Preventing Physical and Emotional Violence by Parents and Teachers in Public Schools in Tanzania (ICC-T/ICC-P_Tanz)

Violence Clinical Trial

— PreVio  

Official title:

Improving Children's Mental Health by Preventing Teacher and Family Violence: A Pilot Cluster-randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06369025
• Other study ID #: PreVio
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: July 30, 2025

Study information

• Verified date: April 2024
• Source: Bielefeld University
• Contact: Tobias Hecker, Prof. Dr.
• Phone: 00495211063105
• Email: tobias.hecker[@]uni-bielefeld.de
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1840
• Est. completion date: July 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Violence

Intervention

Behavioral:
• Interaction Competencies with Children
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

Locations

Country	Name	City	State
Tanzania	Daressalaam University College of Education	Daressalam

Sponsors (4)

Lead Sponsor	Collaborator
Bielefeld University	Dar es Salaam University College of Edcuation, Muhimbili University of Health and Allied Sciences, Technical University of Munich

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reduction of children's perceived stress	The Stress Scale for Kids will assess the perceived stress of children reported by children. Higher scores indicate higher levels of stress. A stronger decrease of children's perceived stress in the children of parents and teachers of the intervention group compared to the control group is hypothesized.	The Stress Scale for Kids will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
Other	Reduction of parents' and teachers' perceived stress	The Parental Stress Scale will assess the perceived stress of parents reported by parents. The Teachers Stress Inventory will assess the perceived stress of teachers reported by teachers. Higher scores indicate higher levels of stress. A stronger decrease of parents' and teachers' perceived stress in the intervention group compared to the control group is hypothesized.	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)
Other	Improvement of teachers' decision making	The Teacher Participation in Decision Making will assess the teachers' decision making strategies reported by teachers. Higher scores indicate better decision making strategies. A stronger increase indecision making strategies in the intervention group compared to the control group is hypothesized.	Teacher Participation in Decision Making will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
Other	Improvement of teachers' self-efficacy	The Teachers Sense of Efficacy Scale will assess the teachers' self-efficacy reported by teachers. Higher scores indicate higher levels of self-efficacy. A stronger increase of self-efficacy in the intervention group compared to the control group is hypothesized.	Teachers Sense of Efficacy Scale will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
Primary	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.	The CTS will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
Primary	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.	The CTS will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
Secondary	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.	The adapted version of CTS will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
Secondary	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.	The PSC-Y will be used at T1 (baseline, prior to intervention) and T2 (first follow-up, 3 months after intervention)
Secondary	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.	The KIDSCREEN-10 will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)
Secondary	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.	The Teacher Relationship with Colleagues will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention)