Emotional RegulationNCT05652114
Open Label Mightier Play in the Home
A study testing Mightier in people with Emotional Regulation, run by Neuromotion Labs at 1 site in United States.
Trial summary
Mightier is a digital mental health tool that uses video game-based heart rate biofeedback to teach emotion regulation. The primary goal of this study is to replicate results from original clinical trials, demonstrating that playing Mightier at home improves common symptoms associated with emotional dysregulation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Emotional Regulation
- What is being tested?
- Mightier
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,732 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2020to 17 Nov 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent or caregivers have a child engaging with the heart rate biofeedback intervention Mightier
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Impact of Mightier Play on Common Pediatric Symptoms in an Uncontrolled Environment
Mightier is a digital mental health tool that uses video game-based heart rate biofeedback to teach emotion regulation. The primary goal of this study is to replicate results from original clinical trials, demonstrating that playing Mightier at home improves common symptoms associated with emotional dysregulation.
Participants will be caregivers of children who are using Mightier, a video-game based heart rate biofeedback intervention. Caregivers will be asked to complete a short survey about their child's emotions and behaviors prior to their child's first play and then complete that survey two more times, at 8 weeks and 12 weeks post baseline.
The pre-post self report design will allow us to observe changes during Mightier use and relate those changes to overall engagement with the intervention
Read the detailed description
Mightier is a video-game-based biofeedback intervention that capitalizes on children's love of video games to increase emotional awareness and facilitate emotion regulation practice through heart rate (HR) control. Each family receives a Mightier Kit (Mighty Band heart rate monitor and dedicated tablet), the Mightier App, online caregiver resources, and dedicated 1-on-1 support from a licensed clinician. The effectiveness of Mightier has been supported through several studies in children ages 8-18, specifically reducing symptoms of aggression, oppositional behavior, and parental stress. The core hypothesis underlying Mightier is that learning to regulate autonomic arousal via HR regulation during gameplay will lead to greater emotional regulation capacity. This hypothesis has considerable support, as greater dynamic HR control is associated with greater emotional clarity, emotion regulation, and impulse control in both adults and children.
Although originally created and studied in an academic medical center, it is not well understood how these learnings translate to change in a more diverse population in a less well-controlled environment (i.e. the home) with varying engagement with the intervention. Increased understanding of the Mightier population's behavioral and symptom characteristics, and the interplay between individual characteristics, engagement, HR, and symptom change is imperative to improving the intervention.
For this proposed study, we hypothesize the following:
- Participants will report reduction in symptoms after 12 weeks of Mightier
- Participants will show reduction in median HR during gameplay after 12 weeks of Mightier
- The magnitude of this change will be greater in externalizing symptoms
- Change in symptoms will be inversely associated with total playtime such that children who play Mightier more will see the largest change (i.e. reduction) in symptoms
- Changes in symptoms will be associated with change in median HR during gameplay, such that larger reductions in symptoms will be associated with larger reductions in HR during gameplay
After consent is obtained, caregivers will begin the survey. They will first be asked to identify whether symptoms associated with Anxiety, Attention Deficit Hyperactivity Disorder (ADHD), irritability, or aggression best describe their child. Based on these responses, caregivers will be asked to complete one of four validated symptom questionnaires. Those who indicated symptoms of anxiety best describe their child will complete the SCARED, a 41 item measure of symptoms of Anxiety related disorders. Those who indicated symptoms of ADHD best describe their child will complete the NICHQ Vanderbilt Assessment Scale, a 55 item measure of symptoms and ratings of functional performance associated with ADHD and Oppositional Defiant Disorder. Those who indicated aggression and aggressive behaviors best describe their child will complete the MOAS, a 4 item measure of verbal aggression, physical aggression, aggression against property, and autoaggression. Finally, those who indicated that symptoms of irritability best describe their child will complete the ARI a 7 item measure of irritability. Upon completion of the respective scale, caretakers will be thanked and informed that they will be contacted in approximately 8-12 weeks.
For the duration of the 8-12 week intervention period, participants will play Mightier ad libitum.
