- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06554418
What Works to Prevent Violence Against Women and Girls in Somalia
What Works to Prevent Violence Against Women and Girls: Evaluation of the Communities Care Program in Somalia
The Communities Care (CC) program has demonstrated promise in changing harmful social norms associated with Gender-based violence (GBV) and increasing confidence in services for women and girls. Therefore, the study will adapt the existing CC program based on previous learnings with adults and expand programming to include adolescent boys and girls, creating the CC adult and CC adolescent program. The CC program intervention implementation will be led by Comitato Internazionale per lo Sviluppo dei Popoli (CISP) non-Governmental Organization (NGO) in partnership with Somalia Ministry of Education and local Women led Organizations (WLO), public schools and mapped GBV and child protection (CP) service providers in Banadir and Galmudug regions of Somalia.
Johns Hopkins will collaborate with local research colleagues to evaluate the CC adult and CC adolescent program. The study will use a hybrid type 2 effectiveness-implementation design guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Quantitative methods will be used to measure outcomes at baseline and endline (24 months post baseline) with adults and adolescents (10 and older) participants in the CC programs in intervention compared to control districts in the two regions (Banadir and Galmudug) in South Central Somalia. Quantitative methods will also be used to measure outcomes with adults and adolescents (10 years and older) community members (members that do not participate in the CC program) in intervention and control districts in the 2 regions at baseline, midline (12-months), endline (24-months) and maintenance (36 months). In addition, quantitative and qualitative methods at midline and endline will be used to measure the CC adult and CC adolescent intervention reach, adoption, implementation and maintenance in intervention districts in the two regions.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nancy Glass, PhD
- Phone Number: 4432579947
- Email: nglass1@jhu.edu
Study Locations
-
-
Wadajir District
-
Mogadishu, Wadajir District, Somalia
- Recruiting
- CISP Somalia
-
Contact:
- Michele Stella
- Email: michele.stella@cisp-ngo.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Age 10 years or older
- Participant in CC adult or CC adolescent program in collaboration with 9 public schools in districts randomized to intervention or control in two regions of Somalia
- Living/resident of target districts (including internally displaced persons (IDPs) and does not have plans to move/leave the district or surrounding area in the next 12 months (this is critical for the longitudinal data collection with CC program participants)
Exclusion Criteria:
- Less than 10 years old
- Not a participant in CC adult or CC adolescent
- Not a resident of target districts-
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: Communities Care
Districts in two regions of Somalia randomized to Communities Care violence prevention program with adults and adolescents
|
Communities Care is a violence prevention program targeting social norms and behavioral change
|
|
No Intervention: Control
Districts in two regions of Somalia randomized to control - usual programming related to prevention of violence
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cyber-Sexual Harassment survey score
Time Frame: 9 and 12 months
|
Adolescent report of experience of peer-to-peer or adult on-line and in-person harassment, Mean scale score ranges from 1 to 5 with higher scores being worse outcome
|
9 and 12 months
|
|
Peer-to-peer physical and sexual violence in school and community survey score
Time Frame: 9 and 12 months
|
Adolescent report of experience of peer to peer violence in schools, Mean scale score ranges from 1 to 5 with higher scores being worse outcome
|
9 and 12 months
|
|
Harsh punishment in school as assessed by the Parent-Child Conflict Scale adapted for teachers
Time Frame: 9 and 12 months
|
Adolescent report of witness or experience harsh punishment in school using the Parent-Child Conflict Tactics Scale adapted for teachers, Mean scale score 1-5, with higher score being worse outcome
|
9 and 12 months
|
|
Witnessing intimate partner violence (IPV) survey score
Time Frame: 9 and 12 months
|
Adolescent report of witnessing IPV in the household, mean scale score ranges from 1 to 5 with higher scores being worse outcome
|
9 and 12 months
|
|
Harsh Punishment in Household as assessed by the Parent-Child Conflict Scale
Time Frame: 9 and 12 months
|
Adolescent report of witness and experience harsh punishment in household using Parent-Child Conflict Tactics Scale, mean scale score ranges from 1 to 5 with higher scores being worse outcome
|
9 and 12 months
|
|
IPV victimization and/or perpetration as assessed by Somalia National Survey
Time Frame: 9 and 12 months
|
Adult report of experience and/or perpetration of IPV, mean scale score ranges from 1 to 5 with higher scores being worse outcome
|
9 and 12 months
|
|
Use of Harsh Punishment in Household as assessed by the Parent-Child Conflict Tactics Scale
Time Frame: 9 and 12 months
|
Adult report of use of harsh punishment, mean scale score ranges from 1 to 5 with higher scores being worse outcome
|
9 and 12 months
|
|
Non-partner harassment as assessed by the National Somalia Survey
Time Frame: 9 and 12 months
|
Adult report of non-partner harassment, mean scale score ranges from 1 to 5 with higher scores being worse outcome
|
9 and 12 months
|
|
Non-partner physical and/or sexual violence victimization as assessed by the National Somalia Survey
Time Frame: 9 and 12 months
|
Adult report of physical and/or sexual violence victimization by non-partner, mean scale score ranges from 1 to 5 with higher scores being worse outcome
|
9 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Personal Beliefs and Social Norms about Gender Based Violence as assessed by the Social Norms and Beliefs about Gender Based Violence Scale
Time Frame: 9 and 12 months
|
Adolescent and adult personal beliefs and social norms about gender based violence, mean scale scores range from 1-5, higher scores being worse outcome
|
9 and 12 months
|
|
Gender equality survey score
Time Frame: 9 and 12 months
|
Adult and adolescent report of equality in access to education, resources and decision making between women/girls and men/boys, mean scale score range from 1-5, higher score is worse outcome
|
9 and 12 months
|
|
IPV acceptability survey score
Time Frame: 9 and 12 months
|
Adult and adolescent report on acceptability of intimate partner violence (IPV), for example, It is justifiable for a husband to hit his wife because she argues with him, it is acceptable for a husband to force his wife to have sex when she does not want to.
mean subscale score range from 1-5, higher score is worse outcome
|
9 and 12 months
|
|
Sexual and reproductive health knowledge and empowerment score
Time Frame: 9 and 12 months
|
Adolescent knowledge in the domains of puberty, female genital mutilation (FGM), child marriage, and sexually transmitted infection (STI) and empowerment measured for puberty, child marriage, FGM, PV, and contraception use, mean scale score range from 1-5, higher score is better outcomes
|
9 and 12 months
|
|
Confidence in service providers (adolescents and adults) score
Time Frame: 9 and 12 months
|
Adolescent and adult report on confidence in service providers in responding to gender based violence across several sectors (health care, justice system, elders, psychosocial services and community health workers).
Mean scale score range from 1-5, higher score is better outcome
|
9 and 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nancy Glass, PhD, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- IRB00418976
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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