An interventional study of Mightier online gameplay in Emotional Regulation, sponsored by Neuromotion Labs. Completed at 1 site in United States. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-09.
Sponsored by Neuromotion Labs · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 197 studies in Emotional Regulation with a site in United States — 60 open to participants now, 76 under way, none of them phase 3. Emotional Regulation · United States.
Among the 197 studies in Emotional Regulation with a site in United States, this one is the 134th largest by enrollment of the 184 interventional ones that give a count, is one of 16 that started in 2021, is one of 175 with no phase, and was the 79th registered.
547 studies on the registry are indexed under Emotional Regulation; 190 are open to participants now.
Browse Emotional Regulation studies →60 of the 197 studies in Emotional Regulation with a site in United States are open now. Recruiting first, the newest first:
State University of New York - Upstate Medical University · Sites in United States
Ages 12–29
University of Florida · Sites in United States
Ages 18–24 · Healthy volunteers
University of Florida · Sites in United States
Ages 18–22 · Healthy volunteers
Massachusetts General Hospital · Sites in United States
Ages 22–65
Sam Houston State University · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 136 Emotional Regulation studies recruiting now, 36 (26%) set no upper age limit and 96 (71%) stop at 75 or younger; 47 take children under 18; 66 take healthy volunteers.
This study: 6 Years to 12 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
197 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 5 · Phase 4 1
First in 1988; this study’s year is marked. 16 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 41 is below the median of 80 across 500 interventional studies indexed under Emotional Regulation.
Median enrollment 74 across the 184 interventional studies, 56 across the 13 observational. Of the 112 that completed or were terminated, 18 (16%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 197 have an industry lead sponsor. The 10 most frequent:
Neuromotion Labs is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Neuromotion Labs has 5 studies filed under Emotional Regulation — fewer than ten, so there is no comparison to draw.
28 of the studies in Emotional Regulation with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05414708Walter Reed National Military Medical CenterArt Therapy and Emotional Well Being in Military Populations With Posttraumatic Stress Symptoms | 2026-12 |
| NCT06019377Portland State UniversityIntervention to Enhance Coping and Help-seeking Among Youth in Foster Care | 2026-12-31 |
| NCT06755827Texas Tech UniversityPilot Testing a Novel Approach to Pediatric Obesity Treatment | 2026-12-31 |
| NCT05651295Matthew Southward, PhDA Precision Medicine Approach to Target Engagement for Emotion Regulation | 2026-12-31 |
| NCT05781100California Polytechnic State University-San Luis ObispoInvestigating Baby Behavior and Family Technology Use Study | 2027-01-01 |
Add all 28 to your calendar (.ics) → With an account.
Among the 197 studies in Emotional Regulation with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A randomized controlled trial comparing a group in which only child participants play Mightier video games for 8 weeks (Child Play group) to a group in which child and parent participants play Mightier video games for 8 weeks (Child and Parent Play group).
Mightier is a mobile app-based biofeedback video game platform that facilitates emotion regulation skill-building among children ages 6-14. The technology behind Mightier's mobile app has been validated in two independent sham-controlled randomized controlled trials, where the investigators have seen decreases in clinical symptoms of aggression and disruptive behaviors, as well as lowered family stress without adverse events.
The study utilizes a parallel randomized controlled design comparing groups of participant families whose children play Mightier video games without parent play to groups of participant families in which both children and parents play Mightier video games. Self-report measures will be completed by participant children and parents.
The study consists of three primary phases: Pre-Study, Active Engagement, and Follow-Up. During the Pre-Study Phase, participants will undergo pre-screening and screening to evaluate interest and eligibility for the study, and participants who consent to participate in the study will complete baseline measures and be randomized into treatment groups. Mightier games will be shipped to participants during or shortly after their Pre-Study call. Participants will be instructed to begin Mightier gameplay as soon as Mightier games arrive at their homes, which will begin the Active Engagement Phase of the study.
During the 8-week Active Engagement Phase, participants will be encouraged to play Mightier games in a way that corresponds to their study condition, and they will be offered engagement support in the form of brief weekly check-ins.
After completion of the Active phase, participants will have a brief Follow-up phase, consisting of one video call during which child and parent participants will complete self-report follow-up measures.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
8 weeks of use ad-libitum. Parents will be encouraged to have their children play Mightier games at least 3 times a week (totalling 45 minutes or more play each week) for the 8-week duration. Parents in the Child Play condition will be advised specifically to not play Mightier for the 8-week duration of the study.
Behavioral: Mightier online gameplay
8 weeks of use ad-libitum. Parents will be encouraged to have their children play Mightier games at least 3 times a week (totalling 45 minutes or more of play each week) for the 8-week duration. Additionally, parents in the Child and Parent Play condition will be encouraged to play Mightier games at least once a week (totalling 15 minutes or more of play each week) for the 8-week duration.
