Condition category
Not Applicable
Date applied
18/07/2019
Date assigned
06/01/2020
Last edited
10/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
During the last two decades, the Democratic Republic of Congo (DRC) has been plagued by wars and violent conflicts whereby Sexual Gender-Based Violence (SGBV) constituted a major problem, particularly in the eastern part of the country. In the North and South Kivu, rape and sexual violence were used as a weapon of war. This study aims to provide empirical evidence about the psychological and social impact of the improved public health intervention in the reduction of SGBV, particularly the intervention that promotes positive masculinity. The study is restricted to the psychological and social impact on the Living Peace Intervention (LPint), which is a group therapeutic method implemented by Living Peace Institute aimed to promote positive masculinity by working with men perceived as violent by their communities in the North and South Kivu of the Democratic Republic of Congo (DRC). To this end, the primary aim is to measure the psychological and social impact of LPint by looking at GBV reduction and its consequences for the targeted men, their wives/partners, their children and their communities. The secondary aim assesses whether this change in behavior (i.e. reduced GBV) is mediated or moderated by a reduction in symptoms of Post-Traumatic Stress Disorder (PTSD) or other psychopathological conditions.

Who can participate?
Participants in the study include adult male and female (above 18 years of age) who will have expressed their ability to understand the study purpose and consent to take part in the study. They include male beneficiaries of Living Peace intervention (LPint), as well as male and female who have not benefited from Lpint. Approximately 800 male and 800 female will participate.

What does the study involve?
The Living Peace intervention in Eastern DRC, through a group therapeutic method, works with men who are perceived as violent by their communities. Through a 16-­session, 16-week group therapeutic intervention. Selected participants sit together in groups of 15 men, the men work around the concept of Positive Masculinity to reduce Gender-Based Violence (GBV). Through promoting positive masculinity, men are assisted to develop alternative coping strategies to violence that are gender transformative and constructive in dealing with problems. Men are guided to internalize new norms on masculinities and gender relations that highlight men’s capacity and responsibility in promoting security and peace.

What are the possible benefits and risks of participating?
This study will help to understand the relationship between conflict and SGBV from the perpetrator perspective in relation to mental health, as well as how an intervention can reduce this problem. The study will enable to understand whether a change in men’s SGBV due to Living Peace intervention (LPint) is moderated or mediated by a reduction in symptoms of mental health conditions (i.e., PTSD, Depression, Alcohol abuse). Therefore, the study’s results are expected to be exploited (used) in the longer term to improve health results through more cost-effective public health interventions in humanitarian crises. Anticipated risks of participating include private or sensitive information that may damage the social standing or reputation of participants.

Where is the study run from?
The study will be carried out in 30 villages affected by the conflict in the North and South Kivu of the DRC where Living Peace Institute (LPI) is operating. Stakeholders include various research institutions and operational humanitarian organizations, as well as individual research experts, locally and internationally. Four key partner institutions include (1) the Center for Mental Health (CMH) of the University of Rwanda, College of Medicine and Health Sciences; (2) the Center for Gender Studies (CGS), University of Rwanda; (3) the Living Peace Institute (LPI) located in Goma; (4) the Institut Supérieur du Lac (ISL) that gives university-level training in mental health, clinical psychology and counselling based in Goma, DRC; as well as (5) trauma individual specialists.

When is the study starting and how long is it expected to run for?
The study started in 2018 and is expected to run for 2 years

Who is funding the study?
The study is funded by a registered charity in England and Wales that finds solutions to complex humanitarian problems through research and innovation (ELRHA) which means Enhancing Learning & Research for Humanitarian Assistance.

Who is the main contact?
Stefan Jansen (sjansen.ur@gmail.com).

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stefan Jansen

ORCID ID

http://orcid.org/0000-0001-5293-1673

Contact details

KK 737 Street
Gikondo
Kigali
PO BOX 4285
Kigali
N/A
Rwanda
+250784575900
sjansen.ur@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

R2HC

Study information

Scientific title

Evaluating the Psychological and Social Impact by Promoting Positive Masculinity Through the ‘Living Peace’ intervention (LPint) in DRC

Acronym

LPiNT

Study hypothesis

1. Success of LPiNT implies GBV reduction
2. Success of LPiNT in GBV reduction is mediated by reduction of PSTD or other social pathological conditions

Ethics approval

1. Approved 15/04/2019, Univeristy of Rwand (UR), Research Ethical Review Board (jbgahutu@yahoo.com; Po. box: 4285 Kigali; +252574302)
2. Approved 18/06/2018, Institut Superieur du Lac (ISL), Research Ethical Commission (islsantementale@gmail.com; Po. Box 20 Goma)

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

See additional files

Condition

Sexual and gender-based violence

Intervention

This study will use a Cluster Randomized Controlled Trial (CRCT) with persons-level and cluster-level outcomes. The counterfactual is villages that are listed as being eligible for LPint, but where no group therapy sessions are happening. The unit of randomization is an LPint locality (LPint-L), mostly a village, where on average two or three LPint groups of 15 men can be formed. This design allows us to make comparisons between LPint-Ls so we can measure the impact of LPint on the level of communities. From a selected list of eligible LPint-Ls, we will randomly allocate half of the LPint-Ls to the treatment group and half to the control group. All eligible men in a LPint-L, for both treatment and control groups, are recruited in the study. Concerning the primary aim of measuring the psychological and social impact of LPint, this study will look at GBV reduction and its consequences for the targeted men, their wives/partners, their children and their communities. With regard to the secondary aim assessing whether change in behavior (i.e. reduced GBV) is mediated or moderated by a reduction in symptoms of post-traumatic stress disorder (PTSD) or other psychopathological conditions, the study will use standardized scales of PTSD and other psychopathological conditions to test whether they mediate or moderate the reduction of GBV. Finally, to contextualize empirical findings, we will use qualitative research, with individual and focus group interviews as methods, to understand cultural idioms of distress and cultural explanation models.

