Adding Printed CBT Materials to a Pediatric Digital Intervention
NCT Number: NCT06580496
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Emotional Regulation
Sponsor: Neuromotion Labs
Sex: ALL
Age: CHILD
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2026-02-15

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 us to observe changes during Mightier use and relate those changes to type of program engagement. (edited)

Primary Outcome Measures: 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 \&amp; 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 Outcome Measures: 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, 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., Week 12
Other Outcome Measures: Self-Reported use of Mightier Materials, At week 12 Parents will be asked to complete a survey with 8 items about the Mightier materials they received and how their child used the materials. There are 5 questions which indicate if the child used Mightier materials and how they used the materials. There are 3 items that ask the parent to indicate how much they agree or disagree with statements about the Mightier materials they used., Week 12