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

NCT04125251 | Completed

• 1 other identifier: OPP1148892
• Study Type: interventional
• Target: 1,696
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Empowerment; Domestic Violence; Depression; Self Efficacy

Keywords

Maternal Depression; Women Empowerment; Life Skills Building

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (3)

• Improved Household Food Security

  Base-line, and End-line (5 months post-intervention)

• Increased Resilience

  Base-line, and End-line (5 months post-intervention)

• Improved Gender Attitude

  Base-line, and End-line (5 months post-intervention)

Study Arms (3)

BISP,CT & LSB to Couples

ACTIVE COMPARATOR

In this arm 1, the LSB intervention will be offered to the BISP-CT beneficiary women and their spouses

Behavioral: Life Skills Building Training

BISP,CT & LSB to Women

ACTIVE COMPARATOR

In this arm, the LSB intervention will be offered to the BISP-CT beneficiary women only.

Behavioral: Life Skills Building Training

BISP,CT & No LSB

NO INTERVENTION

This is the control group, where neither BISP-CT beneficiary women nor their spouses will be offered the LSB intervention

Interventions

Life Skills Building Training BEHAVIORAL

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

BISP,CT & LSB to Couples; BISP,CT & LSB to Women

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: The couples will be recruited from the list of adult women who are receiving Benazir Income Support Program (BISP) Cash Transfer (CT) and meet the eligibility criteria
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aga Khan University: lead
• Bill and Melinda Gates Foundation: collaborator
• Benazir Income Support Programme (BISP): collaborator

Study Sites (1)

The Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Empowerment; Depression

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Behavioral Symptoms

Study Officials

• Zulfiqar ZB Bhutta, PhD

  The Aga Khan University, Karachi, Pakistan

  PRINCIPAL INVESTIGATOR

• Rozina RK Karmaliani, PhD

  The Aga Khan University, Karachi, Pakistan

  STUDY DIRECTOR

• tazeen TS Ali, PhD

  The Aga Khan University, Karachi, Pakistan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participants, LSB providers and the outcomes assessors will not be having knowledge regarding the outcomes being assessed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The intervention and the assessment will be carried out parallel in the intervention and the control arm.

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 14, 2019
• Study Start: October 21, 2019
• Primary Completion: April 30, 2021
• Study Completion: December 31, 2021
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)