ViolencePreVioNCT06369025
Preventing Physical and Emotional Violence by Parents and Teachers in Public Schools in Tanzania (ICC-T/ICC-P_Tanz)
A study testing Interaction Competencies with Children in people with Violence, run by Bielefeld University at 1 site in Tanzania.
Trial summary
More than 1.7 billion children worldwide experience violence in their upbringing. Prevalence rates are particularly high in Africa. Toxic stress associated with violence impacts the developing brain. This affects behavioral, social, and emotional functioning of children. Read more about this study
- Who is it for?
- Ages 9 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Violence
- What is being tested?
- Interaction Competencies with Children
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,848 participants
- Where
- 1 siteTanzania
- Study dates
- 15 Apr 2024to 30 Jul 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 9 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Schools:
- Public primary schools
- at least 45 students in selected class/ stream
- least 25 but no more than 50 employed teacher in selected school.
- All participants:
- Written informed consent (if underaged by parents (written) \& minors themselves (orally)
Show all 16Show fewer
- Students:
- Enrollment in selected public primary school, age between 9 and 13 years
- living with their caregiver or parents near to the schools
- Teachers:
- employed at the selected schools
- aged between 18 and 60 years of age (statutory retirement age)
- Parents:
- their child is participating in the study and is enrolled in a study's eligible school,
- social parent (the parent currently taking care of the child independent of the biological relationship to the children; social parents can be biological parents, step-parents, foster parents, relatives, etc.)
- aged between 16 and 80 years of age
Who cannot join
- Acute drug or alcohol intoxication,
- acute psychotic disorder
- severe mental disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Children's Mental Health by Preventing Teacher and Family Violence: A Pilot Cluster-randomized Controlled Trial
More than 1.7 billion children worldwide experience violence in their upbringing. Prevalence rates are particularly high in Africa. Toxic stress associated with violence impacts the developing brain. This affects behavioral, social, and emotional functioning of children. The present project will test an intervention that simultaneously aims at reducing violence against children at home and at school. Within the project, (1) the feasibility, acceptability, and cost-effectiveness of the Intervention and (2) the initial effectiveness of reducing parental and teacher violence will be tested. To this end, a mixed-methods two-arm school-based pilot cluster-randomized controlled trial (CRCT) in Tanzania will be conducted.
One unique and novel aspect of this project is to test a school-based intervention approach that targets both teachers and parents. A school-based approach including both teachers and parents has the following key advantages: (1) parents of different social, economic, and educational backgrounds can be motivated to participate and (2) using the existing infrastructure of schools reduces costs and will later improve the scalability of the program. The project is bringing together the global health, development economy, and psychological perspectives to promote our collaboration within the German global health community and with research and policy partners in Tanzania.
Read the detailed description
The study is a two-arm cluster-randomized controlled trial with 16 primary schools (clusters) in the Urban District of Morogoro in Eastern Tanzania as level of randomization. The eligible schools are located in 20 wards (smallest administrative unit). To avoid cross-over effects between the study conditions, only one school per ward will be selected. To select the final sample of schools, 16 out of the 20 wards schools will be randomly selected and then one school from each ward. Then pairs of schools will be randomly formed. These has primarily logistical reasons: Due to the short project period (12 months), the implementation of the intervention will start after completion of the baseline assessment in the first pair of schools and after randomly allocation of the first school to the intervention condition. The selection and allocation of the schools will be performed by an independent researcher neither belonging to the core research team nor involved in data collection process.
At each school, 45 students in the in 5th school grade, 90 parents (45 mothers \& 45 fathers = 90 parents) and 25 teacher will be recruited. Thus the final sample will comprise 720 students, 720 parent pairs (720 mothers \& 720 fathers) and 400 teachers at baseline across 16 schools.
The study will have two data assessment points: baseline assessment prior to the intervention, the one follow-up assessment three months after the intervention. In addition, feasibility data will be assessed in the intervention group at the beginning and the end of the intervention. The cluster-randomized control trails will additionally be accompanied by a process evaluation.Qualitative information will be collected after intervention training of parents and teachers to complement the quantitative data.
