Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369025
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-12
Brief Title:
Preventing Physical and Emotional Violence by Parents and Teachers in Public Schools in Tanzania ICC-TICC-P_Tanz
Sponsor:
Bielefeld University
Organization:
Bielefeld University
Study Overview
Official Title:
Improving Childrens Mental Health by Preventing Teacher and Family Violence A Pilot Cluster-randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PreVio
Brief Summary:
More than 17 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
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 evaluationQualitative 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 childrens emotional and behavioral problems quality of life parents and teachers stress level and school climate
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 evaluationQualitative 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 childrens emotional and behavioral problems quality of life parents and teachers stress level and school climate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None