Examining the Impacts of Parent Mightier Play as a Supplement to Child Mightier Play
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Parent perception of change in child emotion regulation from baseline measured on GIS at Week 8
研究概览
简要总结
A randomized controlled trial comparing a group in which only child participants play Mightier video games for 8 weeks (Child Play group) to a group in which child and parent participants play Mightier video games for 8 weeks (Child and Parent Play group).
详细描述
Mightier is a mobile app-based biofeedback video game platform that facilitates emotion regulation skill-building among children ages 6-14. The technology behind Mightier's mobile app has been validated in two independent sham-controlled randomized controlled trials, where the investigators have seen decreases in clinical symptoms of aggression and disruptive behaviors, as well as lowered family stress without adverse events.
The study utilizes a parallel randomized controlled design comparing groups of participant families whose children play Mightier video games without parent play to groups of participant families in which both children and parents play Mightier video games. Self-report measures will be completed by participant children and parents.
The study consists of three primary phases: Pre-Study, Active Engagement, and Follow-Up. During the Pre-Study Phase, participants will undergo pre-screening and screening to evaluate interest and eligibility for the study, and participants who consent to participate in the study will complete baseline measures and be randomized into treatment groups. Mightier games will be shipped to participants during or shortly after their Pre-Study call. Participants will be instructed to begin Mightier gameplay as soon as Mightier games arrive at their homes, which will begin the Active Engagement Phase of the study.
During the 8-week Active Engagement Phase, participants will be encouraged to play Mightier games in a way that corresponds to their study condition, and they will be offered engagement support in the form of brief weekly check-ins.
After completion of the Active phase, participants will have a brief Follow-up phase, consisting of one video call during which child and parent participants will complete self-report follow-up measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6-12 at the time of screening
- •Regular access to WiFi (for Mightier gameplay device connection)
排除标准
- •Prior Mightier use
- •Diagnosed Intellectual Disability (by history)
- •Planned medication changes during the 8-week study period
结局指标
主要结局
Parent perception of change in child emotion regulation from baseline measured on GIS at Week 8
时间窗: Baseline and Week 8
Global Improvement Scale (GIS): The GIS is a parent self-report question that asks parents if they have noticed any overall improvements in their child's emotion regulation, with response options ranging from (1) very much improved to (7) very much worse. Minimum score = 1, Maximum score = 7, with higher numbers indicating less improvement, or worsening. The GIS has not been scientifically validated. Parent participants will complete the GIS at Week 8.
Change in child behavior and emotion problems measured on BFS at Week 8
时间窗: Baseline and Week 8
Behavior and Feelings Survey (BFS): The BFS (Weisz et al., 2014) is a 12-item scale measuring child behavior and emotion problems. The child's parent is prompted to read the survey questions to the child and to note the child's responses. The researcher will screen share the BFS form and record child responses in the form. Children will complete the BSF at baseline and Week 8. Items are rated on a scale from 0 (not a problem) to 4 (a very big problem). Three scale scores can be derived: Internalizing Problems (sum of items 1-6), Externalizing Problems (sum of items 7-12), and Total Problems (sum of items 1-12).
Change in child irritability from baseline measured on ARI-P at Week 8
时间窗: Baseline and Week 8
Affective Reactivity Index-Parent Report (ARI-P): The ARI is a 7-item scale that consists of 6 symptom items and 1 impairment item. The scale was designed to determine irritable mood rather than behavioral consequences such as hostility and acts of aggression (Stringaris et al., 2012). The individual items are scored 0,1, 2, and only the first six items are summed to form the total score, with a minimum score of 0 and a maximum score of 18, and higher scores indicating greater severity of irritability symptoms. The seventh item is an impairment item and it is analysed separately, with a minimum score of 0 and a maximum score of 3, and higher scores indicating greater irritability symptom severity. Parent participants will complete the ARI-P at baseline and Week 8.
次要结局
- Change in parent emotion regulation from baseline measured on DERS-18 at Week 8(Baseline and Week 8)
- Change in parent beliefs about intervention credibility and effectiveness from baseline, measured on the CEQ-P at Week 4 and Week 8(Baseline, Week 4, and Week 8)
- Change in child-parent relationship from baseline, measured on the CPRS-SF at Week 8(Baseline and Week 8)