Viewing Study NCT05794893


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Study NCT ID: NCT05794893
Status: COMPLETED
Last Update Posted: 2023-04-03
First Post: 2023-03-08
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Effects of Good Behavior Game in a Swedish Sample
Sponsor: Region Skane
Organization:

Study Overview

Official Title: Good Behavior Game - a Randomized Controlled Study Among Young Children in Swedish Primary Schools.
Status: COMPLETED
Status Verified Date: 2023-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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.
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: