NCT02865603

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
708

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

November 2, 2018

Status Verified

November 1, 2018

Enrollment Period

2.1 years

First QC Date

August 4, 2016

Last Update Submit

November 1, 2018

Conditions

Mental Health Wellness 1Mental Disorders

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline, 7 months post-baseline and 19 months post-baseline

Secondary Outcomes (4)

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

    Baseline, 7 months post-baseline and 19 months post-baseline

  • Change in children's behavioral inhibition

    Baseline, 7 months post-baseline

  • Change in teachers' sense of efficacy

    Baseline, 7 months post-baseline and 19 months post-baseline

  • Change in classroom behavior

    Baseline, 7 months post-baseline and 19 months post-baseline

Study Arms (2)

PAX Good Behavior Game

EXPERIMENTAL

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

Waitlist control group

NO INTERVENTION

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.

Interventions

PAX Good Behavior GameBEHAVIORAL

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

PAX Good Behavior Game

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Schools for children with special educational needs and schools with Russian language as instruction language were excluded.
  • Schools with single-sex classrooms were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 31432379DERIVED

  • 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.

    PMID: 29696198DERIVED

Related Links

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Karin Streimann

    National Institute for Health Development

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 12, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

November 2, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share