Mental Health Wellness 1PAXGBGEENCT02865603
Impact of PAX Good Behavior Game on Elementary School Students in Estonia
A study testing PAX Good Behavior Game in people with Mental Health Wellness 1 and Mental Disorders, run by National Institute for Health Development, Estonia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1, Mental Disorders
- What is being tested?
- PAX Good Behavior Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 708 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Schools for children with special educational needs and schools with Russian language as instruction language were excluded.
- Schools with single-sex classrooms were excluded.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health Wellness 1, Mental Disorders
- Being tested
- PAX Good Behavior Game
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAX Good Behavior GameBehavioural
PAX GBG includes evidence-based kernels and a classroom game where students are reinforced for their mutual success in withholding inappropriate behavior.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: Baseline, 7 months post-baseline and 19 months post-baseline
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.
Measured: Baseline, 7 months post-baseline
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.
Measured: Baseline, 7 months post-baseline and 19 months post-baseline
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.
Measured: Baseline, 7 months post-baseline and 19 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 708 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Health Development, Estonia
- Sponsor type
- Other government
- Collaborators
- European Social Fund, Ministry of the Interior, Estonia
- Responsible party
- Principal investigator, Karin Streimann, National Institute for Health Development, Estonia
- Investigators
- Karin Streimann, Principal investigator, National Institute for Health Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865603
- Sponsor's protocol ID
- T90-C305
- Acronym
- PAXGBGEE
- Status last verified
- Nov 2018
- First submitted
- 4 Aug 2016
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31432379Streimann 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.
PubMed 29696198
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Universal Classroom-based Preventive Intervention (PAX GBG) in Estonia: A Matched-pair Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02865603
- Acronym / sponsor ID
- PAXGBGEE / T90-C305
- Conditions
- Mental Health Wellness 1, Mental Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 708 participants (actual)
- Lead sponsor
- National Institute for Health Development, EstoniaOther government
- Collaborators
- European Social Fund, Ministry of the Interior, Estonia
- Study start
- May 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAX Good Behavior Game | Experimental | Behavioral: PAX Good Behavior GameThe 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. |
| 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. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (2 listed)
- Schools for children with special educational needs and schools with Russian language as instruction language were excluded.
- Schools with single-sex classrooms were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAX Good Behavior GamePAX GBG includes evidence-based kernels and a classroom game where students are reinforced for their mutual success in withholding inappropriate behavior. | Behavioural | PAX Good Behavior Game |
Primary outcome
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).
4 secondary outcomes
Change in symptoms of attention deficit hyperactivity disorder (ADHD) among the children
Time frame: Baseline, 7 months post-baseline and 19 months post-baseline
Change in children's behavioral inhibition
Time frame: Baseline, 7 months post-baseline
Change in teachers' sense of efficacy
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Derived from this study: PubMed 31432379Streimann 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.
- Derived from this study: PubMed 29696198Streimann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Streimann principal investigator
National Institute for Health Development
Questions about this trial
What is this clinical trial studying?
A study testing PAX Good Behavior Game in people with Mental Health Wellness 1 and Mental Disorders, run by National Institute for Health Development, Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in children's social and emotional well-being (time frame: Baseline, 7 months post-baseline and 19 months post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02865603, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018.