Men Engagement in Women Empowerment for Improving Maternal Mental Health Through Cash Transfer and Life Skills Building

Depression Clinical Trial

— MEWE  

Official title:

Supporting Women and Girls in Pakistan: Scaling Up Empowerment and Care Strategies to Address Health and Survival

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04125251
• Other study ID #: OPP1148892
• Status: Completed
• Phase: N/A
• Start date: October 21, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project aims to offer Life Skills Building (LSB) intervention to Benazir Income Support Program (BISP) Cash Transfer (CT) beneficiaries in couples in order to reduce domestic violence and depression and improve women empowerment in married women of reproductive age. The intervention will be carried out in the rural settlements of district Thatta, Sindh Pakistan.

Description:

The study will assess the impact of Life Skill Building (LSB) to Benazir Income support Program (BISP) Cash Transfer (CT) beneficiaries and their husbands in improving maternal mental and child health and its combined effect in empowering women and couples. The Formative phase of the project was dedicated for the development and modification of National level LSB curriculum for men and women. The formative phase was carried out in Thatta (Sindh), Rahimyar Khan (Punjab), Lasbela (Baluchistan) and Peshawar (KPK). The intervention phase will be conducted in district Thatta, where BISP beneficiaries along with their spouses will be offered a LSB training. This intervention will be offered by community teachers to ensure sustainability and community trust. The participants will be recruited for baseline assessment followed by a comprehensive LSB intervention.The end-line follow up assessments (five months of intervention) will be done after the deliver of intervention. A qualitative summative inquiry will be done at the completion of the project to explore the overall impact of the LSB intervention. Since the project is being implemented with the BISP, the cost of intervention can be estimated for the scalability and sustainability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1696
• Est. completion date: December 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 49 Years

Eligibility

Inclusion Criteria:

• Adult married couples living together: where women receive Benazir Income Support Program (BISP) Cash Transfer (CT), have one child of at least 18 months and have no family migration plan for next 2 years

Exclusion Criteria:

• Gross mental impairment in either of the partners
• Either of the partner is physically challenged or bedridden

Related Conditions & MeSH terms

• Depression
• Domestic Violence
• Empowerment
• Self Efficacy

Intervention

Behavioral:
• Life Skills Building Training
The Life Skills Building intervention is a curriculum based on 10-12 sessions. The sessions will include the skills essential for family harmony and improving overall mental health of the participants

Locations

Country	Name	City	State
Pakistan	The Aga Khan University	Karachi	Sindh

Sponsors (3)

Lead Sponsor	Collaborator
Aga Khan University	Benazir Income Support Programme (BISP), Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased Maternal Depression	The Patient Health Questionnaire (PHQ) is a self-administered instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day), over the last two weeks.; PHQ-9 total score for the nine items ranges from 0 to 27. Scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression, respectively.	Base-line, and End-line (5 months post-intervention)
Primary	Decreased Domestic Violence	The revised conflict tactics scale (CTS) consists of 20-item and is self-administered. The scale includes items regarding Negotiation (1-4), Psychological aggression (5-8), Physical assault (9-12), Sexual coercion (13-16) and Injury (17-20). The scoring criteria consists of a scale from 1-8, 1-6 indicates the frequency of conflict happened in the past year ranging from once to more than 20 times. 7 indicates conflict happened not in the past year but happened before that. If it never happened, 8 will be marked.; There are many ways to score the CTS: Respondents who reported being a victim of or perpetrating an item or items (Prevalence). The number of times an item occurred in the past year (Frequency). Classifying each case into three categories: none, minor only, or severe (severity level). Classifying each case as respondent only, partner only, or both (mutuality types).	Base-line, and End-line (5 months post-intervention)
Primary	Improved General Self-Efficacy	The General Self-Efficacy Scale (GSE) is a 10-item instrument to assess a general sense of perceived self-efficacy with the aim to predict coping and adaptation after stressful life events. Responses to each item are made on a 4-point scale: 1=Not at all true, 2=Hardly true, 3=moderately true, 4=exactly true.; For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.	Base-line, and End-line (5 months post-intervention)
Secondary	Improved Household Food Security	A six-item food security questionnaire (FSQ) is used to assess the food security in a household. The scale is valid, reliable and sensitive screening tool of food security in the household in the last 4 weeks, and whether the household was able to afford the food they needed.; The total score ranges between 0-6, where score 0-1 shows high or marginal food security, score 2-4 shows low food security, score 5-6 shows very low food security.	Base-line, and End-line (5 months post-intervention)
Secondary	Increased Resilience	The validated Wagnild's resilience scale in Pakistani context will be used. The resilience scale comprise of five core characteristics of resilience that include: purposeful life, perseverance, equanimity, self-reliance and existential loneliness. It comprise of validated 14 items with 7-point Likert scale to rate the individual's evaluation ranging from 1 (Strongly Disagree) to 7 (Strongly Agree).; Item scores are summed to yield a total score ranging from 14 to 98, with higher scores suggestive of greater perceived resilience categorized as very low (14-56), low (57-64), on the low end (65-73), moderate (74-81), moderately high (82-90), and high (91-98).	Base-line, and End-line (5 months post-intervention)
Secondary	Improved Gender Attitude	The Gender Equitable Attitude Scale (GEAS) is a 21 item Likert scale ranging from 4 (strongly agree) to 1 (strongly disagree). It has been adapted from 34-item original "The Gender-Equitable Men Scale (GEM Scale)" and 13-item "Gender Equitable Men Scale" adapted in the context of Pakistan. The total score ranges from 21-84, where higher score shows more gender equitable attitudes.	Base-line, and End-line (5 months post-intervention)