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临床试验/NCT02865603
NCT02865603已完成不适用

Effectiveness of a Universal Classroom-based Preventive Intervention (PAX GBG) in Estonia: A Matched-pair Cluster-randomized Controlled Trial

National Institute for Health Development, Estonia0 个研究点目标入组 708 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
708
主要终点
Change in children's social and emotional well-being

研究概览

简要总结

The aim of this study is to measure the impact of the intervention (PAX GBG) in Estonian-language 1st grade classrooms on students' mental health and behaviour, and teacher's self-efficacy.

详细描述

2-year, matched-pair, cluster-randomized controlled trial with a intervention and wait-list control arm is conducted during school years 2016/17 and 2017/18. 42 volunteering schools were matched to pairs. One school in each pair was randomly selected to receive the PAX GBG or continue their normal activities without intervention. After a post-test assessment in spring 2018 the control group teachers are trained and supported to implement PAX GBG.

研究设计

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

入排标准

年龄范围
6 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All schools with first grade classrooms and Estonian-language as instruction language in Estonia were qualified to take part of the study if they did fit the inclusion criteria.
  • Schools were suitable to participate if they:
  • Had equal to or more than 13 pupils in the first grade classroom in 2016/17 school term;
  • Did not implement any other evidence-based program in basic school stage 1 (grades 1-3), (for example KiVa bullying prevention program);
  • Did not already implement PAX GBG;
  • Had at least one first grade teacher who volunteers to participate for the whole study period of two years.

排除标准

  • Schools for children with special educational needs and schools with Russian language as instruction language were excluded.
  • Schools with single-sex classrooms were excluded.

研究组 & 干预措施

PAX Good Behavior Game

Experimental

The intervention is delivered by teachers within the normal school curriculum. Teachers from intervention classes completed 3-day training and were supported by the mentor, who visited their class during the 2016/17 school year and provided counseling via e-mail and phone. During the second year (2017/18) teachers could use the PAX GBG methods, but they did not receive additional support from the mentors.

干预措施: PAX Good Behavior Game (Behavioral)

Waitlist control group

No Intervention

Control group continue their normal activities without intervention. After a post-test assessment in spring 2018 the control group teachers will be trained and supported to implement PAX GBG.

结局指标

主要结局

Change in children's social and emotional well-being

时间窗: Baseline, 7 months post-baseline and 19 months post-baseline

Children's social and emotional well-being will be measured by the teacher-completed Strengths and Difficulties Questionnaire with impact supplement (SDQ; Goodman, 1999) and parent-rated Strengths and Difficulties Questionnaire (Goodman, 1997).

次要结局

  • Change in symptoms of attention deficit hyperactivity disorder (ADHD) among the children(Baseline, 7 months post-baseline and 19 months post-baseline)
  • Change in teachers' sense of efficacy(Baseline, 7 months post-baseline and 19 months post-baseline)
  • Change in children's behavioral inhibition(Baseline, 7 months post-baseline)
  • Change in classroom behavior(Baseline, 7 months post-baseline and 19 months post-baseline)

研究者

发起方
National Institute for Health Development, Estonia
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Karin Streimann

Principal Investigator

National Institute for Health Development, Estonia

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