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Clinical Trials/NCT04732806
NCT04732806
Completed
N/A

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

Neuromotion Labs1 site in 1 country183 target enrollmentMarch 10, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Emotional Dysregulation
Sponsor
Neuromotion Labs
Enrollment
183
Locations
1
Primary Endpoint
Behavioral healthcare utilization cost
Status
Completed
Last Updated
6 months ago

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.

Registry
clinicaltrials.gov
Start Date
March 10, 2021
End Date
October 1, 2025
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Behavioral healthcare utilization cost

Time Frame: 12 Months

Dollars spent on behavioral healthcare over the study period.

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

Time Frame: Baseline, 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).

Secondary Outcomes

  • 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)
  • Clinical Global Impression - Improvement, Oppositional/Defiant Behavior (CGI-I Oppositional/Defiant Behavior)(3 months)
  • 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)
  • Clinical Global Impression - Improvement, Disruptive Behavior (CGI-I Disruptive Behavior)(3 months)
  • Change in Parent Confidence and Resources from baseline to 3 Months(Baseline, 3 months)
  • Change in NIH-Emotion Toolbox from baseline to 3 Months(Baseline, 3 months)

Study Sites (1)

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