- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04732806
A Mightier Healthcare System
December 20, 2022 updated by: Neuromotion Labs
A Mightier Healthcare System: Introducing a Game-based Pediatric Mental Health Intervention Into Payor-sponsored Care to Evaluate Financial and Clinical Outcomes
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jason Kahn, PhD
- Phone Number: 888-978-7495
- Email: jason@mightier.com
Study Contact Backup
- Name: Alyssa Peechatka, PhD
- Phone Number: 888-978-7495
- Email: alyssa@mightier.com
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02110
- Recruiting
- Neuromotion Inc
-
Contact:
- Jason Kahn, PhD
- Email: jason@mightier.com
-
Contact:
- Alyssa Peechatka, PhD
- Email: alyssa@mightier.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Treatment as usual
|
|
Experimental: Intervention
Six months of ad lib Mightier play in home
|
Biofeedback video game play in home
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioral healthcare utilization cost
Time Frame: 12 Months
|
Dollars spent on behavioral healthcare over the study period.
|
12 Months
|
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).
|
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
Time Frame: Baseline, 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
Time Frame: Baseline, 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
Time Frame: Baseline, 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)
Time Frame: 3 months
|
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)
Time Frame: 3 months
|
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)
Time Frame: 3 months
|
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)
Time Frame: 3 months
|
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
Time Frame: Baseline, 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
Time Frame: Baseline, 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Customer Satisfaction
Time Frame: 3 months
|
Evaluated in the Mightier group only.
Customer satisfaction will be rated using a single, parent/guardian response item.
Response options will be extremely dissatisfied, somewhat dissatisfied, neither satisfied not dissatisfied, somewhat satisfied, or extremely satisfied.
|
3 months
|
Net Promoter Score
Time Frame: 3 months
|
Evaluated in the Mightier group only.
Net Promotor Score represents the industry standard for evaluating customer willingness to recommend a product.
The rating consists of a single parent/guardian report item with responses options ranging from 0 (not at all likely) to 10 (extremely likely).
When scores are aggregated, Net Promoter Score is expressed as the percentage of customers who rated their likelihood to recommend the product as 9 or 10 minus the percentage of customers rating this at 6 or below.
|
3 months
|
Heart Rate
Time Frame: 1hz intervals when playing game for 6 months
|
1hz intervals when playing game for 6 months
|
|
Change in Disruptive Behavior Disorder Rating Scale (DBDRS) - Total Score
Time Frame: Baseline, 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).
|
Baseline, 3 Months
|
Behavioral healthcare utilization cost -- billed as medical
Time Frame: 12 Months
|
Dollars spent on healthcare billed as medical cost, but related to behavioral or mental health indications, over the study period
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2021
Primary Completion (Anticipated)
June 30, 2024
Study Completion (Anticipated)
June 30, 2024
Study Registration Dates
First Submitted
January 25, 2021
First Submitted That Met QC Criteria
January 28, 2021
First Posted (Actual)
February 1, 2021
Study Record Updates
Last Update Posted (Actual)
December 21, 2022
Last Update Submitted That Met QC Criteria
December 20, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- NML-2020-001
- 1R44MH124574-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Emotional Dysregulation
-
Karolinska InstitutetTerminatedEmotional DysregulationSweden
-
Consorci Sanitari del MaresmeUniversity Ramon LlullNot yet recruitingEmotional Dysregulation
-
Soroka University Medical CenterUnknownEmotional Dysregulation | Dialectical Behavioral TherapyIsrael
-
IRCCS Centro San Giovanni di Dio FatebenefratelliCompletedEmotional DysregulationItaly
-
Duke UniversityNational Institute of Mental Health (NIMH)RecruitingMood Disorders | Obsessive-Compulsive Disorder | Anxiety Disorders | OCD | Borderline Personality Disorder | Stress Disorder | Emotional Distress | Emotion Regulation | Eating Disorders | Emotion Dysregulation | Emotional Dysfunction | Emotional Impulsivity | Emotional Instability | Impulse Control Disorder | Emotional...United States
-
Icahn School of Medicine at Mount SinaiCompletedTraumatic Brain Injury | Executive Dysfunction | Emotional DysregulationUnited States
-
Centre Hospitalier Universitaire de BesanconCompleted
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)CompletedSevere Mood DysregulationUnited States
-
University Hospital, Basel, SwitzerlandCompletedPrimary Vascular DysregulationSwitzerland
-
Federal University of Rio Grande do SulUnknownSevere Mood DysregulationBrazil
Clinical Trials on Mightier video games
-
Neuromotion LabsCompleted
-
University of PittsburghNational Library of Medicine (NLM)Completed
-
Shalvata Mental Health CenterCompletedDepression | Anxiety | ADHD | PDD | ConductIsrael
-
St. Justine's HospitalCanadian Institutes of Health Research (CIHR); Concordia University, MontrealCompleted
-
Universiti Putra MalaysiaRecruitingBody Weight Changes | Physical Inactivity | Mental Health IssueChina
-
Universidad de ZaragozaCompletedPhysical Activity | Sedentary Lifestyle | Childhood Obesity | Body FatSpain
-
Abant Izzet Baysal UniversityCompletedBody Weight | Self-Perception
-
The University of Texas Medical Branch, GalvestonCompleted
-
Ohio State UniversityCompletedPsychology, Social | Adolescent BehaviorUnited States
-
Medipol UniversityCompleted