- Conditions
- Emotional Regulation
- Being tested
- Mightier
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MightierBehavioural
Mightier is an app-based biofeedback video game that utilizes heart rate (HR) monitoring during game play to teach and facilitate practice of emotional regulation skills in children.
| Study group | Role | What they receive |
|---|---|---|
| Child play of Mightier | Experimental | Ad lib child biofeedback video game play in home Receives: Behavioral: Mightier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Affective Reactivity Index - Parent
The Affective Reactivity Index is a 7 item parent reported measure of irritability. Scores range from 0-12, with higher scores representing greater irritability.
Measured: 12 weeks
Modified Overt Aggression Scale
The Modified Overt Aggression Scale is a 4 item, caregiver report measure of verbal aggression, physical aggression, aggression against property, and autoaggression. Scores range from 0 to 40, with higher scores indicating more aggression.
Measured: 12 weeks
Secondary outcomes (2)
Screen for Anxiety Related Emotional Disorders
The Screen for Anxiety Related Emotional Disorders is a 41 item measure of symptoms of anxiety related disorders. Scores range from 0-82, with higher scores representing more severe anxiety. Scores >25 indicating high likelihood of an anxiety disorder.
Measured: 12 weeks
National Institute for Children's Health Quality Vanderbilt Assessment Scale
NIHQ Vanderbilt Assessment Scale is a 55 item measure of symptoms and ratings of functional performance associated with ADHD and Oppositional Defiant Disorder. Scores are broken into 5 subscales with a set of performance questions. Higher scores on all scales represent more severe symptoms and/or impairment. To meet criteria across all 5 domains, parents must endorse a score of 2 or 3 on a specified number of symptoms and a 4 or 5 on at least one performance question.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start10 Apr 2020
- Primary completion17 Nov 2022
- Study completion17 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional RegulationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- As a single arm study all participants' children will receive a game-based biofeedback intervention. They are encouraged to engage with the intervention in an entirely self-directed manner.
- Masking
- None (open label)
- Enrolment
- 2,732 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuromotion Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Alyssa Peechatka, Neuromotion Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652114
- Sponsor's protocol ID
- NML
- Status last verified
- Jan 2023
- First submitted
- 7 Dec 2022
- Last updated
- 4 Jan 2023
- 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 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Mightier Play on Common Pediatric Symptoms in an Uncontrolled Environment
- ClinicalTrials.gov ID
- NCT05652114
- Acronym / sponsor ID
- NML
- Conditions
- Emotional Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,732 participants (actual)
- Lead sponsor
- Neuromotion LabsIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 15 Dec 2022 (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.
Mightier is a digital mental health tool that uses video game-based heart rate biofeedback to teach emotion regulation. The primary goal of this study is to replicate results from original clinical trials, demonstrating that playing Mightier at home improves common symptoms associated with emotional dysregulation.
Participants will be caregivers of children who are using Mightier, a video-game based heart rate biofeedback intervention. Caregivers will be asked to complete a short survey about their child's emotions and behaviors prior to their child's first play and then complete that survey two more times, at 8 weeks and 12 weeks post baseline.
The pre-post self report design will allow us to observe changes during Mightier use and relate those changes to overall engagement with the intervention
Detailed description
Mightier is a video-game-based biofeedback intervention that capitalizes on children's love of video games to increase emotional awareness and facilitate emotion regulation practice through heart rate (HR) control. Each family receives a Mightier Kit (Mighty Band heart rate monitor and dedicated tablet), the Mightier App, online caregiver resources, and dedicated 1-on-1 support from a licensed clinician. The effectiveness of Mightier has been supported through several studies in children ages 8-18, specifically reducing symptoms of aggression, oppositional behavior, and parental stress. The core hypothesis underlying Mightier is that learning to regulate autonomic arousal via HR regulation during gameplay will lead to greater emotional regulation capacity. This hypothesis has considerable support, as greater dynamic HR control is associated with greater emotional clarity, emotion regulation, and impulse control in both adults and children.
