RCT of the Effectiveness of the WfWI Intervention in Afghanistan

Depressive Symptoms Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03236948
• Other study ID #: EC034-11-2015
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 28, 2017
• Last updated: July 28, 2017
• Start date: October 2016
• Est. completion date: November 2018

Study information

• Verified date: July 2017
• Source: Medical Research Council, South Africa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1461
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Domestic Violence
• Livelihoods

Intervention

Behavioral:
• Women for Women International Intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical Research Council, South Africa	Women for Women International (WfWI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	22 months post baseline
Primary	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.	22 months post baseline
Primary	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.	22 months post baseline
Secondary	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.	22 months post baseline
Secondary	Financial shock resilience	One item assesses ability to mobilise cash in an emergency.	22 months post baseline
Secondary	Monthly earnings	A single item assesses women's past month earnings	22 months post baseline
Secondary	Total savings	A single item assesses women's total savings	22 months post baseline
Secondary	Life satisfaction	Life satisfaction is assessed using four-items derived from the Satisfaction With Life Scale. A mean score is produced.	22 months post baseline
Secondary	Suicidal ideation in past 4 weeks	A single item assesses thoughts about suicide in past week.	22 months post baseline
Secondary	Gender attitudes	11 questions assess women's gender attitudes. A mean score is created.	22 months post baseline
Secondary	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.	22 months post baseline
Secondary	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.	22 months post baseline
Secondary	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	22 months post baseline
Secondary	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.	22 months post baseline
Secondary	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	22 months post baseline