Child BehaviorNCT05891067
The Effectiveness of a Classroom-based Intervention Promoting a Prosocial Classroom Climate in Children
A study testing SterkWerk and Treatment-as-usual in people with Child Behavior, run by Utrecht University at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Child Behavior
- What is being tested?
- SterkWerk and Treatment-as-usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,337 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 May 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Primary school children of grades 5-8 (mostly aged between 8-12 years)
- Teachers and school leaders of participating schools (no age limit)
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Classroom-based Intervention Promoting Proscial Classroom Climate in Children
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).
Read the detailed description
A positive, prosocial classroom climate is associated with improved social competence and academic achievement, as well as decreased internalizing and externalizing problems and antisocial behavior in children. It is expected that motivation to behave prosocially is needed to achieve a prosocial climate in the classroom, and that such motivation can be enhanced through three components of self-determination theory (SDT): competence, relatedness, and autonomy. The goal of this study is to examine the effectiveness of a classroom-based program based on SDT that aims to promote prosocial classroom climate, through a cluster Randomized Controlled Trial (RCT). SterkWerk is hypothesized to be more effective than treatment-as-usual (TAU) in creating more prosocial classrooms, through improving prosocial (intrinsic) motivation and behavior, social autonomy, social competence, and social relatedness.
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 in the intervention condition receive the materials and training to implement the intervention in the school year 2023/2024. Schools in the control group do not receive the intervention (do not receive material or training), and function as normal (TAU). Control schools are requested to not start any social-emotional program during the school year 2023/2024.
- Conditions
- Child Behavior
- Being tested
- SterkWerk, Treatment-as-usual
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SterkWerkBehavioural
Classroom-based intervention program
Treatment-as-usualBehavioural
Also called TAU
Active control group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Treatment-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
This is a self-reported instrument. School belonging is measured with 7 items, rated on a 4-point scale ranging from 1 (never) to 4 (always). Higher scores reflect positive school wellbeing.
Measured: 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
This is a self-reported instrument. School safety is measured with 1 item, rated on a 7-point scale ranging from 1 (very unsafe) to 7 (very safe). Higher scores reflect positive school wellbeing.
Measured: 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
Children see a list with the names of all classmates and select the classmates that fit the question best according to them. Five items are used, assessing the child's social position according to classmates. The number of received nominations is devided by the number of possible nominations, resulting in a proportion score for each social position (kindness, leadership, unkindness, popularity, best friends).
Measured: 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)
The OB-VQ is a self-reported instrument, consisting of items related to bullying, bullying victimization and the perceived behavior and attitudes of the teacher. Nine items related to bullying and victimization are rated on a 5-point Likert scale ranging from 1 (I did not bully / I was not bullied) to 5 (several times a week). Higher scores reflect more bullying and victimization.
Measured: 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)
The OB-VQ is a self-reported instrument, consisting of items related to bullying, bullying victimization and the perceived behavior and attitudes of the teacher. One item asks where the child is bullied. with answer options such as: in the halway, on the way to school, in the classroom (with the teacher present).
Measured: 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)
The OB-VQ is a self-reported instrument, consisting of items related to bullying, bullying victimization and the perceived behavior and attitudes of the teacher. Three items relate to the perceived behavior and attitude of the teacher. Higher scores reflect more negative attitudes/behavior of the teacher.
Measured: 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 sociometric nominations
Regarding sociometric nominations,10 questions related to bullying victimization and one question related to bullying will be asked to children. Children see a list with the names of all classmates and select the classmates that fit the question best according to them. The number of received nominations is devided by the number of possible nominations, resulting in a proportion score for bullying.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start11 May 2023
- Primary completion31 Jul 2024
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 2,337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utrecht University
- Sponsor type
- University, hospital or other
- Collaborators
- KiVa B.V., Netherlands Organisation for Scientific Research
- Responsible party
- Principal investigator, Amanda van Loon, Utrecht University
- Investigators
- Tessa Kaufman, dr., Principal investigator, Utrecht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891067
- Sponsor's protocol ID
- UtrechtU
- Other IDs
- 23-0082
- Status last verified
- May 2026
- First submitted
- 28 Apr 2023
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during and/or analysed during the current study will be stored in a publicly available repository.
Publications
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.
PubMed 37501078van Loon, A., & Kaufman, T. (2025). Eindrapportage: De effectiviteit van SterkWerk in het basisonderwijs. Nationaal Kennisinstituut Onderwijs. https://www.nko.nl/sites/nro/files/media-files/eki_eindrapportage_sterkwerk.pdf
van Loon, A. ., & Kaufman, T. (2026). De Effectiviteit van een Schoolinterventie voor het Vergroten van een Prosociaal Klasklimaat voor Basisschoolkinderen. Jeugd in Ontwikkeling , 2. https://doi.org/10.54447/JiO.23463
Sun Y, van Loon AWG, Kaufman TML. Pathways to Prosociality: How Classroom Strategies That Support Basic Psychological Needs Foster Prosocial Behavior in Children. Prev Sci. 2026 Mar;27(3):451-463. doi: 10.1007/s11121-026-01895-2. Epub 2026 Mar 18.
