Status:
COMPLETED
A Mightier Healthcare System
Lead Sponsor:
Neuromotion Labs
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Magellan Healthcare
Conditions:
Emotional Dysregulation
Eligibility:
All Genders
8-12 years
Phase:
NA
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 p...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT04732806
Start Date
March 10 2021
End Date
October 1 2025
Last Update
October 22 2025
Active Locations (1)
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1
Neuromotion Inc
Boston, Massachusetts, United States, 02110