RCT of the Effectiveness of the WfWI Intervention in Afghanistan
Primary Purpose
Domestic Violence, Depressive Symptoms, Livelihoods
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Women for Women International Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Domestic Violence
Eligibility Criteria
Inclusion Criteria:
- Women should be in the lowest economic level (earning less than US$1.25/day)
- Unemployed
- No in education/school
- Not involved in a similar programme
- Able to provide informed consent
Exclusion Criteria:
- Not mentally incapacitated, so as unable to provide informed consent
- Already been part of the WfWI intervention previously
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
WfWI Intervention
Control
Arm Description
Women receive the WfWI intervention. This comprises of three main components. First, a social empowerment and health intervention. Second a livelihood strengthening intervention, including numeracy training, and vocational training. Third, a cash transfer conditional on attendance at the intervention to cover costs of attendance and provide start-up capital. The intervention is delivered over 12 months.
Outcomes
Primary Outcome Measures
Any past year physical intimate partner violence experienced amongst currently married women
Physical intimate partner violence is assessed using five items based on the WHO VAW scale. A positive response to any item leads to a person being classified as experiencing in the past year.
Past year severe physical intimate partner violence experience amongst currently married women
Severe physical intimate partner violence experience is assessed using 5 items. Past year severe physical IPV is assessed as positive if a person responds to two (or more) items as once, or one item as few (or more), essentially creating a more than once categorization.
Depressive symptomology
Past week depressive symptomology is assessed by the Centre for Epidemiological Studies Depression (CESD) scale, with the full twenty items. A mean score will be calculated.
Secondary Outcome Measures
Household food insecurity in past four weeks
Three items ask about household level food insecurity in the past 4 weeks. A mean score is calculated.
Financial shock resilience
One item assesses ability to mobilise cash in an emergency.
Monthly earnings
A single item assesses women's past month earnings
Total savings
A single item assesses women's total savings
Life satisfaction
Life satisfaction is assessed using four-items derived from the Satisfaction With Life Scale. A mean score is produced.
Suicidal ideation in past 4 weeks
A single item assesses thoughts about suicide in past week.
Gender attitudes
11 questions assess women's gender attitudes. A mean score is created.
Married women's participation in household decision-making
Five items are asked about women's ability to participate in household decisions. A mean score is created.
Any emotional abuse in the past year amongst currently married women
Seven items assess emotional abuse in the past year. A mean score is calculated.
Perceptions of husband cruelty amongst currently married women
Five items ask about married women's perceptions of her husband and his attitudes and relationship towards her. A mean score is created
Mother-in-law or abuse in the past 12 months amongst currently married women
A single item assesses whether mother-in-laws have hit the woman in the past 12 months and another item assesses whether siblings have hit the woman in the past 12 months, an affirmative response to either item would indicate abuse.
Perceptions of mother-in-law cruelty amongst currently married women
For married women, six items ask about their relationship and the mother-in-laws attitudes towards her
Full Information
NCT ID
NCT03236948
First Posted
July 28, 2017
Last Updated
July 28, 2017
Sponsor
Medical Research Council, South Africa
Collaborators
Women for Women International (WfWI)
1. Study Identification
Unique Protocol Identification Number
NCT03236948
Brief Title
RCT of the Effectiveness of the WfWI Intervention in Afghanistan
Official Title
Individually Randomised Control Trial Evaluation of the Effectiveness of the Women for Women International (WfWI) Intervention in Afghanistan for Intimate Partner Violence Prevention Among Married Women
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Research Council, South Africa
Collaborators
Women for Women International (WfWI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an individually randomised control trial to assess the effectiveness of a livelihoods and social empowerment intervention, delivered by Women for Women International, on married women's experiences of intimate partner violence in Afghanistan. It has a 22 month follow up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Domestic Violence, Depressive Symptoms, Livelihoods
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Individual level randomised trial, with intervention and control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1461 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WfWI Intervention
Arm Type
Experimental
Arm Description
Women receive the WfWI intervention. This comprises of three main components. First, a social empowerment and health intervention. Second a livelihood strengthening intervention, including numeracy training, and vocational training. Third, a cash transfer conditional on attendance at the intervention to cover costs of attendance and provide start-up capital. The intervention is delivered over 12 months.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Women for Women International Intervention
Primary Outcome Measure Information:
Title
Any past year physical intimate partner violence experienced amongst currently married women
Description
Physical intimate partner violence is assessed using five items based on the WHO VAW scale. A positive response to any item leads to a person being classified as experiencing in the past year.
