Examining the Impact of Mightier Play on Common Pediatric Symptoms in an Uncontrolled Environment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,732
- 试验地点
- 2
- 主要终点
- Affective Reactivity Index - Parent
研究概览
简要总结
Mightier is a digital mental health tool that uses video game-based heart rate biofeedback to teach emotion regulation. The primary goal of this study is to replicate results from original clinical trials, demonstrating that playing Mightier at home improves common symptoms associated with emotional dysregulation.
Participants will be caregivers of children who are using Mightier, a video-game based heart rate biofeedback intervention. Caregivers will be asked to complete a short survey about their child's emotions and behaviors prior to their child's first play and then complete that survey two more times, at 8 weeks and 12 weeks post baseline.
The pre-post self report design will allow us to observe changes during Mightier use and relate those changes to overall engagement with the intervention
详细描述
Mightier is a video-game-based biofeedback intervention that capitalizes on children's love of video games to increase emotional awareness and facilitate emotion regulation practice through heart rate (HR) control. Each family receives a Mightier Kit (Mighty Band heart rate monitor and dedicated tablet), the Mightier App, online caregiver resources, and dedicated 1-on-1 support from a licensed clinician. 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 core hypothesis underlying Mightier is that learning to regulate autonomic arousal via HR regulation during gameplay will lead to greater emotional regulation capacity. This hypothesis has considerable support, as greater dynamic HR control is associated with greater emotional clarity, emotion regulation, and impulse control in both adults and children.
Although originally created and studied in an academic medical center, it is not well understood how these learnings translate to change in a more diverse population in a less well-controlled environment (i.e. the home) with varying engagement with the intervention. Increased understanding of the Mightier population's behavioral and symptom characteristics, and the interplay between individual characteristics, engagement, HR, and symptom change is imperative to improving the intervention.
For this proposed study, we hypothesize the following:
- Participants will report reduction in symptoms after 12 weeks of Mightier
- Participants will show reduction in median HR during gameplay after 12 weeks of Mightier
a. The magnitude of this change will be greater in externalizing symptoms 3. Change in symptoms will be inversely associated with total playtime such that children who play Mightier more will see the largest change (i.e. reduction) in symptoms 4. Changes in symptoms will be associated with change in median HR during gameplay, such that larger reductions in symptoms will be associated with larger reductions in HR during gameplay
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent or caregivers have a child engaging with the heart rate biofeedback intervention Mightier
排除标准
- 未提供
结局指标
主要结局
Affective Reactivity Index - Parent
时间窗: 12 weeks
The Affective Reactivity Index is a 7 item parent reported measure of irritability. Scores range from 0-12, with higher scores representing greater irritability.
Modified Overt Aggression Scale
时间窗: 12 weeks
The Modified Overt Aggression Scale is a 4 item, caregiver report measure of verbal aggression, physical aggression, aggression against property, and autoaggression. Scores range from 0 to 40, with higher scores indicating more aggression.
次要结局
- Screen for Anxiety Related Emotional Disorders(12 weeks)
- National Institute for Children's Health Quality Vanderbilt Assessment Scale(12 weeks)
研究者
Alyssa Peechatka
Lead Scientist
Neuromotion Labs