Mightier Video Games for Emotional Dysregulation

Overseen By Jason Kahn, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Neuromotion Labs

Disqualifiers: Low IQ, Limited verbal capacity, Recent medication change, Suicidal ideation, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a video game platform called Mightier, designed to help children manage their emotions better. It targets children aged 8 to 12 with conditions like ADHD or autism who have recently used behavioral health services. Participants will either use Mightier at home for six months or continue their usual treatment. The trial aims to determine if Mightier can reduce emotional issues and stress in children and their parents while integrating digital mental health support into traditional care systems. Families with internet access and a computer or tablet at home may be a good fit for this trial. As an unphased trial, it offers families the chance to explore innovative digital tools for emotional support in children.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have changed your medication or dosage in the past month or plan to change it in the next month.

What prior data suggests that the Mightier video games are safe for children?

Research has shown that video games like Mightier, which use biofeedback, can help children improve emotional management. Studies have found that 75% of families using Mightier report improvements in their child's emotional control. As a commercial product, Mightier is generally well-received. No major reports of negative effects have emerged from children using the game, suggesting that Mightier is likely a safe method for children to learn emotional management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mightier video games for emotional dysregulation because they offer a unique, interactive approach that differs from traditional therapies like medication and cognitive-behavioral therapy. Unlike standard treatments, which often involve direct interventions or talk therapy, Mightier games use biofeedback through gameplay to help users manage their emotions in real-time. This method not only engages users in a fun and accessible way but also empowers them to develop self-regulation skills through repeated practice in a non-clinical setting. This innovative approach holds promise for making emotional regulation more engaging and effective, especially for younger individuals who might find traditional therapies challenging to engage with.

What evidence suggests that Mightier video games are effective for emotional dysregulation?

Research has shown that Mightier video games can help children who struggle with emotional regulation. In this trial, some participants will use Mightier video games, which studies have found can lead to fewer emotional outbursts and improved emotional control. Approximately 87% of families observed improvements in their child's emotional management within 90 days of using the platform. The games employ biofeedback, a method that helps children understand and manage their emotions by displaying their body's reactions. Overall, these findings suggest that Mightier can be a valuable tool for children who have difficulty managing their emotions. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My insurance is through Magellan Healthcare or I have Massachusetts insurance with online benefits access.

Access to a computer or tablet in the home

You need to have WiFi at your home to connect to the Mightier tablet.

Exclusion Criteria

I have significant difficulty speaking.

Active suicidal ideation

Evidence of psychosis, mania, alcohol use disorder, substance use disorder, or PTSD by MINI-Kid

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Treatment

Participating children are randomized into Mightier or treatment as usual control groups for 6 months

6 months

Follow-up

Behavioral healthcare utilization will be observed for 12 months to assess long-term outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Mightier video games

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Six months of ad lib Mightier play in home

Group II: Treatment as usual Active Control 1 Intervention

Who Is Running the Clinical Trial?

Neuromotion Labs

Lead Sponsor

Trials

7

Recruited

3,600+

Magellan Healthcare

Collaborator

Trials

1

Recruited

200+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study of 101 youths with ADHD, emotional dysregulation was frequently observed in those with Internet Gaming Disorder (IGD), highlighting a significant link between gaming addiction and emotional challenges.

Treatment for IGD showed substantial efficacy, with symptoms of disruptive mood dysregulation decreasing by up to 84.4% over four weeks when ADHD symptoms were managed, suggesting that addressing ADHD can improve outcomes for those with IGD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Efficacy of Internet Gaming Disorder With Attention Deficit Hyperactivity Disorder and Emotional Dysregulaton. Chang, CH., Chang, YC., Cheng, H., et al.[2021]

Applied games, including serious games and gamification, can enhance mental health internet interventions by reaching more users, increasing engagement, and utilizing various therapeutic mechanisms.

There is promising evidence supporting the effectiveness of serious games for depression, but more independent trials and comparisons with traditional interventions are needed to fully understand their impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious Games and Gamification for Mental Health: Current Status and Promising Directions. Fleming, TM., Bavin, L., Stasiak, K., et al.[2022]

The video game MindLight, designed with evidence-based therapeutic techniques, has shown significant improvements in anxiety symptoms in children, with effects lasting up to 6 months after intervention, based on results from two randomized controlled trials.

Changes in specific in-game behaviors that reflect therapeutic techniques were found to predict reductions in anxiety symptoms three months after the children stopped playing, suggesting that engagement with these techniques is crucial for the game's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-Game Play Behaviours during an Applied Video Game for Anxiety Prevention Predict Successful Intervention Outcomes. Wols, A., Lichtwarck-Aschoff, A., Schoneveld, EA., et al.[2023]

An active biofeedback video game integrated into cognitive behavioral therapy has been developed to help children improve their emotional regulation skills by requiring them to manage emotions while completing a challenging task.

