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

November 1, 2018 updated by: Karin Streimann, National Institute for Health Development, Estonia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

708

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: PAX Good Behavior Game
PAX GBG includes evidence-based kernels and a classroom game where students are reinforced for their mutual success in withholding inappropriate behavior.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, 7 months post-baseline and 19 months post-baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 7 months post-baseline and 19 months post-baseline
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.
Baseline, 7 months post-baseline
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.
Baseline, 7 months post-baseline and 19 months post-baseline
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.
Baseline, 7 months post-baseline and 19 months post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute for Health Development, Estonia

Collaborators

European Social Fund
Ministry of the Interior, Estonia

Investigators

  • Principal Investigator: Karin Streimann, National Institute for Health Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 12, 2016

Study Record Updates

Last Update Posted (Actual)

November 2, 2018

Last Update Submitted That Met QC Criteria

November 1, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T90-C305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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