Mental Disorders Clinical Trial
— PAXGBGEEOfficial title:
Effectiveness of a Universal Classroom-based Preventive Intervention (PAX GBG) in Estonia: A Matched-pair Cluster-randomized Controlled Trial
NCT number | NCT02865603 |
Other study ID # | T90-C305 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | June 2018 |
Verified date | November 2018 |
Source | National Institute for Health Development, Estonia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 708 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 8 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Institute for Health Development, Estonia | European Social Fund, Ministry of the Interior, Estonia |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Baseline, 7 months post-baseline and 19 months post-baseline | |
Secondary | 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. | Baseline, 7 months post-baseline | |
Secondary | 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. | Baseline, 7 months post-baseline and 19 months post-baseline | |
Secondary | 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. | Baseline, 7 months post-baseline and 19 months post-baseline |
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