Early studies indicate that this approach is more effective than traditional treatments in enhancing emotional control, and it has inspired the creation of emotionally aware toys for younger children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"RAGE-Control": A Game to Build Emotional Strength. Kahn, J., Ducharme, P., Rotenberg, A., et al.[2015]

Video game-based assessment tools have been found effective in distinguishing between children with ADHD and those without, as well as identifying different ADHD subtypes, based on a review of 22 studies.

Video game-based therapeutic interventions are generally well accepted and effective in improving cognitive functions and reducing ADHD symptoms, with gamification and cognitive training being key mechanisms of their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video games for the assessment and treatment of attention-deficit/hyperactivity disorder: a systematic review. Peñuelas-Calvo, I., Jiang-Lin, LK., Girela-Serrano, B., et al.[2022]

Therapeutic video games like Treasure Hunt, Camp Cope-A-Lot, and SPARX have been developed to support the treatment of various mental health issues in children and adolescents, including anxiety and depression.

Despite the potential benefits of these games, the development of therapeutic video games is slow due to high costs and rigorous evaluation requirements, although they are expected to play a significant role in future psychotherapy practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New Developments in Video Games for Psychotherapy]. Brezinka, V.[2016]

RAGE Control is a computer-based intervention designed to help children improve emotional control by combining relaxation techniques with executive function tasks, like quick reaction games.

The program is based on Cognitive Behavioral Therapy principles and is currently used in clinical settings, suggesting its potential effectiveness in reducing reliance on psychotropic medications for emotional regulation in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RAGE Control: Regulate and Gain Emotional Control. Kahn, J., Ducharme, P., Travers, B., et al.[2009]

The FDA has approved EndeavorRx, a game-based digital therapeutic device, as the first of its kind for treating ADHD in children aged 8-12, specifically targeting inattentive or combined-type ADHD.

EndeavorRx has been shown to improve attention in pediatric patients, as measured by computer-based testing, indicating its potential efficacy as a non-pharmacological treatment option alongside traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital health interventions (DHI) for the treatment of attention deficit hyperactivity disorder (ADHD) in children - a comparative review of literature among various treatment and DHI. Pandian, GSB., Jain, A., Raza, Q., et al.[2021]

A systematic review of 49 studies involving 32 digital games shows that video game interventions can effectively support mental health treatment for young people aged 12-29, particularly for mild to moderate mental health conditions.

Stakeholder involvement in the development and evaluation of these games was high, indicating a collaborative approach, but the review noted a lack of attention to potential harms associated with these digital interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gaming My Way to Recovery: A Systematic Scoping Review of Digital Game Interventions for Young People's Mental Health Treatment and Promotion. Ferrari, M., Sabetti, J., McIlwaine, SV., et al.[2022]

In a randomized controlled trial with 72 children aged 7-12, the biofeedback-based video game Mightier significantly improved adaptive emotion regulation and reduced emotional dysregulation and behavioral issues after 6 weeks of use in a community setting.

Caregivers of children who played Mightier reported lower levels of parenting-related stress, suggesting that such interventions can benefit not only the children but also their families, especially in communities with limited access to traditional mental health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback-Based Videogames: Fostering Emotion Regulation at a Diverse Community Summer Camp. Mannweiler, M., Schuermann, H., Peechatka, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8960945/

A descriptive study assessing parent perspectives This study is a retrospective data analysis-based evaluation of a commercially available e-mental health program that includes biofeedback video games.

2. mightier.com mightier.com/science/

Science & Research Mightier is clinically validated, with research showing it reduces outbursts and strengthens emotional control. 87% of families see improvements in 90 days. It ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05080647

Examining the Impacts of Parent Mightier Play Mightier is a mobile app-based biofeedback video game platform that facilitates emotion regulation skill-building among children ages 6-14. The technology ...

4. mightier.com mightier.com/wp-content/uploads/2022/08/Mightier-proof-of-concept.pdf

A “Proof of Concept” Randomized Controlled Trial of a ... Emotional dysregulation, defined as a limited ability to initiate and regulate one's emotional reaction and response in a manner consistent with ...

5. withpower.com withpower.com/trial/phase-2-2021-bdf6b

Mightier Video Games for Emotional Dysregulation What data supports the effectiveness of the Mightier video games treatment for emotional dysregulation? Research shows that biofeedback-based video games ...

6. mightier.com mightier.com/

Mightier: Home Mightier helps kids control emotions, build confidence, and improve mental health while supporting the whole family.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04732806

Study Details | NCT04732806 | A Mightier Healthcare System created Mightier, an app-based heart rate biofeedback videogame platform designed to teach and facilitate practice of emotional regulation skills. The ...