Emotional RegulationNCT05260398
Examining the Impacts on In-School Behaviors of In-Home Videogame Play
A study testing Mightier Online Gameplay in people with Emotional Regulation and Problem Behavior, run by Neuromotion Labs at 1 site in United States.
Trial summary
The proposed study aims to investigate the effects of children's in-home engagement with a biofeedback video game-based intervention on children's in-school behaviors. For the proposed study, families with no prior Mightier exposure will engage in online gameplay for eight weeks. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Regulation, Problem Behavior, Irritable Mood
- 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
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2022to 31 Dec 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 6-11 at the time of screening
- Attending school outside of the home and not planning to change schools or classrooms during the 8-week study period
Who cannot join
- Prior Mightier use
- Out-of-home School Teacher unable to complete baseline and follow-up questionnaires
- Planned medication changes during the 8-week study period
- Parents encouraged to self-exclude if their children have severe skin sensitivities
- Parents encouraged to self-exclude if their children are pre-readers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Impacts on In-School Behaviors of In-Home Engagement With a Biofeedback-based Videogame Application
The proposed study aims to investigate the effects of children's in-home engagement with a biofeedback video game-based intervention on children's in-school behaviors. For the proposed study, families with no prior Mightier exposure will engage in online gameplay for eight weeks. Mightier will recruit families through social media and clinical settings, then Mightier will randomly assign participants to one of two groups: a group in which the child participant is encouraged to play Mightier games with biofeedback elements 45 or more minutes a week, broken into 3 or more sessions a week soon after baseline data have been collected, and a group in which the child participant receives Mightier and is invited to play Mightier games with biofeedback elements after all study baseline and follow-up data have been collected. The investigators will aim to enroll 20 parent-child dyads in each group.
Specific Aims and Hypotheses:
- Demonstrate that child engagement in Mightier biofeedback video games is correlated to child improvement in school behaviors. The investigators hypothesize that teachers of child participants will report reductions in child school behavior challenges after 8 weeks of child Mightier gameplay.
- Demonstrate that child engagement in Mightier biofeedback video games is correlated to child improvement in at-home behaviors and general improvement in emotion regulation. The investigators hypothesize that parents of child participants will report a reduction in child behavior challenges and improvements in child emotion regulation after 8 weeks of child Mightier gameplay.
Read the detailed description
Study Design:
A randomized controlled trial comparing pre- and post-measures for a group in which child participants play Mightier video games for the active 8-week study period (Mightier Now group) to a group in which child participants wait during the active 8-week study period, then play Mightier after post-measures are collected (Mightier Later group).
Study Sample:
40 parent-child dyads in which the enrolled children are between 6 and 11 years old, have no prior Mightier experience, and attend school outside the home; 40 school teacher informants, who will complete baseline and follow-up measures on behalf of enrolled children.
Study Aims:
Aim 1. Demonstrate that children's in-home Mightier play is associated with reduced in-school emotional and behavioral problems. The investigators hypothesize that teachers will report reductions in child participants' school emotional and behavioral challenges after 8 weeks of child Mightier gameplay at home.
Aim 2. Demonstrate that children's in-home Mightier play is associated with parent-perceived reductions in child emotional and behavioral challenges and overall improvements in child emotion regulation. The investigators hypothesize that parents will report reductions in child participants' emotional and behavioral challenges and improvements in child emotion regulation after 8 weeks of child Mightier gameplay.
Recruitment Participants will be recruited to the study via social media ads, emails to families who have inquired about Mightier research studies, and clinician and educator referrals.
Screening Families who are interested in enrolling in the study will complete screening via an online questionnaire form to screen for inclusion and exclusion criteria.
During study screening, families will be given a link to share with their child's school teacher, along with sample language that families can use to inform the teacher that the family would like to participate in a research study, that the study requires data at baseline and Week 8 from questionnaires completed by a teacher who sees the student regularly.
Teachers who use the link provided by families who are interested in the study will link to a web page providing information about the research study and asking is the teacher is willing and able to complete study measures.
If children meet inclusion/exclusion criteria and teachers are willing and able to complete questionnaires, then parents/guardians and child participants will be invited to schedule a video call to complete study informed consent and assent forms.
Baseline data collection Parents and teachers will complete baseline questionnaires via online form.
Randomization After baseline questionnaires for a child participant are completed by parent and teacher, the child's family will be randomly assigned to the Mightier Now study cohort or the Mightier Later study cohort.
Before enrollment starts, a randomization list 60 subjects long will be created. Participants will be assigned to groups per this list, in the same order in which participants enroll in the study.
Intervention Families in the Mightier Now cohort will receive a Mightier shipment via UPS and will be directed to encourage child participants to play Mightier in their homes on an ad lib basis for eight weeks. Families in the Mightier Later cohort will be advised that their Mightier shipment will arrive after Week 8 questionnaires have been completed by a parent and teacher of the child participant.
Study check-ins Research staff will check in with families at weeks 0, 2, 4, and 6 of the study.
Study check-ins will consist of:
An email from research staff acknowledging child cumulative Mightier play minutes and encouraging ongoing play, Mightier gameplay engagement support, and links for scheduling study phone calls or zoom calls, at the discretion and preference of study participants.
Safety monitoring Participant safety will be assessed at study visits. Adverse events will be monitored and recorded. Concerns about participant safety will be reviewed by a clinician-on-call, a licensed clinical social worker, who will aid with referrals to local authorities as necessary.
Follow-up data collection Parents and teachers will complete follow-up questionnaires via online form as close as possible to 8 weeks after start of play.
Duration of treatment:
8 weeks of use ad-libitum. Parents in the Mightier Now study cohort will be encouraged to have their children play Mightier games at least 3 times a week / at least 45 minutes per week of Mightier play for the 8 week duration.
Parents in the Mightier Later study cohort will be reminded that they are in a "wait list" cohort, and that their Mightier shipment will arrive after parents and teachers complete the baseline and follow-up questionnaires.
- Conditions
- Emotional Regulation, Problem Behavior, Irritable Mood
- Being tested
- Mightier Online Gameplay
- Medical subject headings
- Emotional Regulation, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mightier Online GameplayBehavioural
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 Now | 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. Receives: Behavioral: Mightier Online Gameplay |
| Mightier Later | No intervention | 8 weeks of wait list. Families in the Mightier Later condition will receive their Mightier shipment and will be encouraged to play Mightier after follow-up questionnaires have been completed 8 weeks after parents and teachers complete baseline questionnaires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in in-school problem behaviors from baseline to follow-up
Child Behavior Checklist- Teacher Report Form (CBCL-TRF): The CBCL-TRF (Achenbach \& Rescorla, 2001) assesses child adaptive behaviors and problem behaviors. There are 112 items that assess problem behaviors and 16 items that assess academic performance and adaptive behavior. School teachers of child participants will complete the CBCL-TRF at baseline and Week 8.
Measured: Baseline and Week 8
Change in in-home problem behaviors from baseline to follow-up
Child Behavior Checklist (CBCL/6-18): The CBCL/6-18 (Achenbach \& Rescorla, 2001) assesses child adaptive behaviors and problem behaviors. There are 112 items that assess problem behaviors and 20 items that assess adaptive behavior. Response format for problem behaviors is from 0 ("not true") to 2 ("very true"). Parent participants will complete the CBCL/6-18 at baseline and follow-up.
Measured: Baseline and Week 8
Change in irritable mood from baseline to follow-up
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
Overall emotional regulation improvement as reported by teacher
Clinical Global Impressions Scale Improvement Question (CGI-I): The CGI is a self-report question that asks the respondent if they have noticed any overall improvements in the child's emotion regulation, with response options ranging from (1) very much improved to (7) very much worse. The Teacher CGI-I has not been scientifically validated for use in research studies. Teachers of child participants will complete the CGI-I at follow-up.
Measured: Week 8
Overall emotional regulation improvement as reported by parent
Clinical Global Impressions Scale Improvement Question (CGI-I): The CGI is a self-report question that asks the respondent if they have noticed any overall improvements in the child's emotion regulation, with response options ranging from (1) very much improved to (7) very much worse. The Parent CGI-I has not been scientifically validated for use in research studies. Parents of child participants will complete the CGI-I at follow-up.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start28 Feb 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuromotion Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260398
- Sponsor's protocol ID
- 1076MIGH22
- Status last verified
- Jun 2022
- First submitted
- 7 Feb 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ducharme P, Kahn J, Vaudreuil C, Gusman M, Waber D, Ross A, Rotenberg A, Rober A, Kimball K, Peechatka AL, Gonzalez-Heydrich J. A "Proof of Concept" Randomized Controlled Trial of a Video Game Requiring Emotional Regulation to Augment Anger Control Training. Front Psychiatry. 2021 Sep 1;12:591906. doi: 10.3389/fpsyt.2021.591906. eCollection 2021.
PubMed 34539455Achenbach, T. M., & Rescorla, L. A. (2001). Manual for the ASEBA School-Age Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families.
