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, University of Rwanda (UR), Research Ethical Review Board (jbgahutu@yahoo.com; PO Box 4285, Kigali, Rwanda; +252574302)
2. Approved 18/06/2018, Institut Superieur du Lac (ISL), Research Ethical Commission (islsantementale@gmail.com; PO Box 20, Goma, Democratic Republic of Congo)
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 1 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
United Kingdom
+44 (0)203 763 0510
r.vokes@elrha.org
Sponsor type
Charity
Website
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 North Kivu and South 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
- ISRCTN14765686_PIS_20Aug19.docx Uploaded 10/01/2020