Effects of Good Behavior Game in a Swedish Sample

March 31, 2023 updated by: Region Skane

Good Behavior Game - a Randomized Controlled Study Among Young Children in Swedish Primary Schools.

This project seeks to study the impact of Good Behavior Game (GBG), a behavior management program, on classroom environment and problem behavior in K-3 classrooms.

The goal of this randomized trial is to study the impact of Good Behavior Game (GBG), a behavior management program, on classroom environment and problem behavior in K-3 classrooms in Sweden. The main question it aims to answer is:

• Does GBG decrease problem behaviors in K-3 classrooms?

Teachers in the intervention group will be trained in GBG and asked to implement it in their respective classrooms. Teachers in the comparison group will provide usual practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: Early conduct problems are prevalent and a prominent risk factor for several adverse health-related and psychosocial outcomes in later life. Good Behavior Game (GBG) is a promising school-based behavior management program with the potential of reaching many children in their formative years.

Primary objective: To study the effectiveness of Good Behavior Game in reducing problem behaviors in Swedish K-3 classrooms under real-world conditions.

Secondary objectives: To investigate changes in problem behaviors in common school areas, classroom climate, teacher collective efficacy, on-task behavior, and behavioral management practices as a result of teacher training in GBG. The study also seeks to investigate implementation as a moderator, as well as potential barriers and facilitators in regards to implementation.

Type of trial: Cluster-randomized controlled trial

Trial design and methods: Recruitment of schools in a Swedish municipality started early 2021. In May 2021, 5 schools were randomized to either intervention group or wait-list (service-as-usual). Data collection started in August 2021 and ended in June 2022. The intervention group received training in GBG from September 2021 to May 2022 by certified trainers who also collected fidelity data through observations throughout the school year. Teacher ratings and observer data was collected at baseline (August 2021), along with a first (November 2021) and second follow-up (May 2022, primary endpoint) throughout the first school year of implementation.

Statistical methodology and analysis: Statistical analysis will primarily include frequentist intent-to-treat analysis, and comparisons of estimates with a corresponding Bayesian model using weakly informative priors.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden
        • Johannesskolan
      • Malmö, Sweden
        • Klagshamnsskolan
      • Malmö, Sweden
        • Malmö friskola
      • Malmö, Sweden
        • Monbijouskolan
      • Malmö, Sweden
        • Ängsdals skola

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eligibility is based on school or classroom level factors. Schools must have at least one classroom with a group of students enrolled in grades K, 1, 2, or 3.

Exclusion Criteria:

  • Special education classrooms are not eligible, though inclusive classrooms with a minority of students needing special education can be included.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Good Behavior Game
28 classes receiving Good Behavior Game intervention
Behavioral: Good Behavior Game
Universal school-based intervention reinforcing prosocial behaviors and discouraging disruptive behaviors in young students.
No Intervention: Service-as-usual
16 classes receiving usual classroom teaching

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Teacher-rated problem behavior in the classroom
Time Frame: Baseline
A teacher-rated scale listing 20 common problem behaviors in the classroom. The teachers bases their ratings on the week before. Every item is rated on a scale from 0 (no times last week) to 4 (several times a day).
Baseline
Teacher-rated problem behavior in the classroom
Time Frame: 3 months
A teacher-rated scale listing 20 common problem behaviors in the classroom. The teachers bases their ratings on the week before. Every item is rated on a scale from 0 (no times last week) to 4 (several times a day).
3 months
Teacher-rated problem behavior in the classroom
Time Frame: 9 months (primary endpoint)
A teacher-rated scale listing 20 common problem behaviors in the classroom. The teachers bases their ratings on the week before. Every item is rated on a scale from 0 (no times last week) to 4 (several times a day).
9 months (primary endpoint)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Classroom Atmosphere Measure
Time Frame: Baseline