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 22574736Guy, WBRR (1976). CGI. Clinical global impressions. ECDEU assessment manual for psychopharmacology.
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 on In-School Behaviors of In-Home Engagement With a Biofeedback-based Videogame Application
- ClinicalTrials.gov ID
- NCT05260398
- Acronym / sponsor ID
- 1076MIGH22
- Conditions
- Emotional Regulation, Problem Behavior, Irritable Mood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Neuromotion LabsIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Mar 2022 (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 proposed study aims to investigate the effects of children's in-home engagement with a biofeedback video game-based intervention on children's in-school behaviors. For the proposed study, families with no prior Mightier exposure will engage in online gameplay for eight weeks. Mightier will recruit families through social media and clinical settings, then Mightier will randomly assign participants to one of two groups: a group in which the child participant is encouraged to play Mightier games with biofeedback elements 45 or more minutes a week, broken into 3 or more sessions a week soon after baseline data have been collected, and a group in which the child participant receives Mightier and is invited to play Mightier games with biofeedback elements after all study baseline and follow-up data have been collected. The investigators will aim to enroll 20 parent-child dyads in each group.
Specific Aims and Hypotheses:
- Demonstrate that child engagement in Mightier biofeedback video games is correlated to child improvement in school behaviors. The investigators hypothesize that teachers of child participants will report reductions in child school behavior challenges after 8 weeks of child Mightier gameplay.
- Demonstrate that child engagement in Mightier biofeedback video games is correlated to child improvement in at-home behaviors and general improvement in emotion regulation. The investigators hypothesize that parents of child participants will report a reduction in child behavior challenges and improvements in child emotion regulation after 8 weeks of child Mightier gameplay.
Detailed description
Study Design:
A randomized controlled trial comparing pre- and post-measures for a group in which child participants play Mightier video games for the active 8-week study period (Mightier Now group) to a group in which child participants wait during the active 8-week study period, then play Mightier after post-measures are collected (Mightier Later group).
Study Sample:
40 parent-child dyads in which the enrolled children are between 6 and 11 years old, have no prior Mightier experience, and attend school outside the home; 40 school teacher informants, who will complete baseline and follow-up measures on behalf of enrolled children.
Study Aims:
Aim 1. Demonstrate that children's in-home Mightier play is associated with reduced in-school emotional and behavioral problems. The investigators hypothesize that teachers will report reductions in child participants' school emotional and behavioral challenges after 8 weeks of child Mightier gameplay at home.
Aim 2. Demonstrate that children's in-home Mightier play is associated with parent-perceived reductions in child emotional and behavioral challenges and overall improvements in child emotion regulation. The investigators hypothesize that parents will report reductions in child participants' emotional and behavioral challenges and improvements in child emotion regulation after 8 weeks of child Mightier gameplay.
Recruitment Participants will be recruited to the study via social media ads, emails to families who have inquired about Mightier research studies, and clinician and educator referrals.
Screening Families who are interested in enrolling in the study will complete screening via an online questionnaire form to screen for inclusion and exclusion criteria.
During study screening, families will be given a link to share with their child's school teacher, along with sample language that families can use to inform the teacher that the family would like to participate in a research study, that the study requires data at baseline and Week 8 from questionnaires completed by a teacher who sees the student regularly.
Teachers who use the link provided by families who are interested in the study will link to a web page providing information about the research study and asking is the teacher is willing and able to complete study measures.
If children meet inclusion/exclusion criteria and teachers are willing and able to complete questionnaires, then parents/guardians and child participants will be invited to schedule a video call to complete study informed consent and assent forms.
Baseline data collection Parents and teachers will complete baseline questionnaires via online form.
Randomization After baseline questionnaires for a child participant are completed by parent and teacher, the child's family will be randomly assigned to the Mightier Now study cohort or the Mightier Later study cohort.
Before enrollment starts, a randomization list 60 subjects long will be created. Participants will be assigned to groups per this list, in the same order in which participants enroll in the study.
Intervention Families in the Mightier Now cohort will receive a Mightier shipment via UPS and will be directed to encourage child participants to play Mightier in their homes on an ad lib basis for eight weeks. Families in the Mightier Later cohort will be advised that their Mightier shipment will arrive after Week 8 questionnaires have been completed by a parent and teacher of the child participant.
Study check-ins Research staff will check in with families at weeks 0, 2, 4, and 6 of the study.
