NCT06554418

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,500

participants targeted

Target at P75+ for not_applicable

Timeline
42mo left

Started Aug 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Aug 2024Nov 2029

First Submitted

Initial submission to the registry

August 12, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

August 20, 2024

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2029

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

4.2 years

First QC Date

August 12, 2024

Last Update Submit

February 11, 2026

Conditions

Outcome Measures

Primary Outcomes (9)

  • Cyber-Sexual Harassment survey score

    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

    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

    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

    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

    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

    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

    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

    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

    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 Outcomes (5)

  • Personal Beliefs and Social Norms about Gender Based Violence as assessed by the Social Norms and Beliefs about Gender Based Violence Scale

    9 and 12 months

  • Gender equality survey score

    9 and 12 months

  • IPV acceptability survey score

    9 and 12 months

  • Sexual and reproductive health knowledge and empowerment score

    9 and 12 months

  • Confidence in service providers (adolescents and adults) score

    9 and 12 months

Study Arms (2)

Communities Care

EXPERIMENTAL

Districts in two regions of Somalia randomized to Communities Care violence prevention program with adults and adolescents

Behavioral: Communities Care

Control

NO INTERVENTION

Districts in two regions of Somalia randomized to control - usual programming related to prevention of violence

Interventions

Communities Care is a violence prevention program targeting social norms and behavioral change

Communities Care

Eligibility Criteria

Age10 Years - 100 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-identified as male and female adolescents and adults
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Less than 10 years old
  • Not a participant in CC adult or CC adolescent
  • Not a resident of target districts-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CISP Somalia

Mogadishu, Wadajir District, Somalia

RECRUITING

Study Officials

  • Nancy Glass, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Glass, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized at the districts level in two regions of Somalia
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2024

First Posted

August 15, 2024

Study Start

August 20, 2024

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

November 1, 2029

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations