Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT06369025
Study type Interventional
Source Bielefeld University
Contact Tobias Hecker, Prof. Dr.
Phone 00495211063105
Email tobias.hecker@uni-bielefeld.de
Status Recruiting
Phase N/A
Start date April 15, 2024
Completion date July 30, 2025

See also
  Status Clinical Trial Phase
Completed NCT00729391 - Women-Focused HIV Prevention in the Western Cape Phase 2/Phase 3
Recruiting NCT06062732 - Face It Evaluation N/A
Withdrawn NCT03762356 - Questionnaire About Individual's Insight/Awareness of Risk of Violence
Completed NCT02506088 - Preventing Sexual Aggression Among High School Boys N/A
Completed NCT02458365 - A Stage-Based Expert System for Teen Dating Violence Prevention Phase 2
Completed NCT00527358 - Evaluation of SAFER Latinos' Program to Prevent Youth Violence Phase 2/Phase 3
Completed NCT00251212 - Tailored Teen Alcohol and Violence Prevention in the Emergency Room (ER) N/A
Completed NCT00164541 - An Arts-Based Initiative for the Prevention of Violence Against Women and Girls Phase 1
Completed NCT01025674 - Randomized Trial of the Positive Action Program in Chicago Schools and Extension to Grade 8 N/A
Recruiting NCT05706376 - An Evidence-based Family Support Program for Parents and Children in Palestine: A Theory-based Intervention N/A
Recruiting NCT06001554 - Preventing Physical and Emotional Violence by Teachers in Public Schools in Pakistan N/A
Recruiting NCT05585918 - The R-CITY Project: A Collaborative Intervention With Teachers and Youth N/A
Recruiting NCT06099262 - GenPMTO Evaluation
Recruiting NCT05595759 - Violence Against Women in Patients With Alcohol Substance Addiction Training N/A
Completed NCT05207319 - Effects of Integrated Moral Reasoning Development Intervention for Management of Violence in Schizophrenia N/A
Completed NCT03473067 - Community Level Primary Prevention of Dating and Sexual Violence in Middle Schools N/A
Completed NCT06056661 - Within My Reach (WMR) Adaptation N/A
Not yet recruiting NCT04520399 - Prediction of Violent Behavior in Patients With Schizophrenia by Multimodal Machine Learning
Not yet recruiting NCT02257944 - Assessing and Reducing Risk of Violent Re-Injury Among Victims of Urban Violence N/A
Completed NCT01770873 - A Multi-Center Randomized Controlled Trial of Mentoring to Prevent Youth Violence N/A