Measure of 10 different behavioral classroom factors rated by an independent observer after 30 minutes of observing a classroom. The observer scores every item on a scale from 1-5, were 1 is generally considered very low and 5 is considered very high. A rating of 0 is used when the item/factor is not applicable or possible to rate. The following items are rated:

  1. Students' level of compliance during structured time
  2. Students seem to handle transitions well
  3. Students consistently follow rules appropriate to settings
  4. Students' level of cooperation
  5. Students attempt problem-solving
  6. Students express feelings appropriately
  7. Students' level of interest/enthusiasm/involvement
  8. Classroom is focused and on-task
  9. Classroom responsive to individual differences in students' needs, feelings, etc.
  10. Classroom is supportive of students' efforts
Baseline
Classroom Atmosphere Measure
Time Frame: 3 months

Measure of 10 different behavioral classroom factors rated by an independent observer after 30 minutes of observing a classroom. The observer scores every item on a scale from 1-5, were 1 is generally considered very low and 5 is considered very high. A rating of 0 is used when the item/factor is not applicable or possible to rate. The following items are rated:

  1. Students' level of compliance during structured time
  2. Students seem to handle transitions well
  3. Students consistently follow rules appropriate to settings
  4. Students' level of cooperation
  5. Students attempt problem-solving
  6. Students express feelings appropriately
  7. Students' level of interest/enthusiasm/involvement
  8. Classroom is focused and on-task
  9. Classroom responsive to individual differences in students' needs, feelings, etc.
  10. Classroom is supportive of students' efforts
3 months
Classroom Atmosphere Measure
Time Frame: 9 months

Measure of 10 different behavioral classroom factors rated by an independent observer after 30 minutes of observing a classroom. The observer scores every item on a scale from 1-5, were 1 is generally considered very low and 5 is considered very high. A rating of 0 is used when the item/factor is not applicable or possible to rate. The following items are rated:

  1. Students' level of compliance during structured time
  2. Students seem to handle transitions well
  3. Students consistently follow rules appropriate to settings
  4. Students' level of cooperation
  5. Students attempt problem-solving
  6. Students express feelings appropriately
  7. Students' level of interest/enthusiasm/involvement
  8. Classroom is focused and on-task
  9. Classroom responsive to individual differences in students' needs, feelings, etc.
  10. Classroom is supportive of students' efforts
9 months
Classroom Environment Scale
Time Frame: Baseline
Teacher rates 15 items about the classroom climate (e.g. how well students cooperate, task-orientation etc.). The items are rated on a 0-3 likert scale, some being reverse-coded.
Baseline
Classroom Environment Scale
Time Frame: 9 months
Teacher rates 15 items about the classroom climate (e.g. how well students cooperate, task-orientation etc.). The items are rated on a 0-3 likert scale, some being reverse-coded.
9 months
On-task behavior: Planned activity check/PLACHECK
Time Frame: Baseline
Group-based measure of on task behavior in classroom. Rated by an independent assessor. Score is based on number of children on-task divided by total number of children in the classroom. On-task behavior is rated after 3-minute intervals for a total of 18 minutes. An average of the percentage scores is used as an outcome.
Baseline
On-task behavior: Planned activity check/PLACHECK
Time Frame: 3 months
Group-based measure of on task behavior in classroom. Rated by an independent assessor. Score is based on number of children on-task divided by total number of children in the classroom. On-task behavior is rated after 3-minute intervals for a total of 18 minutes. An average of the percentage scores is used as an outcome.
3 months
On-task behavior: Planned activity check/PLACHECK
Time Frame: 9 months
Group-based measure of on task behavior in classroom. Rated by an independent assessor. Score is based on number of children on-task divided by total number of children in the classroom. On-task behavior is rated after 3-minute intervals for a total of 18 minutes. An average of the percentage scores is used as an outcome.
9 months
Teacher-rated problem behavior in school
Time Frame: Baseline
A teacher-rated scale listing 20 common problem behaviors in the school's common/shared areas. The teachers bases their ratings on the week before. Every item is rated on a scale from 0 (no times last week) to 4 (several times a day).
Baseline
Teacher-rated problem behavior in school
Time Frame: 3 months
A teacher-rated scale listing 20 common problem behaviors in the school's common/shared areas. The teachers bases their ratings on the week before. Every item is rated on a scale from 0 (no times last week) to 4 (several times a day).
3 months
Teacher-rated problem behavior in school
Time Frame: 9 months
A teacher-rated scale listing 20 common problem behaviors in the school's common/shared areas. The teachers bases their ratings on the week before. Every item is rated on a scale from 0 (no times last week) to 4 (several times a day).
9 months
Collective teacher efficacy
Time Frame: Baseline
Teacher rates 12 items on the perceived efficacy of teachers as a collective being able to teach the students attending the school. Items are rated on a 0-5 likert scale, some being reverse-coded.
Baseline
Collective teacher efficacy
Time Frame: 9 months
Teacher rates 12 items on the perceived efficacy of teachers as a collective being able to teach the students attending the school. Items are rated on a 0-5 likert scale, some being reverse-coded.
9 months
Positive behavior support
Time Frame: Baseline
The teacher rates 9 items on their own use of several practices that aim to increase desirable behaviors in the classroom. The teacher will report based on the last 30 days. The items can be rated on a scale from 0 (0 times) to 7 (more than 20 times).
Baseline
Positive behavior support
Time Frame: 9 months
The teacher rates 9 items on their own use of several practices that aim to increase desirable behaviors in the classroom. The teacher will report based on the last 30 days. The items can be rated on a scale from 0 (0 times) to 7 (more than 20 times).
9 months
Behavioral correction
Time Frame: Baseline
The teacher rates 8 items on their own use of several practices that aim to punish, reduce or correct undesirable behaviors in the classroom. The teacher will report based on the last 30 days. The items can be rated on a scale from 0 (0 times) to 7 (more than 20 times).
Baseline
Behavioral correction
Time Frame: 9 months
The teacher rates 8 items on their own use of several practices that aim to punish, reduce or correct undesirable behaviors in the classroom. The teacher will report based on the last 30 days. The items can be rated on a scale from 0 (0 times) to 7 (more than 20 times).
9 months
Observed general praise
Time Frame: Baseline
An independent observer counts the number of times the teacher uses general praise towards one or more students by the teacher. General praise counts as praise were the behavior eliciting praise is not specified, for example "good job". Can also be non-verbal. The observation and counting lasts for 30 minutes.
Baseline
Observed general praise
Time Frame: 3 months
An independent observer counts the number of times the teacher uses general praise towards one or more students by the teacher. General praise counts as praise were the behavior eliciting praise is not specified, for example "good job". Can also be non-verbal. The observation and counting lasts for 30 minutes.
3 months
Observed general praise
Time Frame: 9 months
An independent observer counts the number of times the teacher uses general praise towards one or more students by the teacher. General praise counts as praise were the behavior eliciting praise is not specified, for example "good job". Can also be non-verbal. The observation and counting lasts for 30 minutes.
9 months
Observed specific praise
Time Frame: Baseline
An independent observer counts the number of times behavioral specific praise is used towards one or more students by the teacher. Behavioral specific praise counts as praise or feedback that also entails a description of the behavior eliciting praise, such as "good work reading that out loud". The observation and counting lasts for 30 minutes.
Baseline
Observed specific praise
Time Frame: 3 months
An independent observer counts the number of times behavioral specific praise is used towards one or more students by the teacher. Behavioral specific praise counts as praise or feedback that also entails a description of the behavior eliciting praise, such as "good work reading that out loud". The observation and counting lasts for 30 minutes.
3 months
Observed specific praise
Time Frame: 9 months
An independent observer counts the number of times behavioral specific praise is used towards one or more students by the teacher. Behavioral specific praise counts as praise or feedback that also entails a description of the behavior eliciting praise, such as "good work reading that out loud". The observation and counting lasts for 30 minutes.
9 months
Observed reprimands
Time Frame: Baseline
An independent observer counts the number of times reprimands are used towards one or more students by the teacher. Reprimands are verbal or non-verbal cues were the teacher demands on students ceasing a certain behavior or otherwise point out a behavior that should not be occuring. The observation and counting lasts for 30 minutes.
Baseline
Observed reprimands
Time Frame: 3 months
An independent observer counts the number of times reprimands are used towards one or more students by the teacher. Reprimands are verbal or non-verbal cues were the teacher demands on students ceasing a certain behavior or otherwise point out a behavior that should not be occuring. The observation and counting lasts for 30 minutes.
3 months
Observed reprimands
Time Frame: 9 months
An independent observer counts the number of times reprimands are used towards one or more students by the teacher. Reprimands are verbal or non-verbal cues were the teacher demands on students ceasing a certain behavior or otherwise point out a behavior that should not be occuring. The observation and counting lasts for 30 minutes.
9 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Implementation barriers and facilitators
Time Frame: Baseline
A teacher rates 14 items drawn from the Consolidated Framework for Implementation Research (CFIR). The instrument itself is called The Barrier Buster Tool. The instrument primarily measures contextual factors that are thought to affect implementation and fidelity of a method being implemented. Every item has two ratings. First rating scores if the statement is a barrier (0), neutral (1) or facilitating factor (2). The second column rates the strength of the factor, i.e., if the factor is considered to have a weak/no effect (0) or strong effect (1). Only measured in the experimental group receiving GBG.
Baseline
Implementation barriers and facilitators
Time Frame: 3 months
A teacher rates 14 items drawn from the Consolidated Framework for Implementation Research (CFIR). The instrument itself is called The Barrier Buster Tool. The instrument primarily measures contextual factors that are thought to affect implementation and fidelity of a method being implemented. Every item has two ratings. First rating scores if the statement is a barrier (0), neutral (1) or facilitating factor (2). The second column rates the strength of the factor, i.e., if the factor is considered to have a weak/no effect (0) or strong effect (1). Only measured in the experimental group receiving GBG.
3 months
Implementation barriers and facilitators
Time Frame: 9 months
A teacher rates 14 items drawn from the Consolidated Framework for Implementation Research (CFIR). The instrument itself is called The Barrier Buster Tool. The instrument primarily measures contextual factors that are thought to affect implementation and fidelity of a method being implemented. Every item has two ratings. First rating scores if the statement is a barrier (0), neutral (1) or facilitating factor (2). The second column rates the strength of the factor, i.e., if the factor is considered to have a weak/no effect (0) or strong effect (1). Only measured in the experimental group receiving GBG.
9 months
Average fidelity of implementation
Time Frame: Monthly observations from baseline to 9 months
The trainers responsible for coaching in GBG observes and rates to what extent teachers are following the manual during GBG-sessions. The trainers used standardized observation forms detailing several components of a GBG session, such as setting rules and announcing the time frame. Scores will be based on number of items that the trainer rates as completed, divided by the maximum number of items possible to complete in a session. The average score is then calculated from all sessions.
Monthly observations from baseline to 9 months
Certification in GBG
Time Frame: 9 months
A certification of completing training and performing GBG with fidelity as assessed by trainers. A score of 0 means the teacher has not been certified at the end of the school year. A score of 1 means the teacher has been certified at the end of the school year. The requirements for certification are: participating in all 3 workshops, conducting at least 60 sessions, being observed and receiving feedback at least 9 times with the trainers assessing the sessions as having high enough fidelity.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Skane

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lund University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Björn Hofvander, Lund University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 14, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-06804

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study does not collect individual participant data. Only group/aggregated data is collected. This data may be made available to other researchers unless conflicting with regulations, consent or other aspects of the ethical review.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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