Violence, PhysicalPVACSNCT03745573
Preventing Violence Against Children in Schools Study
A study testing Empateach in people with Violence, Physical and Violence, run by London School of Hygiene and Tropical Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Violence, Physical, Violence, Child Abuse
- What is being tested?
- Empateach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,120 participants
- Where
- No sites listed yet
- Study dates
- 16 Nov 2018to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Preventing Violence Against Children in Schools: Protocol for a Cluster Randomised Controlled Trial of the EmpaTeach Behavioural Intervention in Nyarugusu Refugee Camp
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.
Read the 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.
- Conditions
- Violence, Physical, Violence, Child Abuse, Violence Against Children
- Being tested
- Empateach
- Keywords
- corporal punishment, teacher violence, school violence, sexual violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpateachBehavioural
Empateach is a behavioural intervention for teachers.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical violence
students' self-reports of physical violence from school staff in the past week, as measured by a modified ICAST-CI
Measured: Assessed at 10-week follow-up
Secondary outcomes (4)
physical violence
students' self-reports of physical violence from school staff in the past week, as measured by a modified ICAST-CI
Measured: Assessed at 6-month follow-up
emotional violence
students' self-reports of emotional violence from school staff, as measured by a modified ICAST-CI
Measured: past 1 week; assessed at 10-week and 6-month follow-up
depressive symptoms
students' self-reports of emotional violence from school staff, as measured by a modified ICAST-CI
Measured: past 2 weeks; assessed at 10-week and 6-month follow-up
educational performance
test scores on yearly exams
Measured: assessed at the end of the school year, about 11-12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start16 Nov 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Violence, PhysicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Schools will be randomised to receive the intervention or a wait-list control condition. Assignment will be parallel.
- Masking
- None (open label)
- Enrolment
- 2,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Medical Research, Tanzania, Innovations for Poverty Action, Tanzania, International Rescue Committee, Behavioural Insights Team
- Responsible party
- Sponsor
- Investigators
- Karen M Devries, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745573
- Sponsor's protocol ID
- 11106
- Acronym
- PVACS
- Status last verified
- Nov 2018
- First submitted
- 6 Nov 2018
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will explore making anonymised data available after the end of the study, subject to UK and Tanzanian regulations.
Publications
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.
PubMed 37734883Fabbri 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.
PubMed 34606500Devries 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.
PubMed 31615467
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Violence Against Children in Schools: Protocol for a Cluster Randomised Controlled Trial of the EmpaTeach Behavioural Intervention in Nyarugusu Refugee Camp
- ClinicalTrials.gov ID
- NCT03745573
- Acronym / sponsor ID
- PVACS / 11106
- Conditions
- Violence, Physical, Violence, Child Abuse, Violence Against Children
- Keywords
- corporal punishment, teacher violence, school violence, sexual violence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,120 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Medical Research, Tanzania, Innovations for Poverty Action, Tanzania, International Rescue Committee, Behavioural Insights Team
- Study start
- 16 Nov 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Schools will be randomised to receive the intervention or a wait-list control condition. Assignment will be parallel.
| Arm | Type | Receives |
|---|---|---|
| Empateach Intervention | Experimental | Behavioral: EmpateachAll 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. |
| 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). |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpateachEmpateach is a behavioural intervention for teachers. | Behavioural | Empateach Intervention |
Primary outcome
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
4 secondary outcomes
physical violence
Time frame: Assessed at 6-month follow-up
emotional violence
Time frame: 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
educational performance
Time frame: assessed at the end of the school year, about 11-12 months from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Derived from this study: PubMed 37734883Bakari 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.
- Derived from this study: PubMed 34606500Fabbri 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.
- Derived from this study: PubMed 31615467Devries 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.
- Individual participant dataSharing planned: Undecided. We will explore making anonymised data available after the end of the study, subject to UK and Tanzanian regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen M Devries, PhD principal investigator
London School of Hygiene and Tropical Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Empateach in people with Violence, Physical and Violence, run by London School of Hygiene and Tropical Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Henley, PhD (02079272221, patricia.henley@lshtm.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical violence (time frame: Assessed at 10-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03745573, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.