An app-based game to help children manage emotions
A Mightier Healthcare System: Introducing a Game-based Pediatric Mental Health Intervention Into Payor-sponsored Care to Evaluate Financial and Clinical Outcomes
This study tests a fun app-based game that helps kids aged 8-12 learn to manage their emotions better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 8 Years to 12 Years |
| Sex | All |
| Sponsor | Neuromotion Labs Industry-sponsored |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04732806 on ClinicalTrials.gov |
What this trial studies
This study evaluates Mightier, an app-based heart rate biofeedback video game designed to teach emotional regulation skills to children aged 8-12. The intervention aims to address the significant barriers to pediatric mental health treatment, such as long wait times and stigma, by providing accessible digital mental health solutions. Participants must have a behavioral health claim in the past year and meet specific eligibility criteria, including evidence of certain behavioral disorders. The study is conducted in collaboration with Neuromotion Labs and the National Institute of Mental Health.
Who should consider this trial
Good fit: Ideal candidates are children aged 8-12 with behavioral health issues such as ADHD or ODD, who have access to specific insurance and technology.
Not a fit: Patients with severe mental health issues, such as active suicidal ideation or psychosis, may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve emotional regulation skills in children, leading to better mental health outcomes.
How similar studies have performed: Previous trials have shown clinical efficacy for similar digital mental health interventions, indicating a promising approach.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Boston, Massachusetts
- Neuromotion Inc — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Jason Kahn, PhD
- Email: jason@mightier.com
- Phone: 888-978-7495
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.