Primary outcome measures are student-, parents- and teacher-reported physical and emotional violence by the parents or teachers in the past week. Secondary outcome measures include adult-child relationship, children's emotional and behavioral problems, quality of life, parents' and teachers' stress level and school climate.
- Conditions
- Violence
- Being tested
- Interaction Competencies with Children
- Keywords
- school violence, teacher violence, parental violence, family violence, children, public schools, primary schools
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interaction Competencies with ChildrenBehavioural
Interaction Competencies with Children - for Teachers (ICC-T) Core training components include teacher-student interaction, maltreatment prevention, effective discipline strategies, identifying and supporting burdened students and implementation of the training materials into the school setting.
Interaction Competencies with Children - for Parents (ICC-P) Core training components include parents-child interaction, maltreatment prevention, effective discipline strategies, identifying and supporting burdened students and implementation of the training materials into the home
| Study group | Role | What they receive |
|---|---|---|
| ICC-T & ICC-P | Experimental | ICC-T: 5 days with 8 hours of training for teachers. Core training components include teacher-student interaction, maltreatment prevention, effective discipline strategies, identifying and supporting burdened students and implementation of the training materials into the school setting.
ICC-P: 4 days with 8 hours of training for parents. Core training components include parents-student interaction, maltreatment prevention, effective discipline strategies, identifying and supporting burdened children and implementation of the training materials into the daily home setting Receives: Behavioral: Interaction Competencies with Children |
| Monitoring condition | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of children's exposure to emotional and physical violence by parents and teachers
The Conflict Tactics Scale (CTS) will be used to assess children's self-reported experiences of emotional and physical violence by parents at home and teachers at school in the past week. Higher scores indicate higher levels of violence that is used by parents or teachers. A stronger reduction of exposure to violence in the children of parents and teachers of the intervention group compared to the control group is hypothesized.
Measured: The CTS will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
Reduction of parents' or teachers' use of emotional and physical violence
The Conflict Tactics Scale (CTS) will be used to assess parents' and teachers' use of emotional and physical violent discipline measures against children in the past week. Higher scores indicate higher levels of violence that is used by parents or teachers. A stronger reduction of violence use by parents and teachers of the intervention group compared to the control group is hypothesized.
Measured: The CTS will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
Secondary outcomes (4)
Change of parents' and teachers' attitudes towards emotional and physical violence
Teachers' and parents' attitudes towards emotional and physical violence will be assessed with an adapted version of the Conflict Tactic Scale (CTS). Higher scores indicate higher levels of positive attitudes towards violence. A stronger reduction of favourable attitudes towards violence of parents and teachers of the intervention group compared to the control group is hypothesized.
Measured: The adapted version of CTS will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
Improvement of children's mental health
The Pediatric Symptom Checklist - Youth Report (PSC-Y) will assess children's emotional and behavioral problems reported by children and parents. Higher scores indicate higher levels of children's mental health problems. A stronger improvement of mental health problems in the children of parents and teachers of the intervention group compared to the control group is hypothesized.
Measured: The PSC-Y will be used at T1 (baseline, prior to intervention) and T2 (first follow-up, 3 months after intervention)
Increase of children's quality of life
The KIDSCREEN-10 will assess children's quality of life reported by children and parents. Higher scores indicate higher levels of children's quality of life. A stronger increase of quality of life in the children of parents and teachers of the intervention group compared to the control group is hypothesized.
Measured: The KIDSCREEN-10 will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
Improvement of school climate
The Teacher Relationship with Colleagues will assess school climate reported by teachers. Higher scores indicate higher quality of school climate. A stronger increase of school climate quality in the intervention group compared to the control group is hypothesized.
Measured: The Teacher Relationship with Colleagues will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start15 Apr 2024
- Primary completion28 Feb 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ViolenceStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,848 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bielefeld University
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich, Dar es Salaam University College of Edcuation, Muhimbili University of Health and Allied Sciences
- Responsible party
- Principal investigator, Tobias Hecker, PhD, Bielefeld University
- Investigators
- Tobias Hecker, Prof. Dr., Principal investigator, Bielefeld University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369025
- Sponsor's protocol ID
- PreVio
- Acronym
- PreVio
- Status last verified
- Sep 2025
- First submitted
- 12 Apr 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The ICC-T intervention is being tested in various other countries including Haiti, Ghana, Tanzania and Uganda. ICC-P is being pilot tested in Tanzania. We will share anonymized data with project partners from the different countries for combined and/or comparative analyses. In addition, we will share anonymized data with other researchers working on prevention of violence against children in school settings for the purpose of conducting synthesizing analyses such as meta-analyses. Finally, the anonymized data collected in the study will be made publicly available in a data repository.
