NCT05891067

Brief Summary

The purpose of this study is to investigate whether a classroom-based program promoting a prosocial classroom climate is more effective than treatment-as-usual (control condition).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

May 11, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

April 28, 2023

Last Update Submit

May 7, 2024

Conditions

Outcome Measures

Primary Outcomes (8)

  • Change in prosocial behavior as an injunctive form assessed with three items specifically developed for this study

    It is a self-reported instrument rated on a 3-point scale from 1 (not true) to 3 (definitely true), measuring children's attitudes towards prosocial behavior that are on average held in the classroom. Higher scores reflect a higher injunctive norm of the group towards prosocial behavior.

    T1 (baseline); T2 (mid-intervention) approximately 5 months after the start of the intervention; T3 (postintervention) approximately 10 months after the start of the intervention

  • Change in individual prosocial behavior assessed with four items based on the subscale prosocial behavior of the Strengths and Difficulties Questionnaire

    The adapted SDQ subscale prosocial behavior is a self-reported instrument rated on a 4-point scale from 1 (never) to 4 (always). Higher scores reflect more prosocial behavior.

    T1 (baseline); T2 (mid-intervention) approximately 5 months after the start of the intervention; T3 (postintervention) approximately 10 months after the start of the intervention

  • Change in prosocial relations in the classroom assessed with sociometric nominations

    Children see a list with the names of all classmates and select the classmates that fit the question best according to them. Two items are used, assessing the child's prosocial behavior according to classmates. The number of received nominations is devided by the number of possible nominations, resulting in a proportion score for prosocial relations.

    T1 (baseline); T2 (mid-intervention) approximately 5 months after the start of the intervention; T3 (postintervention) approximately 10 months after the start of the intervention

  • Change in cooperation and conflict in the classroom assessed with the Classroom Peer Context Questionnaire (CPCQ), subscales cooperation and conflict.

    The CPCQ is a self-reported instrument. The cooperation subscale consists of four items assessing the extent to which children experience positive behavior. The conflict subscale consists of two items assessing the extent to which children experience negative behavior. The items are rated on a 4-point scale ranging from 1 (not true) to 4 (completely true). Higher scores on the cooperation subscale reflects more positive behavior, while for the conflict subscale it reflects more negative behavior.

    T1 (baseline); T2 (mid-intervention) approximately 5 months after the start of the intervention; T3 (postintervention) approximately 10 months after the start of the intervention

  • Change in intrinsic (prosocial) motivation assessed with four items specifically developed for this study

    This instrument is a self-reported instrument, rated on a 3-point scale ranging from 1 (not true) to 3 (definitely true). Higher scores reflect more intrinsic (prosocial) motivation.

    T1 (baseline); T2 (mid-intervention) approximately 5 months after the start of the intervention; T3 (postintervention) approximately 10 months after the start of the intervention

  • Change in social competence assessed with five items based on the Rosenberg Self-Esteem Scale (RSES)

    The adapted RSES is a self-reported istrument, rated on a 3-point scale ranging from 1 (not true) to 3 (definitely true). Higher scores reflect more social competence.

    T1 (baseline); T2 (mid-intervention) approximately 5 months after the start of the intervention; T3 (postintervention) approximately 10 months after the start of the intervention

  • Change in social autonomy assessed with five items based on the School as a Caring Community Profile-II (SCCP-II) and the Child Development Project

    It is a self-reported instrument, rated on a 4-point scale ranging from 1 (never) to 4 (always). Higher scores reflect more autonomy.

    T1 (baseline); T2 (mid-intervention) approximately 5 months after the start of the intervention; T3 (postintervention) approximately 10 months after the start of the intervention

  • Change in social relatedness assessed with the Classroom Peer Context Questionnaire (CPCQ), subscales comfort and cohesion.