Time Frame
22 months post baseline
Title
Past year severe physical intimate partner violence experience amongst currently married women
Description
Severe physical intimate partner violence experience is assessed using 5 items. Past year severe physical IPV is assessed as positive if a person responds to two (or more) items as once, or one item as few (or more), essentially creating a more than once categorization.
Time Frame
22 months post baseline
Title
Depressive symptomology
Description
Past week depressive symptomology is assessed by the Centre for Epidemiological Studies Depression (CESD) scale, with the full twenty items. A mean score will be calculated.
Time Frame
22 months post baseline
Secondary Outcome Measure Information:
Title
Household food insecurity in past four weeks
Description
Three items ask about household level food insecurity in the past 4 weeks. A mean score is calculated.
Time Frame
22 months post baseline
Title
Financial shock resilience
Description
One item assesses ability to mobilise cash in an emergency.
Time Frame
22 months post baseline
Title
Monthly earnings
Description
A single item assesses women's past month earnings
Time Frame
22 months post baseline
Title
Total savings
Description
A single item assesses women's total savings
Time Frame
22 months post baseline
Title
Life satisfaction
Description
Life satisfaction is assessed using four-items derived from the Satisfaction With Life Scale. A mean score is produced.
Time Frame
22 months post baseline
Title
Suicidal ideation in past 4 weeks
Description
A single item assesses thoughts about suicide in past week.
Time Frame
22 months post baseline
Title
Gender attitudes
Description
11 questions assess women's gender attitudes. A mean score is created.
Time Frame
22 months post baseline
Title
Married women's participation in household decision-making
Description
Five items are asked about women's ability to participate in household decisions. A mean score is created.
Time Frame
22 months post baseline
Title
Any emotional abuse in the past year amongst currently married women
Description
Seven items assess emotional abuse in the past year. A mean score is calculated.
Time Frame
22 months post baseline
Title
Perceptions of husband cruelty amongst currently married women
Description
Five items ask about married women's perceptions of her husband and his attitudes and relationship towards her. A mean score is created
Time Frame
22 months post baseline
Title
Mother-in-law or abuse in the past 12 months amongst currently married women
Description
A single item assesses whether mother-in-laws have hit the woman in the past 12 months and another item assesses whether siblings have hit the woman in the past 12 months, an affirmative response to either item would indicate abuse.
Time Frame
22 months post baseline
Title
Perceptions of mother-in-law cruelty amongst currently married women
Description
For married women, six items ask about their relationship and the mother-in-laws attitudes towards her
Time Frame
22 months post baseline
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women should be in the lowest economic level (earning less than US$1.25/day)
Unemployed
No in education/school
Not involved in a similar programme
Able to provide informed consent
Exclusion Criteria:
Not mentally incapacitated, so as unable to provide informed consent
Already been part of the WfWI intervention previously
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Jewkes, PhD
Organizational Affiliation
Director Gender and Health Research Unit
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32201622
Citation
Gibbs A, Corboz J, Chirwa E, Mann C, Karim F, Shafiq M, Mecagni A, Maxwell-Jones C, Noble E, Jewkes R. The impacts of combined social and economic empowerment training on intimate partner violence, depression, gender norms and livelihoods among women: an individually randomised controlled trial and qualitative study in Afghanistan. BMJ Glob Health. 2020 Mar 16;5(3):e001946. doi: 10.1136/bmjgh-2019-001946. eCollection 2020.
Results Reference
derived
PubMed Identifier
31393873
Citation
Gibbs A, Said N, Corboz J, Jewkes R. Factors associated with 'honour killing' in Afghanistan and the occupied Palestinian Territories: Two cross-sectional studies. PLoS One. 2019 Aug 8;14(8):e0219125. doi: 10.1371/journal.pone.0219125. eCollection 2019.
Results Reference
derived
PubMed Identifier
29724222
Citation
Gibbs A, Corboz J, Jewkes R. Factors associated with recent intimate partner violence experience amongst currently married women in Afghanistan and health impacts of IPV: a cross sectional study. BMC Public Health. 2018 May 3;18(1):593. doi: 10.1186/s12889-018-5507-5.
Results Reference
derived
PubMed Identifier
29357843
Citation
Gibbs A, Corboz J, Shafiq M, Marofi F, Mecagni A, Mann C, Karim F, Chirwa E, Maxwell-Jones C, Jewkes R. An individually randomized controlled trial to determine the effectiveness of the Women for Women International Programme in reducing intimate partner violence and strengthening livelihoods amongst women in Afghanistan: trial design, methods and baseline findings. BMC Public Health. 2018 Jan 22;18(1):164. doi: 10.1186/s12889-018-5029-1.
Results Reference
derived
Learn more about this trial
RCT of the Effectiveness of the WfWI Intervention in Afghanistan
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