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

Primary Purpose

Mental Health Wellness 1, Mental Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PAX Good Behavior Game
Sponsored by
National Institute for Health Development, Estonia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Health Wellness 1

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    PAX Good Behavior Game

    Waitlist control group

    Arm Description

    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.

    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 Outcome Measures

    Change in children's social and emotional well-being
    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 Outcome Measures

    Change in symptoms of attention deficit hyperactivity disorder (ADHD) among the children
    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.
    Change in children's behavioral inhibition
    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.
    Change in teachers' sense of efficacy
    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.
    Change in classroom behavior
    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.

    Full Information

    First Posted
    August 4, 2016
    Last Updated
    November 1, 2018
    Sponsor
    National Institute for Health Development, Estonia
    Collaborators
    European Social Fund, Ministry of the Interior, Estonia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02865603
    Brief Title
    Impact of PAX Good Behavior Game on Elementary School Students in Estonia
    Acronym
    PAXGBGEE
    Official Title
    Effectiveness of a Universal Classroom-based Preventive Intervention (PAX GBG) in Estonia: A Matched-pair Cluster-randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2016 (Actual)
    Primary Completion Date
    June 2018 (Actual)
    Study Completion Date
    June 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Institute for Health Development, Estonia
    Collaborators
    European Social Fund, Ministry of the Interior, Estonia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Health Wellness 1, Mental Disorders

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    708 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PAX Good Behavior Game
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Waitlist control group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    PAX Good Behavior Game
    Intervention Description
    PAX GBG includes evidence-based kernels and a classroom game where students are reinforced for their mutual success in withholding inappropriate behavior.
    Primary Outcome Measure Information:
    Title
    Change in children's social and emotional well-being
    Description
    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).
    Time Frame
    Baseline, 7 months post-baseline and 19 months post-baseline
    Secondary Outcome Measure Information:
    Title
    Change in symptoms of attention deficit hyperactivity disorder (ADHD) among the children
    Description
    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.
    Time Frame
    Baseline, 7 months post-baseline and 19 months post-baseline
    Title
    Change in children's behavioral inhibition
    Description
    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.
    Time Frame
    Baseline, 7 months post-baseline
    Title
    Change in teachers' sense of efficacy
    Description
    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.
    Time Frame
    Baseline, 7 months post-baseline and 19 months post-baseline
    Title
    Change in classroom behavior
    Description
    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.
    Time Frame
    Baseline, 7 months post-baseline and 19 months post-baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Karin Streimann
    Organizational Affiliation
    National Institute for Health Development
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31432379
    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.
    Results Reference
    derived
    PubMed Identifier
    29696198
    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.
    Results Reference
    derived
    Links:
    URL
    http://www.terviseinfo.ee/vepa
    Description
    PAX GBG Estonian web page

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