NCT03745573

Brief Summary

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. A two arm cluster RCT with parallel assignment will be conducted.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,120

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

November 16, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

1.1 years

First QC Date

November 6, 2018

Last Update Submit

November 16, 2018

Conditions

Keywords

corporal punishment, teacher violence, school violence, sexual violence

Outcome Measures

Primary Outcomes (1)

  • physical violence

    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 Outcomes (4)

  • physical violence

    Assessed at 6-month follow-up

  • emotional violence

    past 1 week; assessed at 10-week and 6-month follow-up

  • depressive symptoms

    past 2 weeks; assessed at 10-week and 6-month follow-up

  • educational performance

    assessed at the end of the school year, about 11-12 months from baseline

Study Arms (2)

Empateach Intervention

EXPERIMENTAL

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.

Behavioral: Empateach

Wait-list control

NO INTERVENTION

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).

Interventions

EmpateachBEHAVIORAL

Empateach is a behavioural intervention for teachers.

Empateach Intervention

Eligibility Criteria

Age9 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Bakari M, Shayo EH, Barongo V, Kiwale Z, Fabbri C, Turner E, Eldred E, Mubyazi GM, Rodrigues K, Devries K. Qualitative process evaluation of the EmpaTeach intervention to reduce teacher violence in schools in Nyarugusu Refugee Camp, Tanzania. BMJ Open. 2023 Sep 21;13(9):e069993. doi: 10.1136/bmjopen-2022-069993.

  • 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 Officials

  • Karen M Devries, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Henley, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the behavioural nature of the intervention, it is not possible to mask allocation to participants. Outcome assessors will not be told of allocation, but due to the nature of the intervention they should be assumed to be unmasked. The statistician performing the main trial analyses related to primary and secondary outcomes will be masked to allocation, but other investigators will not.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Schools will be randomised to receive the intervention or a wait-list control condition. Assignment will be parallel.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2018

First Posted

November 19, 2018

Study Start

November 16, 2018

Primary Completion

December 31, 2019

Study Completion

July 31, 2020

Last Updated

November 19, 2018

Record last verified: 2018-11