Examining the Impacts on In-School Behaviors of In-Home Engagement With a Biofeedback-based Videogame Application
试验速览
- 阶段
- 不适用
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Overall emotional regulation improvement as reported by teacher
研究概览
简要总结
The proposed study aims to investigate the effects of children's in-home engagement with a biofeedback video game-based intervention on children's in-school behaviors. For the proposed study, families with no prior Mightier exposure will engage in online gameplay for eight weeks. Mightier will recruit families through social media and clinical settings, then Mightier will randomly assign participants to one of two groups: a group in which the child participant is encouraged to play Mightier games with biofeedback elements 45 or more minutes a week, broken into 3 or more sessions a week soon after baseline data have been collected, and a group in which the child participant receives Mightier and is invited to play Mightier games with biofeedback elements after all study baseline and follow-up data have been collected. The investigators will aim to enroll 20 parent-child dyads in each group.
Specific Aims and Hypotheses:
- Demonstrate that child engagement in Mightier biofeedback video games is correlated to child improvement in school behaviors. The investigators hypothesize that teachers of child participants will report reductions in child school behavior challenges after 8 weeks of child Mightier gameplay.
- Demonstrate that child engagement in Mightier biofeedback video games is correlated to child improvement in at-home behaviors and general improvement in emotion regulation. The investigators hypothesize that parents of child participants will report a reduction in child behavior challenges and improvements in child emotion regulation after 8 weeks of child Mightier gameplay.
详细描述
Study Design:
A randomized controlled trial comparing pre- and post-measures for a group in which child participants play Mightier video games for the active 8-week study period (Mightier Now group) to a group in which child participants wait during the active 8-week study period, then play Mightier after post-measures are collected (Mightier Later group).
Study Sample:
40 parent-child dyads in which the enrolled children are between 6 and 11 years old, have no prior Mightier experience, and attend school outside the home; 40 school teacher informants, who will complete baseline and follow-up measures on behalf of enrolled children.
Study Aims:
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
- Single (Outcomes Assessor)
盲法说明
Enrolled family random study cohort assignment will be masked from school teachers, who will complete outcome measure questionnaires about enrolled child participants at baseline and follow-up.
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6-11 at the time of screening
- •Attending school outside of the home and not planning to change schools or classrooms during the 8-week study period
排除标准
- •Prior Mightier use
- •Out-of-home School Teacher unable to complete baseline and follow-up questionnaires
- •Planned medication changes during the 8-week study period
- •Parents encouraged to self-exclude if their children have severe skin sensitivities
- •Parents encouraged to self-exclude if their children are pre-readers
结局指标
主要结局
Overall emotional regulation improvement as reported by teacher
时间窗: Week 8
Clinical Global Impressions Scale Improvement Question (CGI-I): The CGI is a self-report question that asks the respondent if they have noticed any overall improvements in the child's emotion regulation, with response options ranging from (1) very much improved to (7) very much worse. The Teacher CGI-I has not been scientifically validated for use in research studies. Teachers of child participants will complete the CGI-I at follow-up.
Overall emotional regulation improvement as reported by parent
时间窗: Week 8
Clinical Global Impressions Scale Improvement Question (CGI-I): The CGI is a self-report question that asks the respondent if they have noticed any overall improvements in the child's emotion regulation, with response options ranging from (1) very much improved to (7) very much worse. The Parent CGI-I has not been scientifically validated for use in research studies. Parents of child participants will complete the CGI-I at follow-up.
Change in in-school problem behaviors from baseline to follow-up
时间窗: Baseline and Week 8
Child Behavior Checklist- Teacher Report Form (CBCL-TRF): The CBCL-TRF (Achenbach \& Rescorla, 2001) assesses child adaptive behaviors and problem behaviors. There are 112 items that assess problem behaviors and 16 items that assess academic performance and adaptive behavior. School teachers of child participants will complete the CBCL-TRF at baseline and Week 8.
Change in in-home problem behaviors from baseline to follow-up
时间窗: Baseline and Week 8
Child Behavior Checklist (CBCL/6-18): The CBCL/6-18 (Achenbach \& Rescorla, 2001) assesses child adaptive behaviors and problem behaviors. There are 112 items that assess problem behaviors and 20 items that assess adaptive behavior. Response format for problem behaviors is from 0 ("not true") to 2 ("very true"). Parent participants will complete the CBCL/6-18 at baseline and follow-up.
Change in irritable mood from baseline to follow-up
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
未报告次要终点