A rotary method using papers was used for randomisation of villages.

Through a 16-­session, 16-week group therapeutic intervention. Selected participants sit together in groups of 15 men, the men work around the concept of Positive Masculinity to reduce Gender-Based Violence (GBV). Through promoting positive masculinity, men are assisted to develop alternative coping strategies to violence that are gender transformative and constructive in dealing with problems. Men are guided to internalize new norms on masculinities and gender relations that highlight men’s capacity and responsibility in promoting security and peace. The group therapy sessions are led by the facilitators of the case/experimental group. This means that they are selected based on merit. They are trained to facilitate group therapy sessions by the LP Master trainers (who are mostly psychologists) based on the LP Intervention. These master trainers do a monthly clinical supervision to make sure the group therapy is going as planned.

Data will be collected in three rounds: baseline (before the group therapy session start), endline1 (immediately after the end of the group therapy sessions), and endline2 (1 full year after the end of the group therapy sessions). This will allow for a quantitative measure of the impact of LPint immediately after and 1 year after. In addition, at baseline, some participants will be randomly selected to participate in qualitative focus group discussions or individual in-depth interviews.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Collected at baseline, immediately post-therapy (16-weeks), and one-year post-therapy:
1. The impact on men is measured using a standardised questionnaire (IMAGES survey), interviews (individual and focus group) and fieldwork notes
2. The impact on families is measured using a standardised questionnaire (IMAGES survey), interviews (individual and focus group) and fieldwork notes
3. The impact on communities is measured using a standardised questionnaire (IMAGES survey), interviews (individual and focus group) and fieldwork notes

Secondary outcome measures

Collected at baseline, immediately post-therapy (16-weeks), and one-year post-therapy:
1. Symptoms of PTSD are measured using a standardised questionnaire (IMAGES survey), interviews (individual and focus group) and fieldwork notes
2. Symptoms of depression are measured using a standardised questionnaire (IMAGES survey), interviews (individual and focus group) and fieldwork notes
3. Symptoms of alcohol abuse are measured using a standardised questionnaire (IMAGES survey), interviews (individual and focus group) and fieldwork notes

Overall trial start date

01/06/2018

Overall trial end date

01/06/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Able to understand and give informed consent.

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

800

Participant exclusion criteria

Minors.

Recruitment start date

01/07/2018

Recruitment end date

31/07/2018

Locations

Countries of recruitment

Congo, Democratic Republic

Trial participating centre

Bandare
South Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Bwegera
South Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Katogota
South Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Lubarika
South Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Luvungi 1
South Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Luvungi 2
South Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Mirungu
South Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Ndolera
South Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Nyamutiri
South Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Quartier Kasha
South Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Quartier Mukukwe
South Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Quartier Panzi
South Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Quartier Karhale
South Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Quartier Lumumba
South Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Quartier Nyakavogo
South Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Bethel
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Bihambwe
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Bihito
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Bikenge
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Bishange
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Busumba
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Bweremana
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Himbi
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Kaduki
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Kahe
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Kalinga
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Kanzenze
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Kasake
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Kasumo
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Kasura
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Katale
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Katindo
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Katoyi/Munzenze
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Kausa
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Kibabi
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Kihimba
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Kirorilwe
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Kitshanga
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Kitshanga A
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Kitsule
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Luhonga
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Lushangi
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Lushebere
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Lushebere 2
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Matanda
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Matheusi
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Mishavu
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Mugunga
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Muheto
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Muhongozi
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Mumba
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Murambi
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Ngungu
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Nyakariba
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Rubangabanga
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Ruzirantaka
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Sake
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Shasha
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

St Benoit
North Kivu
N/A
Congo, Democratic Republic

Trial participating centre

Nyamitaba
North Kivu
N/A
Congo, Democratic Republic

Sponsor information

Organisation

ELRHA

Sponsor details

4th Floor
Phoenix House
8 Cathedral Rd
Cardiff CF11 9LJ
England
CF11 9LJ
United Kingdom
+44 (0)203 763 0510
r.vokes@elrha.org

Sponsor type

Charity

Website

https://www.elrha.org/

Funders

Funder type

Charity

Funder name

ELRHA

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Conducting capacity building workshop to assess and strengthen skills of research team members and potential research users
2. Publishing two peer-­‐reviewed primary research papers in open access format: one paper on the impact measured through RCT, and another paper on the mediating or moderating role of mental health conditions and its biologial correlates.
3. Attending two academic conferences to present the preliminary findings after analyzing the pre and post intervention data
4. Presentation of empirical findings at a hight level with governmental and intergovernmental agencies, aid organizations and funding bodies.

IPD sharing statement: the datasets generated during and/or analysed during the current study are/will be available upon request from Stefan Jansen (sjansen.ur@gmail.com). Quantitative data in spss format (i.e., from standardized and self-designed scales) and qualitative data (i.e., individual interview and focus group discussion data) will be available from Sept 2021 onward (1-year post finalization of the project). Stated research goals to be accepted by University of Rwanda ethical committee and data will be shared with Research institutions and NGOs. Datasets are permitted for secondary data analysis for research purposes. Consent from participants was obtained through the University of Rwanda and N-Kivu and S-Kivu regulatory bodies. The anonymisation code will be kept by the Principal Investigator and Main Statistician.

Intention to publish date

01/08/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/01/2020: The participant information sheet has been uploaded. 20/08/2019: Trial's existence confirmed by the University of Rwanda College of Medicine and Health Sciences Institutional Review Board.