EmpowermentMEWENCT04125251

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

A study testing Life Skills Building Training in people with Empowerment and Domestic Violence, run by Aga Khan University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 15 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Empowerment, Domestic Violence, Depression
What is being tested?: Life Skills Building Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,696 participants
Where: 1 sitePakistan
Study dates: 21 Oct 2019to 31 Dec 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 49 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

The Aga Khan University
Karachi, Sindh, 74800

Other trials in Pakistan

About this study

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

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.

Conditions: Empowerment, Domestic Violence, Depression, Self Efficacy
Being tested: Life Skills Building Training
Keywords: Maternal Depression, Women Empowerment, Life Skills Building
Medical subject headings: Empowerment, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Life Skills Building TrainingBehavioural
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

Study groups in NCT04125251
Study group	Role	What they receive
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 Receives: 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. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Oct 201931 Dec 2021

First posted14 Oct 2019
Study start21 Oct 2019
Primary completion30 Apr 2021
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for EmpowermentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: The intervention and the assessment will be carried out parallel in the intervention and the control arm.
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 1,696 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04125251
Sponsor's protocol ID: OPP1148892
Acronym: MEWE
Status last verified: Feb 2022
First submitted: 3 Oct 2019
Last updated: 21 Feb 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The IPD will be analyzed using unique identifiers and only the study results will be shared through publications

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Supporting Women and Girls in Pakistan: Scaling Up Empowerment and Care Strategies to Address Health and Survival
ClinicalTrials.gov ID: NCT04125251
Acronym / sponsor ID: MEWE / OPP1148892
Conditions: Empowerment, Domestic Violence, Depression, Self Efficacy
Keywords: Maternal Depression, Women Empowerment, Life Skills Building
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,696 participants (actual)
Lead sponsor: Aga Khan UniversityUniversity, hospital or other
Collaborators: Bill and Melinda Gates Foundation, Benazir Income Support Programme (BISP)
Study start: 21 Oct 2019 (actual)
Primary completion: 30 Apr 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 14 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 3
Model description: The intervention and the assessment will be carried out parallel in the intervention and the control arm.

Arm	Type	Receives
BISP,CT & LSB to Couples	Active comparator	Behavioral: Life Skills Building TrainingIn this arm 1, the LSB intervention will be offered to the BISP-CT beneficiary women and their spouses
BISP,CT & LSB to Women	Active comparator	Behavioral: Life Skills Building TrainingIn this arm, the LSB intervention will be offered to the BISP-CT beneficiary women only.
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

Who may qualify

Ages: 15 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Life Skills Building TrainingThe 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	Behavioural	BISP,CT & LSB to Couples, BISP,CT & LSB to Women

Primary outcome

Decreased Maternal Depression
Time frame: Base-line, and End-line (5 months post-intervention)
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.
Decreased Domestic Violence
Time frame: Base-line, and End-line (5 months post-intervention)
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).
Improved General Self-Efficacy
Time frame: Base-line, and End-line (5 months post-intervention)
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.

3 secondary outcomes

Improved Household Food Security
Time frame: Base-line, and End-line (5 months post-intervention)
Increased Resilience
Time frame: Base-line, and End-line (5 months post-intervention)
Improved Gender Attitude
Time frame: Base-line, and End-line (5 months post-intervention)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
Individual participant dataSharing planned: No. The IPD will be analyzed using unique identifiers and only the study results will be shared through publications

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Life Skills Building Training in people with Empowerment and Domestic Violence, run by Aga Khan University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decreased Maternal Depression (time frame: Base-line, and End-line (5 months post-intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04125251.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2022.