Intimate Partner Violence (IPV)NCT06735417
Impacts of the Indashyikirwa Program on Intimate Partner Violence in Syria
A study testing Indashyikirwa program in people with Intimate Partner Violence (IPV) and Well-being/Quality of Life, run by International Security and Development Center gGmbH at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence (IPV), Well-being/Quality of Life, Decision Making
- What is being tested?
- Indashyikirwa program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteSyria
- Study dates
- 3 Nov 2024to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Villages or individuals not meeting the inclusion criteria.
- Women who are unmarried, divorced, or widowed.
- Women who do not reside with their husbands in the same household.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impacts of the Indashyikirwa Program on Reducing and Preventing Intimate Partner Violence: Evidence from a Randomized Controlled Trial in Syria
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.
Read more
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.
- Conditions
- Intimate Partner Violence (IPV), Well-being/Quality of Life, Decision Making, Gender-Based Violence, Gender Equality, Gender Role
- Being tested
- Indashyikirwa program
- Keywords
- Syria, Heterosexual couple, Gender transformative approach, Conflict settings, Randomised controlled trial, Couple curriculum
- Medical subject headings
- Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indashyikirwa programBehavioural
Also called Couple Curriculum
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Indashyikirwa program |
| Control group | No intervention | This arm is the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 months, 12 months and 24 months post-intervention
Secondary outcomes (10)
Changes in the level of conflict in intimate relationships over time
The frequencies of quarrels in the past 12 months, as reported separately by male and female participants
Measured: 2 months, 12 months and 24 months post-intervention
Changes in the level of marriage satisfaction among couples over time
The reported level of current satisfaction with the marital relationship, as reported separately by male and female participants
Measured: 2 months, 12 months and 24 months post-intervention
Extent of relationship quality with the partner
Frequency of self-reported experience of trust, care, and respect with the partner, separately for female and male participants
Measured: 2 months, 12 months, and 24 months post-intervention
Level of women involvement in intra-household decision-making
Number of women reporting their ability to make household decisions alone or jointly with their husband, separately for male and female participants
Measured: 2 months, 12 months, and 24 months post-intervention
Extent of spousal support in women's business
Frequency of women's reporting husband's support for their business or economic activities
Measured: 2 months, 12 months, and 24 months post-intervention
Level of women's self-efficacy in economic activities
Frequency of women agreeing with statements on current self-efficacy and confidence in managing business tasks
Measured: 2 months, 12 months, and 24 months post-intervention
Extent of women's mobility and decision-making autonomy
Number of women requiring their husband's permission to access work or health services
Measured: 2 months, 12 months, and 24 months post-intervention
Extent of peer support to women
Number of peers offering direct support to women, as reported by female participants
Measured: 2 months, 12 months, and 24 months post-intervention
Assessing current level of positive well-being among couples
The self-reported level of well-being among women and men, as measured in the survey using the Pearlin Mastery Scale
Measured: 2 months, 12 months, and 24 months post-intervention
Changes in the extent of agreement to favorable gender norms over time
The level of agreement on acceptable gender norms in the home and society, as reported separately by male and female participants
Measured: 2 months, 12 months, and 24 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start3 Nov 2024
- Primary completion30 Oct 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate Partner Violence (IPV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Security and Development Center gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Humboldt-Universität zu Berlin, Syria Resilience Initiative (SRI), United Kingdom Foreign Commonwealth Development Office
- Responsible party
- Principal investigator, Ghassan Baliki, International Security and Development Center gGmbH
- Investigators
- Tilman Brück, PhD, Study chair, International Security and Development Center gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735417
- Sponsor's protocol ID
- 2024-14-AlDaccache
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of the Indashyikirwa Program on Reducing and Preventing Intimate Partner Violence: Evidence from a Randomized Controlled Trial in Syria
- ClinicalTrials.gov ID
- NCT06735417
- Acronym / sponsor ID
- 2024-14-AlDaccache
- Conditions
- Intimate Partner Violence (IPV), Well-being/Quality of Life, Decision Making, Gender-Based Violence, Gender Equality, Gender Role
- Keywords
- Syria, Heterosexual couple, Gender transformative approach, Conflict settings, Randomised controlled trial, Couple curriculum
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- International Security and Development Center gGmbHUniversity, hospital or other
- Collaborators
- Humboldt-Universität zu Berlin, Syria Resilience Initiative (SRI), United Kingdom Foreign Commonwealth Development Office
- Study start
- 3 Nov 2024 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indashikirwa program | Experimental | Behavioral: Indashyikirwa programThe 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. |
| Control group | No intervention | –This arm is the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Villages or individuals not meeting the inclusion criteria.
- Women who are unmarried, divorced, or widowed.
- Women who do not reside with their husbands in the same household.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indashyikirwa programAlso: Couple CurriculumIndashyikirwa 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. | Behavioural | Indashikirwa program |
Primary outcome
Changes in intimate partner violence incidence over time
Time frame: 2 months, 12 months and 24 months post-intervention
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
Changes in acceptability of wife beating over time
Time frame: 2 months, 12 months and 24 months post-intervention
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
10 secondary outcomes
Changes in the level of conflict in intimate relationships over time
Time frame: 2 months, 12 months and 24 months post-intervention
Changes in the level of marriage satisfaction among couples over time
Time frame: 2 months, 12 months and 24 months post-intervention
Extent of relationship quality with the partner
Time frame: 2 months, 12 months, and 24 months post-intervention
Level of women involvement in intra-household decision-making
Time frame: 2 months, 12 months, and 24 months post-intervention
Extent of spousal support in women's business
Time frame: 2 months, 12 months, and 24 months post-intervention
Level of women's self-efficacy in economic activities
Time frame: 2 months, 12 months, and 24 months post-intervention
Extent of women's mobility and decision-making autonomy
Time frame: 2 months, 12 months, and 24 months post-intervention
Extent of peer support to women
Time frame: 2 months, 12 months, and 24 months post-intervention
Assessing current level of positive well-being among couples
Time frame: 2 months, 12 months, and 24 months post-intervention
Changes in the extent of agreement to favorable gender norms over time
Time frame: 2 months, 12 months, and 24 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tilman Brück, PhD study chair
International Security and Development Center gGmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indashyikirwa program in people with Intimate Partner Violence (IPV) and Well-being/Quality of Life, run by International Security and Development Center gGmbH at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in intimate partner violence incidence over time (time frame: 2 months, 12 months and 24 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.