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CompletedNCT04125251MEWEUpdated Feb 21, 2022

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

An interventional study of Life Skills Building Training in Empowerment, Domestic Violence and Depression, sponsored by Aga Khan University. Completed at 1 site in Pakistan. Open to participants aged 15 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-21.

Sponsored by Aga Khan University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,696
Allocation
Randomized
Ages
15 Years to 49 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Empowerment
  • Domestic Violence
  • Depression
  • Self Efficacy

Keywords

  • Maternal Depression
  • Women Empowerment
  • Life Skills Building
03

In context

Empowerment

46 studies on the registry are indexed under Empowerment; 18 are open to participants now.

This study's enrollment of 1,696 is above the median of 120 across 41 interventional studies indexed under Empowerment.

Browse Empowerment studies →

Lead sponsor

Aga Khan University is the lead sponsor of 293 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Gross mental impairment in either of the partners
  • Either of the partner is physically challenged or bedridden
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
1,696 participants (actual)

Study arms

  • Active comparator
    BISP,CT & LSB to Couples

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

    Behavioral: Life Skills Building Training

  • Active comparator
    BISP,CT & LSB to Women

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

    Behavioral: Life Skills Building Training

  • No intervention
    BISP,CT & No LSB

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

Interventions

  • BehavioralLife 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

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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).

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

  3. 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.

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

Secondary outcomes

  1. 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.

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

  2. 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).

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

  3. 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.

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

07

Study locations

1 site
  • The Aga Khan University
    Karachi, Sindh 74800, Pakistan
08

References and documents

Study documents

  • Study protocol · Jan 20, 2021
  • Informed consent form · Jul 19, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — The IPD will be analyzed using unique identifiers and only the study results will be shared through publications

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2019 to primary completion in Apr 2021, 18 months.

Of 26 interventional studies with no phase under Empowerment, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's 18 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 3, 2019
First posted
Oct 14, 2019
StartActual
Oct 21, 2019
Primary completionActual
Apr 30, 2021
CompletionActual
Dec 31, 2021
Last update
Feb 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04125251
Collaborators
Bill and Melinda Gates Foundation, Benazir Income Support Programme (BISP)
Responsible party
Dr Zulfiqar Ahmed Bhutta (Professor, Aga Khan University) — Principal investigator
First posted
Oct 14, 2019
Start date
Oct 21, 2019
Primary completion
Apr 30, 2021
Completion
Dec 31, 2021
Last update
Feb 21, 2022

Study contacts

Zulfiqar ZB Bhutta, PhD
principal investigator · The Aga Khan University, Karachi, Pakistan
Rozina RK Karmaliani, PhD
study director · The Aga Khan University, Karachi, Pakistan
tazeen TS Ali, PhD
study director · The Aga Khan University, Karachi, Pakistan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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