NCT06735417

Brief Summary

This study aims to evaluate the effectiveness of the Indashyikirwa program in enhancing women's empowerment and reducing Intimate Partner Violence (IPV) in conflict-affected communities in Northeast Syria. The intervention group will participate in the Indashyikirwa ("Agents of Change") program, which includes a comprehensive couples' training module and access to safe spaces. The control group will not receive the Indashyikirwa program. Both intervention and control groups are beneficieries of Small and Medium Enterprise (SME) support and Vocational Training (VT) to promote economic empowerment. The study employs a cluster-randomized controlled trial (cRCT) design. Out of 30 pre-identified villages, 15 villages were randomly assigned to receive the Indashyikirwa program and 15 villages will not receive the Indashyikirwa program. The villages were located within the same sub-districts to ensure a balanced geographic distribution of the intervention. Based on a power analysis with 80% power, at least 16 married couples from eligible SME and VT beneficiaries will be voluntarily enrolled in each village to receive the Indashyikirwa intervention. Similarly, 16 eligible SME and VT married couples from control villages will be enrolled using the same voluntary participation principle. To account for potential attrition, 20 couples per village will be initially enrolled, ensuring a robust sample size for analysis. This approach results in a total sample size of 600 couples (or 1,200 individual participants). The primary objective of this study is to assess the impact of Indashyikirwa program on key outcomes, including the reduction in IPV, transformation of gender norms, enhancement of women's empowerment, improvements in intra-household dynamics, economic benefits to the household. Data collection will involve structured surveys administered separately to both husbands and wives. Surveys will be conducted at four time points: baseline, 2 months post-intervention, 12 months post-intervention, and 24 months post-intervention.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Progress48%
Nov 2024Jan 2028

Study Start

First participant enrolled

November 3, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 5, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

December 5, 2024

Last Update Submit

December 13, 2024

Conditions

Keywords

SyriaHeterosexual coupleGender transformative approachConflict settingsRandomised controlled trialCouple curriculum

Outcome Measures

Primary Outcomes (2)

  • Changes in intimate partner violence incidence over time

    Frequency of women experience or man perpetration of economic, physical, and emotional IPV as assessed by the standardized Demographic and Health Survey (DHS) in the past 12 months

    2 months, 12 months and 24 months post-intervention

  • Changes in acceptability of wife beating over time

    Number of justifications for wife beating as assessed by the standardized Demographic and Health Survey (DHS) in the past 12 months, as reported by female participants

    2 months, 12 months and 24 months post-intervention

Secondary Outcomes (10)

  • Changes in the level of conflict in intimate relationships over time

    2 months, 12 months and 24 months post-intervention

  • Changes in the level of marriage satisfaction among couples over time

    2 months, 12 months and 24 months post-intervention

  • Extent of relationship quality with the partner

    2 months, 12 months, and 24 months post-intervention

  • Level of women involvement in intra-household decision-making

    2 months, 12 months, and 24 months post-intervention

  • Extent of spousal support in women's business

    2 months, 12 months, and 24 months post-intervention

  • +5 more secondary outcomes

Other Outcomes (3)

  • Changes in household earnings over time

    2 months, 12 months, and 24 months post-intervention

  • Changes in household food security status over time

    2 months, 12 months, and 24 months post-intervention

  • Changes in household coping strategies over time

    2 months, 12 months, and 24 months post-intervention

Study Arms (2)

Indashikirwa program

EXPERIMENTAL

The group will receive the Indashikirwa program, which includes: 1. Couple curriculum training for both husbands and wives. These sessions focus on promoting joint decision-making and transforming gender norm to promote healthier and more equitable relationships. 2. Establishment of safe spaces to foster community support and facilitate dialogue around gender-based issues.

Behavioral: Indashyikirwa program

Control group

NO INTERVENTION

This arm is the control group

Interventions

Indashyikirwa training curriculum is delivered to heterosexual married couples in Syrian communities in Al-Hasakah governorate. The curriculum includes between 21 and 22 sessions, delivered to groups of up to 30 couples. Each week, participants will attend one session, lasting at least 3 hours. Topics covered include: gender, power imbalance, triggers for GBV, conflict management, building healthy relationships, and coping mechanisms for managing GBV-related triggers. The curriculum is designed to address both the wife and her husband and includes interactive exercises, take-home assignments, and reflections. The sessions are delivered by trained facilitators.

Also known as: Couple Curriculum
Indashikirwa program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Women who are unmarried, divorced, or widowed.
  • Women who do not reside with their husbands in the same household.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syria Resilience Initiative

Al-Hasakah, Al-Hasakah Governorate, Syria

Location

MeSH Terms

Conditions

Empowerment

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Tilman Brück, PhD

    International Security and Development Center gGmbH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research program director

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 16, 2024

Study Start

November 3, 2024

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

December 16, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Due to the sensitive nature of the data collected and the vulnerable context of the participants, IPD will not be shared to ensure confidentiality and safety of participants. The study complies with ethical guidelines and prioritizes safeguarding participants' privacy over data-sharing considerations.

Locations