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NCT04732806 · ClinicalTrials.gov registry record · NA
A Mightier Healthcare System
A NA study of Emotional Dysregulation, sponsored by Neuromotion Labs.
- Completed
- Registry status
- NA
- Development phase
- 183
- Enrollment target
- 1
- Study location
NCT04732806: Completed NA study of Emotional Dysregulation, sponsored by Neuromotion Labs.
NCT04732806 is a NA study of Emotional Dysregulation that has completed, run by Neuromotion Labs. The registered enrollment target is 183 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04732806, a NA study of Emotional Dysregulation, has completed, sponsored by Neuromotion Labs.
- COMPLETED
- Registry status
- NA
- Development phase
- 183 participants
- Enrollment target
- 1
- Study location
Study 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 mor
Primary Outcome
Dollars spent on behavioral healthcare over the study period.
Conditions Studied
Interventions
- BEHAVIORAL Mightier video games
Study Locations (1)
Massachusetts
- Neuromotion Inc - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2021-03-10 |
| Est. Completion | 2025-10-01 |
| Phase | NA |
What the finished NCT04732806 record still lists
NCT04732806 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Emotional Dysregulation appearing as the primary indexed condition, and to 1 intervention - of which Mightier video games is the first listed.
NCT04732806 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04732806 about?
NCT04732806 is a clinical study titled "A Mightier Healthcare System". 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 problem...
What is the current status of trial NCT04732806?
This trial is currently completed. It is a NA study. The enrollment target is 183 participants. The study started on 2021-03-10. Estimated completion is 2025-10-01.
What conditions does trial NCT04732806 study?
This clinical trial studies the following conditions: Emotional Dysregulation.
What interventions are being tested in trial NCT04732806?
The interventions under investigation include: Mightier video games (BEHAVIORAL).
Who is sponsoring clinical trial NCT04732806?
This trial is sponsored by Neuromotion Labs, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04732806 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04732806's enrollment target sits among peer trials
183 584th of 2000 higher than 1,417 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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