Publications
Mattonet K, Kabelege E, Mkinga G, Kolwey L, Nkuba M, Masath FB, Hermenau K, Schupp C, Steinert JI, Hecker T. School-based prevention of teacher and parental violence against children: Study protocol of a cluster-randomized controlled trial in Tanzania. BMC Public Health. 2024 Aug 31;24(1):2367. doi: 10.1186/s12889-024-19888-7.
PubMed 39217292
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Children's Mental Health by Preventing Teacher and Family Violence: A Pilot Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06369025
- Acronym / sponsor ID
- PreVio / PreVio
- Conditions
- Violence
- Keywords
- school violence, teacher violence, parental violence, family violence, children, public schools, primary schools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,848 participants (actual)
- Lead sponsor
- Bielefeld UniversityUniversity, hospital or other
- Collaborators
- Technical University of Munich, Dar es Salaam University College of Edcuation, Muhimbili University of Health and Allied Sciences
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 16 Apr 2024 (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.
More than 1.7 billion children worldwide experience violence in their upbringing. Prevalence rates are particularly high in Africa. Toxic stress associated with violence impacts the developing brain. This affects behavioral, social, and emotional functioning of children. The present project will test an intervention that simultaneously aims at reducing violence against children at home and at school. Within the project, (1) the feasibility, acceptability, and cost-effectiveness of the Intervention and (2) the initial effectiveness of reducing parental and teacher violence will be tested. To this end, a mixed-methods two-arm school-based pilot cluster-randomized controlled trial (CRCT) in Tanzania will be conducted.
One unique and novel aspect of this project is to test a school-based intervention approach that targets both teachers and parents. A school-based approach including both teachers and parents has the following key advantages: (1) parents of different social, economic, and educational backgrounds can be motivated to participate and (2) using the existing infrastructure of schools reduces costs and will later improve the scalability of the program. The project is bringing together the global health, development economy, and psychological perspectives to promote our collaboration within the German global health community and with research and policy partners in Tanzania.
Detailed description
The study is a two-arm cluster-randomized controlled trial with 16 primary schools (clusters) in the Urban District of Morogoro in Eastern Tanzania as level of randomization. The eligible schools are located in 20 wards (smallest administrative unit). To avoid cross-over effects between the study conditions, only one school per ward will be selected. To select the final sample of schools, 16 out of the 20 wards schools will be randomly selected and then one school from each ward. Then pairs of schools will be randomly formed. These has primarily logistical reasons: Due to the short project period (12 months), the implementation of the intervention will start after completion of the baseline assessment in the first pair of schools and after randomly allocation of the first school to the intervention condition. The selection and allocation of the schools will be performed by an independent researcher neither belonging to the core research team nor involved in data collection process.
At each school, 45 students in the in 5th school grade, 90 parents (45 mothers \& 45 fathers = 90 parents) and 25 teacher will be recruited. Thus the final sample will comprise 720 students, 720 parent pairs (720 mothers \& 720 fathers) and 400 teachers at baseline across 16 schools.
The study will have two data assessment points: baseline assessment prior to the intervention, the one follow-up assessment three months after the intervention. In addition, feasibility data will be assessed in the intervention group at the beginning and the end of the intervention. The cluster-randomized control trails will additionally be accompanied by a process evaluation.Qualitative information will be collected after intervention training of parents and teachers to complement the quantitative data.
