- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03745573
Preventing Violence Against Children in Schools Study (PVACS)
Preventing Violence Against Children in Schools: Protocol for a Cluster Randomised Controlled Trial of the EmpaTeach Behavioural Intervention in Nyarugusu Refugee Camp
Study Overview
Status
Intervention / Treatment
Detailed Description
School is one of the most common settings where children may experience violence; and emerging evidence suggests that in some settings, school staff may be one of the most common perpetrator of violence against children.To date, no interventions to prevent violence in refugee camp schools have ever been rigorously evaluated. The primary objective of this project is to test the effectiveness of the Empateach intervention to prevent physical violence from teachers to students in Nyarugusu Refugee Camp, Tanzania. Secondary objectives are to assess the impact of the Empateach intervention on student's depressive symptoms, experience of emotional violence and educational test scores.
The aim of the Empateach intervention is to improve 'student and teacher well-being; self-regulation; teacher classroom management and teacher's use of positive discipline techniques'. Participants in the intervention condition will receive a 10-week group intervention.
A two arm cluster RCT will be conducted, with parallel assignment and an approximately 1:1 allocation ratio. Cross-sectional surveys of students will be conducted at three time points: a baseline, a midline immediately after the 10 week intervention; and an endline 6 months after then end of the intervention. The primary outcome, violence from school staff to students, will be measured using an adapted version of the ICAST-CI.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Patricia Henley, PhD
- Phone Number: 02079272221
- Email: patricia.henley@lshtm.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At the school level, all 27 primary and secondary schools in Nyarugusu refugee camp in Tanzania, will be eligible. The intervention is delivered to individual teachers, and all teachers working in included schools will be eligible to receive the intervention. The hypothesized intervention effect will be in all students being taught by participating teachers; however we will measure effects of the intervention in students who are aged 9 years and over. Data will be collected from both students and teachers.
- At the level of individual students, all students who can speak Kirundi or Swahili, and who are capable of providing assent, will be eligible to participate
- At the level of individual teachers, all teachers who can speak Kirundi or Swahili, and who are capable of providing informed consent, will be eligible to participate
Exclusion Criteria:
- there are no exclusion criteria at the School level
- for individual students, those who cannot speak Kirundi or Swahili, or who are not capable of providing assent
- for individual teachers, those who cannot speak Kirundi or Swahili, or who are not capable of providing informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Empateach Intervention
All teachers in intervention schools will be invited to participate.
Participants in the intervention condition will receive Empateach, a 10-week group intervention.
Groups meet 14 times for 1-1.5 hour length sessions, which are led by peers.
The aim of the Empateach intervention is to improve 'student and teacher well-being; self-regulation; teacher classroom management and teacher's use of positive discipline techniques.
The intervention uses cognitive behavioural therapy techniques to change negative thought and behaviour patterns related to corporal punishment.
The teachers receive information on alternatives to corporal punishment, planning exercises and reinforcement SMS, and because the intervention is in a group setting, social support to change their behaviours.
They discuss their experiences and challenges in group sessions.
|
Empateach is a behavioural intervention for teachers.
|
No Intervention: Wait-list control
Teachers in wait-list control schools will receive no specific interventions related to violence prevention during the study, but will receive the intervention after the study is over if it is shown to be effective (pending donor funding).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
physical violence
Time Frame: Assessed at 10-week follow-up
|
students' self-reports of physical violence from school staff in the past week, as measured by a modified ICAST-CI
|
Assessed at 10-week follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
physical violence
Time Frame: Assessed at 6-month follow-up
|
students' self-reports of physical violence from school staff in the past week, as measured by a modified ICAST-CI
|
Assessed at 6-month follow-up
|
emotional violence
Time Frame: past 1 week; assessed at 10-week and 6-month follow-up
|
students' self-reports of emotional violence from school staff, as measured by a modified ICAST-CI
|
past 1 week; assessed at 10-week and 6-month follow-up
|
depressive symptoms
Time Frame: past 2 weeks; assessed at 10-week and 6-month follow-up
|
students' self-reports of emotional violence from school staff, as measured by a modified ICAST-CI
|
past 2 weeks; assessed at 10-week and 6-month follow-up
|
educational performance
Time Frame: assessed at the end of the school year, about 11-12 months from baseline
|
test scores on yearly exams
|
assessed at the end of the school year, about 11-12 months from baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Karen M Devries, PhD, LSHTM
Publications and helpful links
General Publications
- Fabbri C, Rodrigues K, Leurent B, Allen E, Qiu M, Zuakulu M, Nombo D, Kaemingk M, De Filippo A, Torrats-Espinosa G, Shayo E, Barongo V, Greco G, Tol W, Devries KM. The EmpaTeach intervention for reducing physical violence from teachers to students in Nyarugusu Refugee Camp: A cluster-randomised controlled trial. PLoS Med. 2021 Oct 4;18(10):e1003808. doi: 10.1371/journal.pmed.1003808. eCollection 2021 Oct.
- Devries KM, Fabbri C, Allen E, Barongo V, Shayo E, Greco G, Kaemingk M, Qiu M, Steinacher R, Tol W, Rodrigues K. Preventing violence against children in schools (PVACS): protocol for a cluster randomised controlled trial of the EmpaTeach behavioural intervention in Nyarugusu refugee camp. BMC Public Health. 2019 Oct 15;19(1):1295. doi: 10.1186/s12889-019-7627-y.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 11106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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