Clinical trial NCT06369025: Preventing Physical and Emotional Violence by Parents and Teachers in Public Schools in Tanzania (ICC-T/ICC-P_Tanz)
Official title: Improving Children's Mental Health by Preventing Teacher and Family Violence: A Pilot Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Violence
Keywords: school violence
teacher violence
parental violence
family violence
children
public schools
primary schools
Lead sponsor: Bielefeld University
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
name: Dar es Salaam University College of Edcuation
name: Muhimbili University of Health and Allied Sciences
First posted: 2024-04-16
Enrollment: 1840
Sex: ALL
Minimum age (years): 9
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: General:

Inclusion Criteria:

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)

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

Exclusion criteria (all participants):

* Acute drug or alcohol intoxication,
* acute psychotic disorder
* severe mental disabilities

Primary outcomes:
measure: Reduction of children's exposure to emotional and physical violence by parents and teachers
timeFrame: The CTS will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
measure: Reduction of parents' or teachers' use of emotional and physical violence
timeFrame: The CTS will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
Secondary outcomes:
measure: Change of parents' and teachers' attitudes towards emotional and physical violence
timeFrame: The adapted version of CTS will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
measure: Improvement of children's mental health
timeFrame: The PSC-Y will be used at T1 (baseline, prior to intervention) and T2 (first follow-up, 3 months after intervention)
measure: Increase of children's quality of life
timeFrame: The KIDSCREEN-10 will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
measure: Improvement of school climate
timeFrame: The Teacher Relationship with Colleagues will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
Other outcomes:
measure: Reduction of children's perceived stress
timeFrame: The Stress Scale for Kids will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
measure: Reduction of parents' and teachers' perceived stress
timeFrame: The Parental Stress Scale and the Teachers Stress Inventory will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
measure: Improvement of teachers' decision making
timeFrame: Teacher Participation in Decision Making will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
measure: Improvement of teachers' self-efficacy
timeFrame: Teachers Sense of Efficacy Scale will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
Locations:
city: Daressalam
country: Tanzania
facility: Daressalaam University College of Education
Study officials:
affiliation: Bielefeld University
name: Tobias Hecker, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: