Emotional DysregulationNCT04732806
A Mightier Healthcare System
A study testing Mightier video games in people with Emotional Dysregulation, run by Neuromotion Labs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Emotional Dysregulation
- What is being tested?
- Mightier video games
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2021to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Emotional Dysregulation
- Being tested
- Mightier video games
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mightier video gamesBehavioural
Biofeedback video game play in home
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | Not described |
| Intervention | Experimental | Six months of ad lib Mightier play in home Receives: Behavioral: Mightier video games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral healthcare utilization cost
Dollars spent on behavioral healthcare over the study period.
Measured: 12 Months
Change in Modified Overt Aggression Scale (MOAS) from baseline to 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).
Measured: Baseline, 3 months
Secondary outcomes (9)
Change in Disruptive Behavior Disorder Rating Scale (DBDRS) - Oppositional/Defiant Factor Score from baseline to 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.
Measured: Baseline, 3 months
Change in Affective Reactivity Index - Parent (ARI-P) from baseline to 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.
Measured: Baseline, 3 months
Change in Parent Stress Index - Short Form (PSI-SF) from baseline to 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.
Measured: Baseline, 3 months
Clinical Global Impression - Improvement, Irritability/Anger (CGI-I Irritability/Anger)
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)
Measured: 3 months
Clinical Global Impression - Improvement, Aggression (CGI-I Aggression)
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)
Measured: 3 months
Clinical Global Impression - Improvement, Oppositional/Defiant Behavior (CGI-I Oppositional/Defiant Behavior)
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)
Measured: 3 months
Clinical Global Impression - Improvement, Disruptive Behavior (CGI-I Disruptive Behavior)
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)
Measured: 3 months
Change in Parent Confidence and Resources from baseline to 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
Measured: Baseline, 3 months
Change in NIH-Emotion Toolbox from baseline to 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.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start10 Mar 2021
- Primary completion23 Nov 2022
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DysregulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuromotion Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), Magellan Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732806
- Sponsor's protocol ID
- NML-2020-001
- Other IDs
- 1R44MH124574-01
- Status last verified
- Oct 2025
- First submitted
- 25 Jan 2021
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mightier Healthcare System: Introducing a Game-based Pediatric Mental Health Intervention Into Payor-sponsored Care to Evaluate Financial and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT04732806
- Acronym / sponsor ID
- NML-2020-001
- Conditions
- Emotional Dysregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Neuromotion LabsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), Magellan Healthcare
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | – |
| Intervention | Experimental | Behavioral: Mightier video gamesSix months of ad lib Mightier play in home |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mightier video gamesBiofeedback video game play in home | Behavioural | Intervention |
Primary outcome
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).
9 secondary outcomes
Change in Disruptive Behavior Disorder Rating Scale (DBDRS) - Oppositional/Defiant Factor Score from baseline to 3 Months
Time frame: Baseline, 3 months
Change in Affective Reactivity Index - Parent (ARI-P) from baseline to 3 Months
Time frame: Baseline, 3 months
Change in Parent Stress Index - Short Form (PSI-SF) from baseline to 3 Months
Time frame: Baseline, 3 months
Clinical Global Impression - Improvement, Irritability/Anger (CGI-I Irritability/Anger)
Time frame: 3 months
Clinical Global Impression - Improvement, Aggression (CGI-I Aggression)
Time frame: 3 months
Clinical Global Impression - Improvement, Oppositional/Defiant Behavior (CGI-I Oppositional/Defiant Behavior)
Time frame: 3 months
Clinical Global Impression - Improvement, Disruptive Behavior (CGI-I Disruptive Behavior)
Time frame: 3 months
Change in Parent Confidence and Resources from baseline to 3 Months
Time frame: Baseline, 3 months
Change in NIH-Emotion Toolbox from baseline to 3 Months
Time frame: Baseline, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mightier video games in people with Emotional Dysregulation, run by Neuromotion Labs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral healthcare utilization cost (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025; AzTrials last refreshed its copy on 30 Oct 2026.