← Back to Search

Behavioral Intervention

Mightier Video Games for Emotional Dysregulation

N/A
Recruiting
Research Sponsored by Neuromotion Labs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 8-12
Evidence of ADHD, ODD, CD, DMDD, IED, or ASD by MINI-KID
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1hz intervals when playing game for 6 months
Awards & highlights

Study Summary

This trial will test whether an app-based heart rate biofeedback videogame platform called Mightier can help children with emotional regulation skills, and whether it can be integrated with traditional healthcare.

Who is the study for?
This trial is for children aged 8-12 with emotional dysregulation issues like ADHD or ASD, who have made a behavioral health claim in the past year. They must be fluent in English, have Wi-Fi and a computer or tablet at home. It's not for kids with severe verbal limitations, recent medication changes, psychosis, mania, substance abuse issues, or those highly sensitive to wearing heart rate monitors.Check my eligibility
What is being tested?
The trial tests Mightier video games designed to help kids manage their emotions better by using biofeedback technology. Children will either use Mightier or continue usual treatments for six months while their healthcare usage is tracked over a year to evaluate Mightier's effectiveness and impact on healthcare costs.See study design
What are the potential side effects?
Since this intervention involves video games that teach emotional regulation through biofeedback without any drugs or invasive procedures involved, there are no typical medical side effects; however participants may experience frustration if they find the game challenging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 8 and 12 years old.
Select...
I have been diagnosed with ADHD, ODD, CD, DMDD, IED, or ASD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1hz intervals when playing game for 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1hz intervals when playing game for 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Behavioral healthcare utilization cost
Change in Modified Overt Aggression Scale (MOAS) from baseline to 3 Months
Secondary outcome measures
Change in Affective Reactivity Index - Parent (ARI-P) from baseline to 3 Months
Change in Disruptive Behavior Disorder Rating Scale (DBDRS) - Oppositional/Defiant Factor Score from baseline to 3 Months
Change in NIH-Emotion Toolbox from baseline to 3 Months
+6 more
Other outcome measures
Behavioral healthcare utilization cost -- billed as medical
Change in Disruptive Behavior Disorder Rating Scale (DBDRS) - Total Score
Customer Satisfaction
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Six months of ad lib Mightier play in home
Group II: Treatment as usualActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Magellan HealthcareUNKNOWN
Neuromotion LabsLead Sponsor
5 Previous Clinical Trials
2,958 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,785 Previous Clinical Trials
2,689,556 Total Patients Enrolled

Media Library

Mightier video games (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04732806 — N/A
Emotional Dysregulation Research Study Groups: Treatment as usual, Intervention
Emotional Dysregulation Clinical Trial 2023: Mightier video games Highlights & Side Effects. Trial Name: NCT04732806 — N/A
Mightier video games (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04732806 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accept candidates who are over four decades of age?

"This clinical trial only allows children between 8 and 12 years old to enroll, in line with the inclusion criteria."

Answered by AI

What objectives are researchers hoping to achieve with this investigation?

"This trial's primary outcome, monitored between Baseline and 3 Months, is Behavioral healthcare utilization cost. Additionally, the study will assess Change in Parent Confidence and Resources from baseline to 3 Months (Two 5 item questions), Clinical Global Impression - Improvement Oppositional/Defiant Behavior (CGI-I Oppositional/Defiant Behavior) scale of 1 to 7 rating total improvement due to treatment as well as Change in NIH-Emotion Toolbox from baseline to 3 months which can recognize a full spectrum of emotional experiences with subdomains such as negative affect, psychological wellbeing, stress and self efficacy & social relationships for 8-"

Answered by AI

Is my profile compatible with the requirements for entering this medical experiment?

"To join the clinical trial, patients must exhibit emotional volatility and be of ages 8 to 12. The total enrollment is expected to reach 200 participants."

Answered by AI

In what capacity is the human sample size participating in this medical study?

"Indeed, this clinical trial is still seeking applicants. It was first uploaded on March 10th 2021 and the latest update occurred on January 21st 2022. At present, 200 patients need to be recruited from a single medical site."

Answered by AI

Does this clinical trial currently have open enrollment for volunteers?

"Affirmative. Clinicaltrials.gov indicates the availability of this clinical trial, which was initially posted on March 10th 2021 and has since been revised as recently as January 21st 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Mightier Healthcare System
2021. "A Mightier Healthcare System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04732806.
~10 spots leftby Jun 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top