Emotional RegulationNCT06580496
Adding Printed CBT Materials to a Pediatric Digital Intervention
A study testing Mightier in people with Emotional Regulation, run by Neuromotion Labs.
Trial summary
The primary goal of this study is to demonstrate that engaging with "offscreen" physical materials that focus on teaching and practicing Cognitive Behavioral Therapy-based skills alongside a digital emotional regulation intervention results in greater symptom improvement in kids than engaging with the digital… Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Emotional Regulation
- What is being tested?
- Mightier
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2024to 15 Feb 2026
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 4-16 years old at time of enrollment
- Regular access to WiFi (for Mightier gameplay device connection)
- Independently elected to engage with Mightier program
Who cannot join
- Previous use of Mightier
- Under the age of 4
- Older then 16 years of age
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Examining the Impact of Adding Printed CBT Materials to a Pediatric Digital Emotional Regulation Intervention
The primary goal of this study is to demonstrate that engaging with "offscreen" physical materials that focus on teaching and practicing Cognitive Behavioral Therapy-based skills alongside a digital emotional regulation intervention results in greater symptom improvement in kids than engaging with the digital intervention alone.
Participants are children who are using Mightier a video-game based heart rate biofeedback intervention used to build emotion regulation. Caregivers will be asked to complete a short survey prior to their child's first play and then complete that survey at 12 weeks post baseline.
The pre-post self-report design, combined with analyses accounting for engagement with offscreen materials will allow the investigators to observe changes during Mightier use and relate those changes to type of program engagement. (edited)
Read the detailed description
Mightier is an app-based biofeedback videogame platform that utilizes heart rate (HR) monitoring during gameplay to teach and facilitate practice of emotional regulation skills in children ages 6-14. The effectiveness of Mightier has been supported through several studies in children ages 8-18, specifically reducing symptoms of aggression, oppositional behavior, and parental stress. The developers of Mightier have recently created "offscreen" physical materials that focus on teaching additional Cognitive Behavioral Therapy (CBT)-based skills and concepts. While these materials are based on empirically supported principles, it remains unclear whether they impart additional clinical benefit when used in conjunction with the validated video game. Investigators seek (1) a better understanding of how offscreen materials may support digital experiences, and (2) to provide preliminary evidence that these specific offscreen experiences provide clinical benefit to families, rather than solely entertainment benefit.
For this proposed study investigators hypothesize the following:
- Caregivers will report family engagement with CBT printed materials.
- Caregivers who indicated high family engagement with printed CBT materials will report larger gains in emotional awareness and emotional regulation than those who did not engage, or engaged minimally, with CBT printed materials.
- Caregivers will report significantly greater feelings of self-efficacy after using the Mightier program.
- Those who reported high family engagement with printed CBT materials will report higher increases in parenting self-efficacy.
For the duration of the 12 week intervention period, participants will play Mightier and engage with CBT-based printed materials ad libitum. They will not receive any special instructions or recommendations outside of those provided to all Mightier families. Consistent with any other family using Mightier, participating families will be free to engage with or deny all programming associated with Mightier (e.g. email updates and other support). All individuals engaging with participating families to facilitate the standard Mightier experience will be blinded to their participation in research.
Participating families will be contacted via email to complete follow-up measures at 12 weeks. Participants will only be sent these emails if they are customers of Mightier at the time of follow up.
- Conditions
- Emotional Regulation
- Being tested
- Mightier
- Keywords
- Emotional Dysregulation, Pediatric, CBT, Digital Intervention
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MightierBehavioural
Mightier is a pediatric at-home intervention program that includes an app-based biofeedback video game that utilizes heart rate (HR) monitoring during game play to teach and facilitate practice of emotional regulation skills in children ages 6-14. The program also uses physical materials including printed workbooks and conversation cards that focus on teaching additional Cognitive Behavioral Therapy (CBT)-based skills and concepts.
| Study group | Role | What they receive |
|---|---|---|
| Mightier | Experimental | Ad lib use of child biofeedback video game play and CBT-based offscreen program materials in home Receives: Behavioral: Mightier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulties in Emotion Regulation Scale-Parent (DERS-P)
The Difficulties in Emotion Regulation Scale--Parent Report (DERS-P) Bunford et al., 2020) was adapted from the Difficulties in Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004) to assess emotion dysregulation (ED) in 11- to 17-year-old youth. There are 36 items that assess parental perceptions of youth without a specified time frame. Parents of children who play Mightier will complete the DERS-P at Baseline and Week 12 by choosing one of the following response categories: Almost never (0-10%), Sometimes (11-35%), About half the time (36-65%), Most of the time (66-90%) or Almost always (91-100%).
Measured: Baseline and Week 12
Secondary outcomes (2)
Brief Parental Self-Efficacy Scale (BPSES)
The Brief Parental Self Efficacy Scale (BPSES) is a 5- item measure of parental self- efficacy. Parental self-efficacy (PSE) "describes a parent's belief in their ability to perform the parenting role successfully. Scores on the BPSES can be used to measure change over time in PSE. Parents of children who play Mightier will complete the BPSES at Baseline and Week 12 indicating how much they agree or disagree with each of the statements over the past month. Response categories for the BPSES include: Strongly Disagree, Disagree, Neural, Agree, or Strongly Disagree
Measured: Baseline and Week 12
Parent Reported Clinical Global Impression- Improvement (CGI-I)
The Parent Reported CGI-I asks the parent to rate their child's emotional regulation since the beginning of Mightier use. Emotional regulation includes emotional awareness, use of strategies, calming behavior changes, ability to pause, use of deep breaths in game or out of game, or any other behaviors that the parent has found notable. Response Categories for the Parent Reported CGI-I include: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, or Very much worse.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start15 Sep 2024 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- As a single arm study all participants will receive a game-based biofeedback intervention with offline CBT-based materials. They are encouraged to engage with the intervention in an entirely self-directed manner. Study analyses will seek to understand the impact of differential engagement with the intervention (offscreen materials + biofeedback vs. biofeedback alone) in a post-hoc manner.
