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

NCT ID: NCT04125251

Last Updated: 2022-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1696 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-21

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Empowerment Domestic Violence Depression Self Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The intervention and the assessment will be carried out parallel in the intervention and the control arm.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
The participants, LSB providers and the outcomes assessors will not be having knowledge regarding the outcomes being assessed.

Study Groups

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BISP,CT & LSB to Couples

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

Group Type ACTIVE_COMPARATOR

Life Skills Building Training

Intervention Type 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 Women

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

Group Type ACTIVE_COMPARATOR

Life Skills Building Training

Intervention Type 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 & No LSB

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aga Khan University

OTHER

Sponsor Role lead

Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

Benazir Income Support Programme (BISP)

OTHER

Sponsor Role collaborator

Responsible Party

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Dr Zulfiqar Ahmed Bhutta

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zulfiqar ZB Bhutta, PhD

Role: PRINCIPAL_INVESTIGATOR

The Aga Khan University, Karachi, Pakistan

Rozina RK Karmaliani, PhD

Role: STUDY_DIRECTOR

The Aga Khan University, Karachi, Pakistan

tazeen TS Ali, PhD

Role: STUDY_DIRECTOR

The Aga Khan University, Karachi, Pakistan

Locations

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The Aga Khan University

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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OPP1148892

Identifier Type: -

Identifier Source: org_study_id

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