Effectiveness of a Universal Classroom-based Preventive Intervention (PAX GBG) in Estonia: A Matched-pair Cluster-randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 708
- Primary Endpoint
- Change in children's social and emotional well-being
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •Schools for children with special educational needs and schools with Russian language as instruction language were excluded.
- •Schools with single-sex classrooms were excluded.
Arms & Interventions
PAX Good Behavior Game
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.
Intervention: PAX Good Behavior Game (Behavioral)
Waitlist control group
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.
Outcomes
Primary Outcomes
Change in children's social and emotional well-being
Time Frame: 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).
Secondary Outcomes
- 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)
Investigators
Karin Streimann
Principal Investigator
National Institute for Health Development, Estonia