- Masking
- None (open label)
- Enrolment
- 150 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
- NCT06580496
- Sponsor's protocol ID
- 2594
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Adding Printed CBT Materials to a Pediatric Digital Emotional Regulation Intervention
- ClinicalTrials.gov ID
- NCT06580496
- Acronym / sponsor ID
- 2594
- Conditions
- Emotional Regulation
- Keywords
- Emotional Dysregulation, Pediatric, CBT, Digital Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Neuromotion LabsIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 30 Aug 2024 (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 primary goal of this study is to demonstrate that engaging with "offscreen" physical materials that focus on teaching and practicing Cognitive Behavioral Therapy-based skills alongside a digital emotional regulation intervention results in greater symptom improvement in kids than engaging with the digital intervention alone.
Participants are children who are using Mightier a video-game based heart rate biofeedback intervention used to build emotion regulation. Caregivers will be asked to complete a short survey prior to their child's first play and then complete that survey at 12 weeks post baseline.
The pre-post self-report design, combined with analyses accounting for engagement with offscreen materials will allow the investigators to observe changes during Mightier use and relate those changes to type of program engagement. (edited)
Detailed description
Mightier is an app-based biofeedback videogame platform that utilizes heart rate (HR) monitoring during gameplay to teach and facilitate practice of emotional regulation skills in children ages 6-14. The effectiveness of Mightier has been supported through several studies in children ages 8-18, specifically reducing symptoms of aggression, oppositional behavior, and parental stress. The developers of Mightier have recently created "offscreen" physical materials that focus on teaching additional Cognitive Behavioral Therapy (CBT)-based skills and concepts. While these materials are based on empirically supported principles, it remains unclear whether they impart additional clinical benefit when used in conjunction with the validated video game. Investigators seek (1) a better understanding of how offscreen materials may support digital experiences, and (2) to provide preliminary evidence that these specific offscreen experiences provide clinical benefit to families, rather than solely entertainment benefit.
For this proposed study investigators hypothesize the following:
- Caregivers will report family engagement with CBT printed materials.
- Caregivers who indicated high family engagement with printed CBT materials will report larger gains in emotional awareness and emotional regulation than those who did not engage, or engaged minimally, with CBT printed materials.
- Caregivers will report significantly greater feelings of self-efficacy after using the Mightier program.
- Those who reported high family engagement with printed CBT materials will report higher increases in parenting self-efficacy.
For the duration of the 12 week intervention period, participants will play Mightier and engage with CBT-based printed materials ad libitum. They will not receive any special instructions or recommendations outside of those provided to all Mightier families. Consistent with any other family using Mightier, participating families will be free to engage with or deny all programming associated with Mightier (e.g. email updates and other support). All individuals engaging with participating families to facilitate the standard Mightier experience will be blinded to their participation in research.
Participating families will be contacted via email to complete follow-up measures at 12 weeks. Participants will only be sent these emails if they are customers of Mightier at the time of follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- As a single arm study all participants will receive a game-based biofeedback intervention with offline CBT-based materials. They are encouraged to engage with the intervention in an entirely self-directed manner. Study analyses will seek to understand the impact of differential engagement with the intervention (offscreen materials + biofeedback vs. biofeedback alone) in a post-hoc manner.
| Arm | Type | Receives |
|---|---|---|
| Mightier | Experimental | Behavioral: MightierAd lib use of child biofeedback video game play and CBT-based offscreen program materials in home |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 4-16 years old at time of enrollment
- Regular access to WiFi (for Mightier gameplay device connection)
- Independently elected to engage with Mightier program
Key exclusion criteria (3 listed)
- Previous use of Mightier
- Under the age of 4
- Older then 16 years of age
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 |
|---|---|---|
| MightierMightier is a pediatric at-home intervention program that includes an app-based biofeedback video game that utilizes heart rate (HR) monitoring during game play to teach and facilitate practice of emotional regulation skills in children ages 6-14. The program also uses physical materials including printed workbooks and conversation cards that focus on teaching additional Cognitive Behavioral Therapy (CBT)-based skills and concepts. | Behavioural | Mightier |
Primary outcome
Difficulties in Emotion Regulation Scale-Parent (DERS-P)
Time frame: Baseline and Week 12
The Difficulties in Emotion Regulation Scale--Parent Report (DERS-P) Bunford et al., 2020) was adapted from the Difficulties in Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004) to assess emotion dysregulation (ED) in 11- to 17-year-old youth. There are 36 items that assess parental perceptions of youth without a specified time frame. Parents of children who play Mightier will complete the DERS-P at Baseline and Week 12 by choosing one of the following response categories: Almost never (0-10%), Sometimes (11-35%), About half the time (36-65%), Most of the time (66-90%) or Almost always (91-100%).
2 secondary outcomes
Brief Parental Self-Efficacy Scale (BPSES)
Time frame: Baseline and Week 12
Parent Reported Clinical Global Impression- Improvement (CGI-I)
Time frame: Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Link to described intervention to be used in studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Mightier in people with Emotional Regulation, run by Neuromotion Labs.
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 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Alyssa Peechatka, PhD (1-888-978-7495, alyssa@mightier.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulties in Emotion Regulation Scale-Parent (DERS-P) (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.