跳至主要内容
临床试验/NCT02766101
NCT02766101已完成不适用

Can a Physical Activity Program Implemented at a Therapeutic School Promote Emotional Regulation and School Success in Socially and Emotionally Vulnerable Children?

Harvard School of Public Health (HSPH)2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2014年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
103
试验地点
2
主要终点
Change in Minutes and Number of Disciplinary Time Out of Class Events (classroom functioning)

研究概览

简要总结

The purpose of this study is to examine whether an exergaming, aerobic physical education (PE) curriculum is acceptable and elicits improvements in behavioral self-regulation and classroom functioning among children with behavioral health challenges attending a therapeutic day school. After following an approved consent/assent process, children attending the school were randomized by classroom to take part in either 7 weeks of the experimental PE curriculum, or 7 weeks of the standard PE curriculum; after a 10 week washout period, children then crossed over into the other arm.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Attending the Manville School at the time of study initiation

排除标准

  • Medical exemption from physical education classes
  • Parental opt out from physical education classes

结局指标

主要结局

Change in Minutes and Number of Disciplinary Time Out of Class Events (classroom functioning)

时间窗: Assessed Daily for 14 weeks (7 weeks in intervention arm and 7 weeks in control arm)

Recording of student number of times and total minutes per day asked to leave the classroom due to disruptive or aggressive behavior. This outcome measure is recorded at the time of event on a mobile survey platform by the present classroom counselor. The measure may be dichotomized into clinical thresholds of time out of class either disruptive or preclusive of learning. A common measurement of classroom functioning in therapeutic school environments.

Change in Conners Abbreviated Teacher Rating Scale score (behavioral dysregulation: impulsivity/emotional lability)

时间窗: Assessed Daily for 14 weeks (7 weeks in intervention arm and 7 weeks in control arm)

Recording of classroom counselor assessment of student impulsivity/hyperactivity and emotional lability using the Conners Abbreviated Teacher Rating Scale 10-item (CATRS-10). CATRS-10 is a commonly used and validated screening instrument for behavioral problems related to inattention, impulsivity/hyperactivity and emotional lability. Classroom counselors completed the CATRS-10 at the end of each school day for each student. The instrument consists of 10 statements regarding the child's behavior rated on a 4-point Likert scale, with a possible total score from 0 to 30. A score of 15 or higher has been the standard for screening children with symptomology at a level of clinical concern.Equivalent screening thresholds were used for the emotional lability subscale (≥6 out of possible 12) and impulsivity subscale (≥9 out of possible 18). Thus this outcome measure can also be dichotomized for analytical and clinical interpretation purposes.

次要结局

未报告次要终点

研究者

发起方
Harvard School of Public Health (HSPH)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kirsten Davison

Associate Professor

Harvard School of Public Health (HSPH)

研究点 (2)

Loading locations...

相似试验

Manville Moves: an Exercise Intervention for... | 临床试验