Emotional RegulationNCT04839861
Examining the Impacts of Parent-Child Interactive Activities
A study testing Mightier Family Games and Mightier online gameplay in people with Emotional Regulation, run by Neuromotion Labs at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the effects of online and offline play of games on the Mightier game platform, in comparison to the effects of Mightier online play alone. 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 Family Games and 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
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2021to 13 Oct 2021
- 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 6-week study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Impacts of Parent-Child Interactive Activities as an Adjunct to Mightier Play
The purpose of this study is to demonstrate the effects of online and offline play of games on the Mightier game platform, in comparison to the effects of Mightier online play alone.
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.
Mightier will soon introduce offline Mightier Family Games to its product line. Mightier Family Games will include offline, interactive components that have not previously been incorporated into Mightier play. Studies have shown that improvements in child behavior and child-parent relationships are among the many benefits of family play.
For the proposed study, families with no prior Mightier exposure will engage in different types of Mightier play for six weeks, to demonstrate the effects of online and offline Mightier play in comparison to the effects of Mightier online play alone. Mightier will recruit families through social media, then Mightier will randomly assign participants to one of two groups: a Mightier online play only group, and a Mightier online and offline play group. The investigators will aim to enroll 20 participants in each group.
- Conditions
- Emotional Regulation
- Being tested
- Mightier Family Games, 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 Family GamesBehavioural
Mightier Family Games includes five offline card games that can be played by two or more people. During card game play, one player wears the Mightier heart rate monitor, and can see a representation of their heart rate on a separate screen within the Mightier app. Each game includes elements that are tied to heart rate.
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.
| Study group | Role | What they receive |
|---|---|---|
| Mightier Online Games | Active comparator | 6 weeks of use ad-libitum. Parents will be encouraged to have their children play Mightier online games at least 3 times a week for the 6 week duration. Receives: Behavioral: Mightier online gameplay |
| Mightier Online Plus Offline Family Games | Experimental | 6 weeks of use ad-libitum. Parents will be encouraged to have their children play Mightier online games at least 3 times a week for the 6 week duration. Parents will be encouraged to play Mightier offline Family Games at least once a week for the 6 week duration. Receives: Behavioral: Mightier Family Games; Behavioral: Mightier online gameplay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child irritability from baseline measured on ARI-P at Week 7
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.
Measured: Baseline and Week 7
Change in child-parent relationship from baseline measured on CPRS-SF at Week 7
Child-Parent Relationship Scale (CPRS-SF): The CPRS-SF is a 15- item The CPRS (Pianta, 1992) is a 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).
Measured: Baseline and Week 7
Parent perception of change in child emotion regulation from baseline measured on GIS at Week 7
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.
Measured: Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start7 May 2021
- Primary completion13 Oct 2021
- Study completion13 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuromotion Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Kahn, PhD, Principal investigator, Neuromotion Labs Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839861
- Sponsor's protocol ID
- 874MIGH21
- Status last verified
- Oct 2021
- First submitted
- 7 Apr 2021
- Last updated
- 20 Oct 2021
- 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 parent self-report measures.
Publications
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 22574736RC Pianta - Unpublished measure, University of Virginia, 1992
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impacts of Parent-Child Interactive Activities as an Adjunct to Mightier Play
- ClinicalTrials.gov ID
- NCT04839861
- Acronym / sponsor ID
- 874MIGH21
- Conditions
- Emotional Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Neuromotion LabsIndustry (pharma, biotech, devices)
- Study start
- 7 May 2021 (actual)
- Primary completion
- 13 Oct 2021 (actual)
- Study completion
- 13 Oct 2021 (actual)
- First posted
- 9 Apr 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.
The purpose of this study is to demonstrate the effects of online and offline play of games on the Mightier game platform, in comparison to the effects of Mightier online play alone.
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.
Mightier will soon introduce offline Mightier Family Games to its product line. Mightier Family Games will include offline, interactive components that have not previously been incorporated into Mightier play. Studies have shown that improvements in child behavior and child-parent relationships are among the many benefits of family play.
For the proposed study, families with no prior Mightier exposure will engage in different types of Mightier play for six weeks, to demonstrate the effects of online and offline Mightier play in comparison to the effects of Mightier online play alone. Mightier will recruit families through social media, then Mightier will randomly assign participants to one of two groups: a Mightier online play only group, and a Mightier online and offline play group. The investigators will aim to enroll 20 participants in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mightier Online Games | Active comparator | Behavioral: Mightier online gameplay6 weeks of use ad-libitum. Parents will be encouraged to have their children play Mightier online games at least 3 times a week for the 6 week duration. |
| Mightier Online Plus Offline Family Games | Experimental | Behavioral: Mightier Family Games, Behavioral: Mightier online gameplay6 weeks of use ad-libitum. Parents will be encouraged to have their children play Mightier online games at least 3 times a week for the 6 week duration. Parents will be encouraged to play Mightier offline Family Games at least once a week for the 6 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 6-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 Family GamesMightier Family Games includes five offline card games that can be played by two or more people. During card game play, one player wears the Mightier heart rate monitor, and can see a representation of their heart rate on a separate screen within the Mightier app. Each game includes elements that are tied to heart rate. | Behavioural | Mightier Online Plus Offline Family Games |
| 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. | Behavioural | Mightier Online Games, Mightier Online Plus Offline Family Games |
Primary outcome
Change in child irritability from baseline measured on ARI-P at Week 7
Time frame: Baseline and Week 7
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.
Change in child-parent relationship from baseline measured on CPRS-SF at Week 7
Time frame: Baseline and Week 7
Child-Parent Relationship Scale (CPRS-SF): The CPRS-SF is a 15- item The CPRS (Pianta, 1992) is a 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 perception of change in child emotion regulation from baseline measured on GIS at Week 7
Time frame: Week 7
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.
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 20 Oct 2021.
- 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.
- BackgroundRC Pianta - Unpublished measure, University of Virginia, 1992
- Individual participant dataSharing planned: No. Only Mightier research staff will have access to individual participant data, including family demographics data and data from 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.
Jason Kahn, PhD principal investigator
Neuromotion Labs Inc
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 Family Games and 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 20 Oct 2021. 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 irritability from baseline measured on ARI-P at Week 7 (time frame: Baseline and Week 7). 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 NCT04839861, which also lists 2 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 20 Oct 2021.