Behavioral: Mightier online gameplay
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, dedicated Mightier tablet unless the family prefers to use their own device) and the Mightier App. Children wear a "Mighty Band" heart rate monitor on their arm while they play any one of 26+ games. As their heart rate rises the games become more difficult. For example, during a cooking game, smoke may appear on the screen and obscure the player's view. Children can either opt into an explicit cool down activity (deep breathing, progressive muscle relaxation, crossing the midline, or visualization) or cool down on their own. By simply playing Mightier, children are motivated to practice calming strategies in moments of challenge.
Also known as: Mightier
Change in child behavior and emotion problems measured on BFS at Week 8
Behavior and Feelings Survey (BFS): The BFS (Weisz et al., 2014) is a 12-item scale measuring child behavior and emotion problems. The child's parent is prompted to read the survey questions to the child and to note the child's responses. The researcher will screen share the BFS form and record child responses in the form. Children will complete the BSF at baseline and Week 8. Items are rated on a scale from 0 (not a problem) to 4 (a very big problem). Three scale scores can be derived: Internalizing Problems (sum of items 1-6), Externalizing Problems (sum of items 7-12), and Total Problems (sum of items 1-12).
Time frame: Baseline and Week 8
Change in child irritability from baseline measured on ARI-P at Week 8
Affective Reactivity Index-Parent Report (ARI-P): 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 (Stringaris et al., 2012). The individual items are scored 0,1, 2, and only the first six items are summed to form the total score, with a minimum score of 0 and a maximum score of 18, and higher scores indicating greater severity of irritability symptoms. The seventh item is an impairment item and it is analysed separately, with a minimum score of 0 and a maximum score of 3, and higher scores indicating greater irritability symptom severity. Parent participants will complete the ARI-P at baseline and Week 8.
Time frame: Baseline and Week 8
Parent perception of change in child emotion regulation from baseline measured on GIS at Week 8
Global Improvement Scale (GIS): The GIS is a parent self-report question that asks parents if they have noticed any overall improvements in their child's emotion regulation, with response options ranging from (1) very much improved to (7) very much worse. Minimum score = 1, Maximum score = 7, with higher numbers indicating less improvement, or worsening. The GIS has not been scientifically validated. Parent participants will complete the GIS at Week 8.
Time frame: Baseline and Week 8
Change in parent emotion regulation from baseline measured on DERS-18 at Week 8
Difficulties in Emotion Regulation Scale, 18-question short form (DERS-18): The DERS-18 (Victor \& Klonsky, 2016) is an 18-question measure of the respondent's emotion regulation experiences. For scoring, three responses are reverse-coded then all responses are summed, resulting in an overall score and scores on 6 subscales: Awareness, Clarity, Goals, Impulse, Nonacceptance, and Strategies. Higher scores indicate greater emotion regulation difficulties. Parent participants will complete the DERS-18 at baseline and Week 8.
Time frame: Baseline and Week 8
Change in parent beliefs about intervention credibility and effectiveness from baseline, measured on the CEQ-P at Week 4 and Week 8
Credibility and Expectancies Questionnaire - Parent Version (CEQ-P): Parent participants will respond to the CEQ-P (Nock et al., 2007), a 6-question assessment of their beliefs about credibility and effectiveness of the intervention, at baseline, Week 4, and Week 8. Items 1, 2, 3, and 5 are scored on a nine-point scale (1 = not a lot / not much; 9 = a lot / very much). Items 4 and 6 are scored on an 11-point scale (e.g., 0-100%), then recoded for scoring to correspond to the 1-9 point scale used for items 1-3 and 5, collapsing the values from 40-60% into one value, 5.
Time frame: Baseline, Week 4, and Week 8
Change in child-parent relationship from baseline, measured on the CPRS-SF at Week 8
Child-Parent Relationship Scale (CPRS-SF): The CPRS-SF (Pianta, 1992) is a 15-item self-report instrument completed by parents that assesses their perceptions of their relationship with their child. The 15 items are rated on 5-point Likert scales. It is applicable to children ages 3-12. The CPRS-SF is scored in two subscales: an 8-item Conflict subscale (minimum score = 8, maximum score = 40, higher score indicates greater conflict), and a 7-item Closeness subscale (minimum score = 7, maximum score = 35, with greater score indicating greater closeness). Parent participants will complete the CPRS-SF at baseline and Week 8.
Time frame: Baseline and Week 8
Plan to share: No — Only Mightier research staff will have access to individual participant data, including family demographics data and data from child and parent self-report measures.
Ran from Oct 2021 to primary completion in Mar 2022, 4 months.
Of 397 interventional studies with no phase under Emotional Regulation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Neuromotion Labs