    The CPCQ is a self-reported instrument. The comfort subscale consists of four items assessing the extent to which children feel at ease in the classroom. The cohesion subscale consists of two items assessing the extent to which the children in the classroom spend time together. The items are rated on a 4-point scale ranging from 1 (not true) to 4 (completely true). Higher scores on both subscales reflect more positive behavior.

    T1 (baseline); T2 (mid-intervention) approximately 5 months after the start of the intervention; T3 (postintervention) approximately 10 months after the start of the intervention

Secondary Outcomes (7)

  • Change in school wellbeing assessed with seven items specifically developed for this study

    T1 (baseline); T2 (mid-intervention) approximately 5 months after the start of the intervention; T3 (postintervention) approximately 10 months after the start of the intervention

  • Change in school wellbeing assessed with one item specifically developed for this study

    T1 (baseline); T2 (mid-intervention) approximately 5 months after the start of the intervention; T3 (postintervention) approximately 10 months after the start of the intervention

  • Change in social position (kindness, leadership, unkindness, popularity, best friends) assessed with sociometric nominations

    T1 (baseline); T2 (mid-intervention) approximately 5 months after the start of the intervention; T3 (postintervention) approximately 10 months after the start of the intervention

  • Change in bullying and bullying victimization assessed with the Olweus Bully-Victim Questionnaire (OB-VQ)

    T1 (baseline); T2 (mid-intervention) approximately 5 months after the start of the intervention; T3 (postintervention) approximately 10 months after the start of the intervention

  • Change in bullying and bullying victimization (where child is victimized) assessed with the Olweus Bully-Victim Questionnaire (OB-VQ)

    T1 (baseline); T2 (mid-intervention) approximately 5 months after the start of the intervention; T3 (postintervention) approximately 10 months after the start of the intervention

  • +2 more secondary outcomes

Other Outcomes (6)

  • Child characteristics assessed with items specifically developed for this study

    T1 (baseline)

  • Teacher characteristics assessed with items specifically developed for this study

    T1 (baseline)

  • School characteristics assessed with items specifically developed for this study

    T1 (baseline)

  • +3 more other outcomes

Study Arms (2)

SterkWerk

EXPERIMENTAL

SterkWerk is a classroom-based approach (throughout the school year) for primary school groups 5-8 (children aged 8-12 years old) in which children are given specific roles to actively work on responsibility, ownership and prosocial behavior. SterkWerk consists of three main components: meaningful roles, classroom meeting and compliments.

Behavioral: SterkWerk

Treatment-as-usual

ACTIVE COMPARATOR

Schools in the control group do not receive the intervention (do not receive material or training), and function as normal (treatment-as-usual). Control schools are requested to not start any social-emotional program during the school year 2023/2024.

Behavioral: Treatment-as-usual

Interventions

SterkWerkBEHAVIORAL

Classroom-based intervention program

SterkWerk

Active control group

Also known as: TAU
Treatment-as-usual

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primary school children of grades 5-8 (mostly aged between 8-12 years)
  • Teachers and school leaders of participating schools (no age limit)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utrecht University

Utrecht, 3584CS, Netherlands

Location

Related Publications (1)

  • van Loon AWG, Kaufman TML. The effectiveness of the Dutch Meaningful Roles program in children: a study protocol for a cluster randomized controlled study. BMC Public Health. 2023 Jul 27;23(1):1440. doi: 10.1186/s12889-023-16362-8.

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Tessa Kaufman, dr.

    Utrecht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The design of the current study is a cluster Randomized Controlled Trial (RCT) with two conditions: the intervention condition and a waitlist control condition (TAU: treatment-as-usual). Schools are randomized into the intervention or control condition.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoc

Study Record Dates

First Submitted

April 28, 2023

First Posted

June 6, 2023

Study Start

May 11, 2023

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

The datasets generated during and/or analysed during the current study will be stored in a publicly available repository.

Shared Documents
STUDY PROTOCOL
Time Frame
The data will become available after the completion of the program and data collection.
Access Criteria
The data will become publicly available
More information

Locations