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Completed

NCT Number: NCT02865603

Impact of PAX Good Behavior Game on Elementary School Students in Estonia

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.

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Key information

Conditions

Mental Health Wellness 1 Mental Disorders

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PAX Good Behavior Game

Behavioral

PAX GBG includes evidence-based kernels and a classroom game where students are reinforced for their mutual success in withholding inappropriate behavior.

Primary outcomes

  1. 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

  1. Change in symptoms of attention deficit hyperactivity disorder (ADHD) among the children

    Time frame: Baseline, 7 months post-baseline and 19 months post-baseline

    The Swanson, Nolan and Pelham-IV Questionnaire (SNAP-IV) (Swanson et al., 2001) is an 18-item instrument for rating ADHD-related symptoms and will be completed by parents.

  2. Change in children's behavioral inhibition

    Time frame: Baseline, 7 months post-baseline

    The effects of the intervention on inhibitory control will be measured using cognitive task (Go/No-Go task). The task will be developed specially for this research and completed by children.

  3. Change in teachers' sense of efficacy

    Time frame: Baseline, 7 months post-baseline and 19 months post-baseline

    Teachers' efficacy will be measured with The Teachers' Sense of Efficacy Scale (TSES; Tschannen-Moran & Hoy, 2001). It is a self-reported measure for teachers that consists of 24 items and assesses the teacher's perception of their sense of effectiveness as a teacher.

  4. Change in classroom behavior

    Time frame: Baseline, 7 months post-baseline and 19 months post-baseline

    Teacher-rated 4-item measure will be used to assess classroom behavior. The measure originates from Organisation for Economic Co-operation and Development (OECD) Teaching and Learning International Survey (TALIS) 2013 teacher's questionnaire (question nr 41) and asks to indicate how strongly does the teacher agree or disagree with statements about the classroom behavior.

Sponsors and collaborators

Lead sponsor

National Institute for Health Development, Estonia

Other Gov

Collaborators

  • European Social Fund
  • Ministry of the Interior, Estonia

Registry information

Official study title

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

Acronym: PAXGBGEE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 12, 2016
Registry last updated
Nov 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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