Study Overview
=================
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.

Official Title
-----------------
A Mightier Healthcare System: Introducing a Game-based Pediatric Mental Health Intervention Into Payor-sponsored Care to Evaluate Financial and Clinical Outcomes

Conditions
-----------------
Emotional Dysregulation

Intervention / Treatment
-----------------
* Behavioral: Mightier video games


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as usual<br> | |
| Experimental: Intervention<br>Six months of ad lib Mightier play in home | Behavioral: Mightier video games<br>* Biofeedback video game play in home<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Disruptive Behavior Disorder Rating Scale (DBDRS) - Oppositional/Defiant Factor Score from baseline to 3 Months | The DBDRS is a 45-item scale that evaluates symptoms of Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), and Attention Deficit Hyperactivity Disorder (ADHD) from the parent's perspective. Scores range from 0-135 with lower scores representing fewer behaviors associated with the above disorders (better outcome). This secondary outcome will include the Oppositional/Defiant Factor Score consisting of items 3, 13, 15, 17, 24, 26, 28, and 39. | Baseline, 3 months | 
| Change in Affective Reactivity Index - Parent (ARI-P) from baseline to 3 Months | The ARI is a 7-item scale that consists of 6 symptom items and 1 impairment item. The scale was designed to determine irritable mood rather than behavioral consequences such as hostility and acts of aggression. Scores range from 0 - 12 with lower scores representing less irritability. | Baseline, 3 months | 
| Change in Parent Stress Index - Short Form (PSI-SF) from baseline to 3 Months | The PSI-SF is a 36 item parent report scale that evaluates the extent and source of parent stress in the form of three subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Total scores range from 36-180 with lower scores representing less parent stress. | Baseline, 3 months | 
| Clinical Global Impression - Improvement, Irritability/Anger (CGI-I Irritability/Anger) | The CGI-I scale requires the clinician to rate total improvement whether or not, in the raters judgment, it is due to treatment. The clinician compares the patient's condition at baseline to the time of rating on a scale ranging from 1 (very much improved) to 7 (very much worse) | 3 months | 
| Clinical Global Impression - Improvement, Aggression (CGI-I Aggression) | The CGI-I scale requires the clinician to rate total improvement whether or not, in the raters judgment, it is due to treatment. The clinician compares the patient's condition at baseline to the time of rating on a scale ranging from 1 (very much improved) to 7 (very much worse) | 3 months | 
| Clinical Global Impression - Improvement, Oppositional/Defiant Behavior (CGI-I Oppositional/Defiant Behavior) | The CGI-I scale requires the clinician to rate total improvement whether or not, in the raters judgment, it is due to treatment. The clinician compares the patient's condition at baseline to the time of rating on a scale ranging from 1 (very much improved) to 7 (very much worse) | 3 months | 
| Clinical Global Impression - Improvement, Disruptive Behavior (CGI-I Disruptive Behavior) | The CGI-I scale requires the clinician to rate total improvement whether or not, in the raters judgment, it is due to treatment. The clinician compares the patient's condition at baseline to the time of rating on a scale ranging from 1 (very much improved) to 7 (very much worse) | 3 months | 
| Change in Parent Confidence and Resources from baseline to 3 Months | Two 5 item questions regarding parent confidence in their ability to manage their child's behaviors and adequacy of resources to manage their child's behaviors | Baseline, 3 months | 
| Change in NIH-Emotion Toolbox from baseline to 3 Months | The NIH toolbox for emotion was developed to create a standardized, comprehensive, and concise battery of tests that can recognize the full spectrum of emotional experiences and their impacts on health and wellbeing. The NIH Toolbox for emotion includes 4 subdomains: negative affect, psychological well-being, stress and self-efficacy, and social relationships. For the age range of 8-12, self-report and proxy measures are available. Given that we expect a wide range of cognitive, developmental, and metacognitive abilities, proxy report measures will be used. | Baseline, 3 months |