Primary outcome measures are student-, parents- and teacher-reported physical and emotional violence by the parents or teachers in the past week. Secondary outcome measures include adult-child relationship, children's emotional and behavioral problems, quality of life, parents' and teachers' stress level and school climate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICC-T & ICC-P | Experimental | Behavioral: Interaction Competencies with ChildrenICC-T: 5 days with 8 hours of training for teachers. Core training components include teacher-student interaction, maltreatment prevention, effective discipline strategies, identifying and supporting burdened students and implementation of the training materials into the school setting. ICC-P: 4 days with 8 hours of training for parents. Core training components include parents-student interaction, maltreatment prevention, effective discipline strategies, identifying and supporting burdened children and implementation of the training materials into the daily home setting |
| Monitoring condition | No intervention | –No intervention |
Who may qualify
- Ages
- 9 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Public primary schools
- at least 45 students in selected class/ stream
- least 25 but no more than 50 employed teacher in selected school.
- Written informed consent (if underaged by parents (written) \& minors themselves (orally)
- Enrollment in selected public primary school, age between 9 and 13 years
Key exclusion criteria (3 listed)
- Acute drug or alcohol intoxication,
- acute psychotic disorder
- severe mental disabilities
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 |
|---|---|---|
| Interaction Competencies with ChildrenInteraction Competencies with Children - for Teachers (ICC-T) Core training components include teacher-student interaction, maltreatment prevention, effective discipline strategies, identifying and supporting burdened students and implementation of the training materials into the school setting. Interaction Competencies with Children - for Parents (ICC-P) Core training components include parents-child interaction, maltreatment prevention, effective discipline strategies, identifying and supporting burdened students and implementation of the training materials into the home | Behavioural | ICC-T & ICC-P |
Primary outcome
Reduction of children's exposure to emotional and physical violence by parents and teachers
Time frame: The CTS will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
The Conflict Tactics Scale (CTS) will be used to assess children's self-reported experiences of emotional and physical violence by parents at home and teachers at school in the past week. Higher scores indicate higher levels of violence that is used by parents or teachers. A stronger reduction of exposure to violence in the children of parents and teachers of the intervention group compared to the control group is hypothesized.
Reduction of parents' or teachers' use of emotional and physical violence
Time frame: The CTS will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
The Conflict Tactics Scale (CTS) will be used to assess parents' and teachers' use of emotional and physical violent discipline measures against children in the past week. Higher scores indicate higher levels of violence that is used by parents or teachers. A stronger reduction of violence use by parents and teachers of the intervention group compared to the control group is hypothesized.
4 secondary outcomes
Change of parents' and teachers' attitudes towards emotional and physical violence
Time frame: The adapted version of CTS will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
Improvement of children's mental health
Time frame: The PSC-Y will be used at T1 (baseline, prior to intervention) and T2 (first follow-up, 3 months after intervention)
Increase of children's quality of life
Time frame: The KIDSCREEN-10 will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
Improvement of school climate
Time frame: The Teacher Relationship with Colleagues will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after 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 19 Sep 2025.
- Derived from this study: PubMed 39217292Mattonet K, Kabelege E, Mkinga G, Kolwey L, Nkuba M, Masath FB, Hermenau K, Schupp C, Steinert JI, Hecker T. School-based prevention of teacher and parental violence against children: Study protocol of a cluster-randomized controlled trial in Tanzania. BMC Public Health. 2024 Aug 31;24(1):2367. doi: 10.1186/s12889-024-19888-7.
- Individual participant dataSharing planned: Yes. The ICC-T intervention is being tested in various other countries including Haiti, Ghana, Tanzania and Uganda. ICC-P is being pilot tested in Tanzania. We will share anonymized data with project partners from the different countries for combined and/or comparative analyses. In addition, we will share anonymized data with other researchers working on prevention of violence against children in school settings for the purpose of conducting synthesizing analyses such as meta-analyses. Finally, the anonymized data collected in the study will be made publicly available in a data 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.
Tobias Hecker, Prof. Dr. principal investigator
Bielefeld 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 Interaction Competencies with Children in people with Violence, run by Bielefeld University at 1 site in Tanzania.
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 16 inclusion and 3 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 19 Sep 2025. 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 Tanzania. 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?
Reduction of children's exposure to emotional and physical violence by parents and teachers (time frame: The CTS will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)). The study lists 2 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 NCT06369025, which also lists 1 linked publication.
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 19 Sep 2025.