Clinical trial NCT02865603: Impact of PAX Good Behavior Game on Elementary School Students in Estonia
Official title: Effectiveness of a Universal Classroom-based Preventive Intervention (PAX GBG) in Estonia: A Matched-pair Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Mental Disorders
Lead sponsor: National Institute for Health Development, Estonia
Sponsor class: OTHER_GOV
Collaborators: name: European Social Fund
name: Ministry of the Interior, Estonia
First posted: 2016-08-12
Enrollment: 708
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in children's social and emotional well-being
timeFrame: Baseline, 7 months post-baseline and 19 months post-baseline
Secondary outcomes:
measure: Change in symptoms of attention deficit hyperactivity disorder (ADHD) among the children
timeFrame: Baseline, 7 months post-baseline and 19 months post-baseline
measure: Change in children's behavioral inhibition
timeFrame: Baseline, 7 months post-baseline
measure: Change in teachers' sense of efficacy
timeFrame: Baseline, 7 months post-baseline and 19 months post-baseline
measure: Change in classroom behavior
timeFrame: Baseline, 7 months post-baseline and 19 months post-baseline
Other outcomes:
Locations:
Study officials:
affiliation: National Institute for Health Development
name: Karin Streimann
role: PRINCIPAL_INVESTIGATOR
References:
citation: Streimann K, Selart A, Trummal A. Effectiveness of a Universal, Classroom-Based Preventive Intervention (PAX GBG) in Estonia: a Cluster-Randomized Controlled Trial. Prev Sci. 2020 Feb;21(2):234-244. doi: 10.1007/s11121-019-01050-0.
citation: Streimann K, Trummal A, Klandorf K, Akkermann K, Sisask M, Toros K, Selart A. Effectiveness of a universal classroom-based preventive intervention (PAX GBG): A research protocol for a matched-pair cluster-randomized controlled trial. Contemp Clin Trials Commun. 2017 Aug 30;8:75-84. doi: 10.1016/j.conctc.2017.08.013. eCollection 2017 Dec.