Examining the Impact of Adding Printed CBT Materials to a Pediatric Digital Emotional Regulation Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Difficulties in Emotion Regulation Scale-Parent (DERS-P)
研究概览
简要总结
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)
详细描述
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. We 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 we 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Previous use of Mightier
- •Under the age of 4
- •Older then 16 years of age
结局指标
主要结局
Difficulties in Emotion Regulation Scale-Parent (DERS-P)
时间窗: 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%).
次要结局
- Brief Parental Self-Efficacy Scale (BPSES)(Baseline and Week 12)
- Parent Reported Clinical Global Impression- Improvement (CGI-I)(Week 12)