Although originally created and studied in an academic medical center, it is not well understood how these learnings translate to change in a more diverse population in a less well-controlled environment (i.e. the home) with varying engagement with the intervention. Increased understanding of the Mightier population's behavioral and symptom characteristics, and the interplay between individual characteristics, engagement, HR, and symptom change is imperative to improving the intervention.
For this proposed study, we hypothesize the following:
- Participants will report reduction in symptoms after 12 weeks of Mightier
- Participants will show reduction in median HR during gameplay after 12 weeks of Mightier
- The magnitude of this change will be greater in externalizing symptoms
- Change in symptoms will be inversely associated with total playtime such that children who play Mightier more will see the largest change (i.e. reduction) in symptoms
- Changes in symptoms will be associated with change in median HR during gameplay, such that larger reductions in symptoms will be associated with larger reductions in HR during gameplay
After consent is obtained, caregivers will begin the survey. They will first be asked to identify whether symptoms associated with Anxiety, Attention Deficit Hyperactivity Disorder (ADHD), irritability, or aggression best describe their child. Based on these responses, caregivers will be asked to complete one of four validated symptom questionnaires. Those who indicated symptoms of anxiety best describe their child will complete the SCARED, a 41 item measure of symptoms of Anxiety related disorders. Those who indicated symptoms of ADHD best describe their child will complete the NICHQ Vanderbilt Assessment Scale, a 55 item measure of symptoms and ratings of functional performance associated with ADHD and Oppositional Defiant Disorder. Those who indicated aggression and aggressive behaviors best describe their child will complete the MOAS, a 4 item measure of verbal aggression, physical aggression, aggression against property, and autoaggression. Finally, those who indicated that symptoms of irritability best describe their child will complete the ARI a 7 item measure of irritability. Upon completion of the respective scale, caretakers will be thanked and informed that they will be contacted in approximately 8-12 weeks.
For the duration of the 8-12 week intervention period, participants will play Mightier ad libitum.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- As a single arm study all participants' children will receive a game-based biofeedback intervention. They are encouraged to engage with the intervention in an entirely self-directed manner.
| Arm | Type | Receives |
|---|---|---|
| Child play of Mightier | Experimental | Behavioral: MightierAd lib child biofeedback video game play in home |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parent or caregivers have a child engaging with the heart rate biofeedback intervention Mightier
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| MightierMightier is an app-based biofeedback video game that utilizes heart rate (HR) monitoring during game play to teach and facilitate practice of emotional regulation skills in children. | Behavioural | Child play of Mightier |
Primary outcome
Affective Reactivity Index - Parent
Time frame: 12 weeks
The Affective Reactivity Index is a 7 item parent reported measure of irritability. Scores range from 0-12, with higher scores representing greater irritability.
Modified Overt Aggression Scale
Time frame: 12 weeks
The Modified Overt Aggression Scale is a 4 item, caregiver report measure of verbal aggression, physical aggression, aggression against property, and autoaggression. Scores range from 0 to 40, with higher scores indicating more aggression.
2 secondary outcomes
Screen for Anxiety Related Emotional Disorders
Time frame: 12 weeks
National Institute for Children's Health Quality Vanderbilt Assessment Scale
Time frame: 12 weeks
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 4 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Emotional Regulation
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Not yet recruiting
Interpersonal Relational Role Analysis Group Therapy for Nursing Students at Risk of Internet Addiction
Internet Addiction
Active, not recruiting
Improving Emotional Wellbeing of University Students: Emotion Regulation
Emotion Regulation
Not yet recruiting
Evaluation of a Novel Quantum-Inspired Intervention (QII) for Children With Autism Spectrum Disorder: A Global Confirmatory Study
Autism Spectrum Disorder, Autism Spectrum Disorder (ASD
Recruiting
Combining Transcranial Magnetic Stimulation With Emotion Regulation Skills Training in Borderline Personality Disorder
Borderline Personality Disorder (BPD)
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 in people with Emotional Regulation, 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 1 inclusion and 1 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 4 Jan 2023. 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?
Affective Reactivity Index - Parent (time frame: 12 weeks). 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 4 Jan 2023; AzTrials last refreshed its copy on 2 Nov 2026.