Study check-ins will consist of:
An email from research staff acknowledging child cumulative Mightier play minutes and encouraging ongoing play, Mightier gameplay engagement support, and links for scheduling study phone calls or zoom calls, at the discretion and preference of study participants.
Safety monitoring Participant safety will be assessed at study visits. Adverse events will be monitored and recorded. Concerns about participant safety will be reviewed by a clinician-on-call, a licensed clinical social worker, who will aid with referrals to local authorities as necessary.
Follow-up data collection Parents and teachers will complete follow-up questionnaires via online form as close as possible to 8 weeks after start of play.
Duration of treatment:
8 weeks of use ad-libitum. Parents in the Mightier Now study cohort will be encouraged to have their children play Mightier games at least 3 times a week / at least 45 minutes per week of Mightier play for the 8 week duration.
Parents in the Mightier Later study cohort will be reminded that they are in a "wait list" cohort, and that their Mightier shipment will arrive after parents and teachers complete the baseline and follow-up questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mightier Now | 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. |
| Mightier Later | No intervention | –8 weeks of wait list. Families in the Mightier Later condition will receive their Mightier shipment and will be encouraged to play Mightier after follow-up questionnaires have been completed 8 weeks after parents and teachers complete baseline questionnaires. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 6-11 at the time of screening
- Attending school outside of the home and not planning to change schools or classrooms during the 8-week study period
Key exclusion criteria (5 listed)
- Prior Mightier use
- Out-of-home School Teacher unable to complete baseline and follow-up questionnaires
- Planned medication changes during the 8-week study period
- Parents encouraged to self-exclude if their children have severe skin sensitivities
- Parents encouraged to self-exclude if their children are pre-readers
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 GameplayMightier 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 Now |
Primary outcome
Change in in-school problem behaviors from baseline to follow-up
Time frame: Baseline and Week 8
Child Behavior Checklist- Teacher Report Form (CBCL-TRF): The CBCL-TRF (Achenbach \& Rescorla, 2001) assesses child adaptive behaviors and problem behaviors. There are 112 items that assess problem behaviors and 16 items that assess academic performance and adaptive behavior. School teachers of child participants will complete the CBCL-TRF at baseline and Week 8.
Change in in-home problem behaviors from baseline to follow-up
Time frame: Baseline and Week 8
Child Behavior Checklist (CBCL/6-18): The CBCL/6-18 (Achenbach \& Rescorla, 2001) assesses child adaptive behaviors and problem behaviors. There are 112 items that assess problem behaviors and 20 items that assess adaptive behavior. Response format for problem behaviors is from 0 ("not true") to 2 ("very true"). Parent participants will complete the CBCL/6-18 at baseline and follow-up.
Change in irritable mood from baseline to follow-up
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.
Overall emotional regulation improvement as reported by teacher
Time frame: Week 8
Clinical Global Impressions Scale Improvement Question (CGI-I): The CGI is a self-report question that asks the respondent if they have noticed any overall improvements in the child's emotion regulation, with response options ranging from (1) very much improved to (7) very much worse. The Teacher CGI-I has not been scientifically validated for use in research studies. Teachers of child participants will complete the CGI-I at follow-up.
Overall emotional regulation improvement as reported by parent
Time frame: Week 8
Clinical Global Impressions Scale Improvement Question (CGI-I): The CGI is a self-report question that asks the respondent if they have noticed any overall improvements in the child's emotion regulation, with response options ranging from (1) very much improved to (7) very much worse. The Parent CGI-I has not been scientifically validated for use in research studies. Parents of child participants will complete the CGI-I at follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Background: PubMed 34539455Ducharme P, Kahn J, Vaudreuil C, Gusman M, Waber D, Ross A, Rotenberg A, Rober A, Kimball K, Peechatka AL, Gonzalez-Heydrich J. A "Proof of Concept" Randomized Controlled Trial of a Video Game Requiring Emotional Regulation to Augment Anger Control Training. Front Psychiatry. 2021 Sep 1;12:591906. doi: 10.3389/fpsyt.2021.591906. eCollection 2021.
- BackgroundAchenbach, T. M., & Rescorla, L. A. (2001). Manual for the ASEBA School-Age Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families.
- 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.
- BackgroundGuy, WBRR (1976). CGI. Clinical global impressions. ECDEU assessment manual for psychopharmacology.
- Individual participant dataSharing planned: No
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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 and Problem Behavior, 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 5 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: status not confirmed, 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?
Results are not available in the source record.
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 in-school problem behaviors from baseline to follow-up (time frame: Baseline and Week 8). The study lists 5 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 NCT05260398, which also lists 4 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.