NCT07147738

Brief Summary

The purpose of this study is to investigate whether the prevention program Kapot Sterk is effective.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

August 15, 2025

Last Update Submit

August 28, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Self-esteem

    will be measured using an instrument based on items from the Dutch version of the Rosenberg Self-Esteem Scale (RSES), developed for a study with children aged 8-12 years. The instrument contains five items (e.g., "I think positively about myself"), rated on a 3-point scale ranging from 1 (not true) to 3 (definitely true). Higher scores reflect greater self-esteem.

    baseline (T0), immediately after the program ended for the intervention group (or after the waiting period for the control group) (T1), and at 3 months post-program (T2).

  • Self-control

    will be measured using five items based on the Brief Self-Control Scale (Tangney et al., 2004) (e.g., "I am good at saying no to things that are hard to resist"). Items are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Items 3 and 4 will be reverse coded so that higher scores reflect higher self-control.

    baseline (T0), immediately after the program ended for the intervention group (or after the waiting period for the control group) (T1), and at 3 months post-program (T2).

  • Peer pressure

    will be measured using ten items based on the Peer Pressure Scale (Sullivan, 2006). The original items have been translated into Dutch and adapted to reflect minor offenses typically committed by juveniles (e.g., "I feel pressure from my friends to steal something from a shop"). Items are rated on a 5-point Likert scale ranging from 1 (absolutely never) to 5 (very often). Higher scores indicate greater levels of experienced peer pressure.

    baseline (T0), immediately after the program ended for the intervention group (or after the waiting period for the control group) (T1), and at 3 months post-program (T2).

Secondary Outcomes (3)

  • Externalizing behavior

    baseline (T0) and at 3 months post-program (T2).

  • Perceived social support from parents, friends, and significant others

    baseline (T0), immediately after the program ended for the intervention group (or after the waiting period for the control group) (T1), and at 3 months post-program (T2).

  • Knowledge of youth work

    baseline (T0), immediately after the program ended for the intervention group (or after the waiting period for the control group) (T1), and at 3 months post-program (T2).

Other Outcomes (6)

  • Demographic, personal, socioeconomic, and family background

    Baseline (T0)

  • Parent-child relationship

    baseline (T0) and at 3 months post-program (T2).

  • Presence of Deviant peers

    baseline (T0) and at 3 months post-program (T2).

  • +3 more other outcomes

Study Arms (2)

experimental group

EXPERIMENTAL

This group will participate in the program Kapot Sterk.

Behavioral: Kapot Sterk (translate as Incredibly Strong)

control group

NO INTERVENTION

This group will not participate in the program. They will receive the program afterwards, once data collection is finished.

Interventions

The program consists of five lessons of approximately 60 minutes long, delivered over a period of four to eight weeks. The lessons are facilitated by trained pedagogical staff (e.g., youth workers), while the school's own teachers are always present during the sessions. Lessons include active learning strategies such as role-playing, group discussions, and reflection exercises, often based on realistic and recognizable scenarios. The program focuses on strengthening key social-emotional skills, such as self-esteem, self-control, and resistance to peer pressure.

experimental group

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Participants are 10-13 years old.
  • Participants attend school.

You may not qualify if:

  • \- Participants are younger than 10 years old or older than 13 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utrecht University

Utrecht, 3584 CS, Netherlands

Location

Study Officials

  • Jessica J Asscher, PhD.

    Utrecht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A cluster RCT will be used to determine the effectiveness of the program Incredibly Strong. Within each school, classes will be randomly assigned to either the experimental group, in which the program starts as soon as possible, or to a waitlist control group, which starts after the follow-up period (three months). Randomization to either the experimental or control group will take place using a computerized randomization in a 1:1 ratio. Classes in the waitlist control group receive the program approximately 5 months later, but still within the same school year, allowing all classes to receive the program.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

August 15, 2025

First Posted

August 29, 2025

Study Start

November 20, 2024

Primary Completion

September 26, 2025

Study Completion

September 26, 2025

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

The data can be shared in anonymized form upon request.

Shared Documents
STUDY PROTOCOL
Time Frame
The data will become available after the completion of the program and data collection.

Locations