Emotional RegulationNCT05080647
Examining the Impacts of Parent Mightier Play
A study testing Mightier online gameplay in people with Emotional Regulation, run by Neuromotion Labs at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Regulation
- What is being tested?
- Mightier online gameplay
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2021to 7 Jun 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 6-12 at the time of screening
- Regular access to WiFi (for Mightier gameplay device connection)
Who cannot join
- Prior Mightier use
- Diagnosed Intellectual Disability (by history)
- Planned medication changes during the 8-week study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Impacts of Parent Mightier Play as a Supplement to Child Mightier Play
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).
Read the detailed description
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.
- Conditions
- Emotional Regulation
- Being tested
- Mightier online gameplay
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mightier online gameplayBehavioural
Also called Mightier
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.
| Study group | Role | What they receive |
|---|---|---|
| Mightier Child Play | Active comparator | 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. Receives: Behavioral: Mightier online gameplay |
| Mightier Child and Parent Play | Experimental | 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. Receives: Behavioral: Mightier online gameplay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Baseline and Week 8
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start20 Oct 2021
- Primary completion19 Mar 2022
- Study completion7 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuromotion Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080647
- Sponsor's protocol ID
- 995MIGH21
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2021
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
RC Pianta - Unpublished measure, University of Virginia, 1992
Stringaris A, Goodman R, Ferdinando S, Razdan V, Muhrer E, Leibenluft E, Brotman MA. The Affective Reactivity Index: a concise irritability scale for clinical and research settings. J Child Psychol Psychiatry. 2012 Nov;53(11):1109-17. doi: 10.1111/j.1469-7610.2012.02561.x. Epub 2012 May 10.
PubMed 22574736Weisz JR, Vaughn-Coaxum RA, Evans SC, Thomassin K, Hersh J, Ng MY, Lau N, Lee EH, Raftery-Helmer JN, Mair P. Efficient Monitoring of Treatment Response during Youth Psychotherapy: The Behavior and Feelings Survey. J Clin Child Adolesc Psychol. 2020 Nov-Dec;49(6):737-751. doi: 10.1080/15374416.2018.1547973. Epub 2019 Jan 18.
PubMed 30657721Nock, M.K., Ferriter, C. & Holmberg, E. Parent Beliefs about Treatment Credibility and Effectiveness: Assessment and Relation to Subsequent Treatment Participation. J Child Fam Stud 16, 27-38 (2007). https://doi.org/10.1007/s10826-006-9064-7
Victor, S.E., Klonsky, E.D. Validation of a Brief Version of the Difficulties in Emotion Regulation Scale (DERS-18) in Five Samples. J Psychopathol Behav Assess 38, 582-589 (2016). https://doi.org/10.1007/s10862-016-9547-9
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impacts of Parent Mightier Play as a Supplement to Child Mightier Play
- ClinicalTrials.gov ID
- NCT05080647
- Acronym / sponsor ID
- 995MIGH21
- Conditions
- Emotional Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Neuromotion LabsIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 19 Mar 2022 (actual)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 18 Oct 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.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mightier Child Play | Active comparator | Behavioral: Mightier online gameplay8 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. |
| Mightier Child and Parent Play | Experimental | Behavioral: Mightier online gameplay8 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 6-12 at the time of screening
- Regular access to WiFi (for Mightier gameplay device connection)
Key exclusion criteria (3 listed)
- Prior Mightier use
- Diagnosed Intellectual Disability (by history)
- Planned medication changes during the 8-week study period
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 online gameplayAlso: MightierMightier 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. | Behavioural | Mightier Child Play, Mightier Child and Parent Play |
Primary outcome
Change in child behavior and emotion problems measured on BFS at Week 8
Time frame: Baseline and 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).
Change in child irritability from baseline measured on ARI-P at Week 8
Time frame: Baseline and 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.
Parent perception of change in child emotion regulation from baseline measured on GIS at Week 8
Time frame: Baseline and 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.
3 secondary outcomes
Change in parent emotion regulation from baseline measured on DERS-18 at 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
Time frame: Baseline, Week 4, and Week 8
Change in child-parent relationship from baseline, measured on the CPRS-SF at Week 8
Time frame: Baseline and Week 8
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 9 Jun 2022.
- BackgroundRC Pianta - Unpublished measure, University of Virginia, 1992
- Background: PubMed 22574736Stringaris A, Goodman R, Ferdinando S, Razdan V, Muhrer E, Leibenluft E, Brotman MA. The Affective Reactivity Index: a concise irritability scale for clinical and research settings. J Child Psychol Psychiatry. 2012 Nov;53(11):1109-17. doi: 10.1111/j.1469-7610.2012.02561.x. Epub 2012 May 10.
- Background: PubMed 30657721Weisz JR, Vaughn-Coaxum RA, Evans SC, Thomassin K, Hersh J, Ng MY, Lau N, Lee EH, Raftery-Helmer JN, Mair P. Efficient Monitoring of Treatment Response during Youth Psychotherapy: The Behavior and Feelings Survey. J Clin Child Adolesc Psychol. 2020 Nov-Dec;49(6):737-751. doi: 10.1080/15374416.2018.1547973. Epub 2019 Jan 18.
- BackgroundNock, M.K., Ferriter, C. & Holmberg, E. Parent Beliefs about Treatment Credibility and Effectiveness: Assessment and Relation to Subsequent Treatment Participation. J Child Fam Stud 16, 27-38 (2007). https://doi.org/10.1007/s10826-006-9064-7
- BackgroundVictor, S.E., Klonsky, E.D. Validation of a Brief Version of the Difficulties in Emotion Regulation Scale (DERS-18) in Five Samples. J Psychopathol Behav Assess 38, 582-589 (2016). https://doi.org/10.1007/s10862-016-9547-9
- Individual participant dataSharing planned: 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.
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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 online gameplay 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 2 inclusion and 3 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 9 Jun 2022. 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?
Change in child behavior and emotion problems measured on BFS at Week 8 (time frame: Baseline and Week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05080647, which also lists 5 linked publications.
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 9 Jun 2022.