Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2018
Source National Institute for Health Development, Estonia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

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.

Study Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
National Institute for Health Development, Estonia European Social Fund, Ministry of the Interior, Estonia

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT05080777 - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems N/A
Recruiting NCT06012149 - Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry N/A
Recruiting NCT03222375 - SQUEDâ„¢ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism N/A
Active, not recruiting NCT02836080 - Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT) N/A
Active, not recruiting NCT02907658 - Efficacy of Internet Use Disorder Prevention N/A
Completed NCT02710344 - Using Telehealth to Improve Psychiatric Symptom Management N/A
Enrolling by invitation NCT02487888 - A Study of the Impact of Genetic Testing on Clinical Decision Making and Patient Care N/A
Recruiting NCT02292056 - Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions N/A
Active, not recruiting NCT02761733 - The Effectiveness of a Decision-Support Tool for Adult Consumers With Mental Health Needs and Their Care Managers N/A
Completed NCT01947283 - Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation N/A
Completed NCT01690013 - Life Quality and Health in Patients With Klinefelter Syndrome N/A
Completed NCT01633138 - Performance-based Reinforcement to Enhance Cognitive Remediation Therapy N/A
Completed NCT01415323 - Agitation in the Acute Psychiatric Department
Completed NCT01656707 - Adaptive Treatment for Adolescent Cannabis Use Disorders N/A
Completed NCT01701765 - Outcomes and Discharge of Long-stay Psychiatric Patients N/A
Completed NCT00375167 - Efficacy of the Recovery Workbook as a Psychoeducational Tool for Facilitating Recovery N/A
Terminated NCT00757497 - Transcranial Direct Current Brain Stimulation to Treat Patients With Childhood-Onset Schizophrenia Phase 1
Terminated NCT03527550 - Cognitive Control Training for Urgency in a Naturalistic Clinical Setting N/A
Withdrawn NCT03518996 - Non-Invasive Brain Stimulation and Delirium N/A