PubMed 41851565
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Classroom-based Intervention Promoting Proscial Classroom Climate in Children
- ClinicalTrials.gov ID
- NCT05891067
- Acronym / sponsor ID
- UtrechtU
- Conditions
- Child Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,337 participants (actual)
- Lead sponsor
- Utrecht UniversityUniversity, hospital or other
- Collaborators
- KiVa B.V., Netherlands Organisation for Scientific Research
- Study start
- 11 May 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
A positive, prosocial classroom climate is associated with improved social competence and academic achievement, as well as decreased internalizing and externalizing problems and antisocial behavior in children. It is expected that motivation to behave prosocially is needed to achieve a prosocial climate in the classroom, and that such motivation can be enhanced through three components of self-determination theory (SDT): competence, relatedness, and autonomy. The goal of this study is to examine the effectiveness of a classroom-based program based on SDT that aims to promote prosocial classroom climate, through a cluster Randomized Controlled Trial (RCT). SterkWerk is hypothesized to be more effective than treatment-as-usual (TAU) in creating more prosocial classrooms, through improving prosocial (intrinsic) motivation and behavior, social autonomy, social competence, and social relatedness.
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 in the intervention condition receive the materials and training to implement the intervention in the school year 2023/2024. Schools in the control group do not receive the intervention (do not receive material or training), and function as normal (TAU). Control schools are requested to not start any social-emotional program during the school year 2023/2024.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SterkWerk | Experimental | Behavioral: SterkWerkSterkWerk 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. |
| Treatment-as-usual | Active comparator | Behavioral: Treatment-as-usualSchools 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Primary school children of grades 5-8 (mostly aged between 8-12 years)
- Teachers and school leaders of participating schools (no age limit)
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SterkWerkClassroom-based intervention program | Behavioural | SterkWerk |
| Treatment-as-usualAlso: TAUActive control group | Behavioural | Treatment-as-usual |
Primary outcome
Change in prosocial behavior as an injunctive form assessed with three items specifically developed for this study
Time frame: 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
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.
Change in individual prosocial behavior assessed with four items based on the subscale prosocial behavior of the Strengths and Difficulties Questionnaire
Time frame: 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
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.
Change in prosocial relations in the classroom assessed with sociometric nominations
Time frame: 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
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.
Change in cooperation and conflict in the classroom assessed with the Classroom Peer Context Questionnaire (CPCQ), subscales cooperation and conflict.
Time frame: 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
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.
Change in intrinsic (prosocial) motivation assessed with four items specifically developed for this study
Time frame: 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
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.
Change in social competence assessed with five items based on the Rosenberg Self-Esteem Scale (RSES)
Time frame: 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
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.
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
Time frame: 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
It is a self-reported instrument, rated on a 4-point scale ranging from 1 (never) to 4 (always). Higher scores reflect more autonomy.
Change in social relatedness assessed with the Classroom Peer Context Questionnaire (CPCQ), subscales comfort and cohesion.
Time frame: 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
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.
7 secondary outcomes
Change in school wellbeing assessed with seven items specifically developed for this study
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 sociometric nominations
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Results publication: PubMed 37501078van 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.
- Results publicationvan Loon, A., & Kaufman, T. (2025). Eindrapportage: De effectiviteit van SterkWerk in het basisonderwijs. Nationaal Kennisinstituut Onderwijs. https://www.nko.nl/sites/nro/files/media-files/eki_eindrapportage_sterkwerk.pdf
- Results publicationvan Loon, A. ., & Kaufman, T. (2026). De Effectiviteit van een Schoolinterventie voor het Vergroten van een Prosociaal Klasklimaat voor Basisschoolkinderen. Jeugd in Ontwikkeling , 2. https://doi.org/10.54447/JiO.23463
- Results publication: PubMed 41851565Sun Y, van Loon AWG, Kaufman TML. Pathways to Prosociality: How Classroom Strategies That Support Basic Psychological Needs Foster Prosocial Behavior in Children. Prev Sci. 2026 Mar;27(3):451-463. doi: 10.1007/s11121-026-01895-2. Epub 2026 Mar 18.
- Website of SterkWerk (Meaningful Roles)Link provided by the sponsor.
- Information on Utrecht University websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The datasets generated during and/or analysed during the current study will be stored in a publicly available repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tessa Kaufman, dr. principal investigator
Utrecht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SterkWerk and Treatment-as-usual in people with Child Behavior, run by Utrecht University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in prosocial behavior as an injunctive form assessed with three items specifically developed for this study (time frame: 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05891067, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.