Adding Printed CBT Materials to a Pediatric Digital Intervention

NCT06580496 | Not Yet Recruiting

• 1 other identifier: 2594
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Emotional Regulation

Keywords

Emotional Dysregulation; Pediatric; CBT; Digital Intervention

Outcome Measures

Primary Outcomes (1)

• 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%).

  Baseline and Week 12

Secondary Outcomes (2)

• Brief Parental Self-Efficacy Scale (BPSES)

  Baseline and Week 12

• Parent Reported Clinical Global Impression- Improvement (CGI-I)

  Week 12

Other Outcomes (1)

• Self-Reported use of Mightier Materials

  Week 12

Study Arms (1)

Mightier

EXPERIMENTAL

Ad lib use of child biofeedback video game play and CBT-based offscreen program materials in home

Behavioral: Mightier

Interventions

Mightier BEHAVIORAL

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.

Mightier

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Neuromotion Labs: lead

Related Links

• Link to described intervention to be used in study

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Central Study Contacts

Alyssa Peechatka, PhD

CONTACT

1-888-978-7495; alyssa@mightier.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: August 30, 2024
• Study Start: September 15, 2024
• Primary Completion: September 15, 2025
• Study Completion: February 15, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-08