Clinical trial NCT06580496: Adding Printed CBT Materials to a Pediatric Digital Intervention
Official title: Examining the Impact of Adding Printed CBT Materials to a Pediatric Digital Emotional Regulation Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emotional Regulation
Keywords: Emotional Dysregulation
Pediatric
CBT
Digital Intervention
Lead sponsor: Neuromotion Labs
Sponsor class: INDUSTRY
First posted: 2024-08-30
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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:

1. Caregivers will report family engagement with CBT printed materials.
2. 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.
3. Caregivers will report significantly greater feelings of self-efficacy after using the Mightier program.
4. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Previous use of Mightier
* Under the age of 4
* Older then 16 years of age

Primary outcomes:
measure: Difficulties in Emotion Regulation Scale-Parent (DERS-P)
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Brief Parental Self-Efficacy Scale (BPSES)
timeFrame: Baseline and Week 12
measure: Parent Reported Clinical Global Impression- Improvement (CGI-I)
timeFrame: Week 12
Other outcomes:
measure: Self-Reported use of Mightier Materials
timeFrame: Week 12
Locations:
Study officials:
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