Supporting Women and Girls in Pakistan: Scaling Up Empowerment and Care Strategies to Address Health and Survival
Phase: NA
Conditions: Empowerment, Domestic Violence, Depression, Self Efficacy
Sponsor: Aga Khan University

© The Aga Khan University, Karachi, Pakistan 
 
 
 
 
 
 
Men Engagement in Women Empowerment for Improving 
Maternal Mental Health through Cash Transfer and Life Skills 
Building 
MEWE (Men Engagement in Women Empowerment) 
 
 
NCT Number: 04125251 
Date of Document: 20th Jan 2021 
 
 
 
 
 

 
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Principal Investigator: Dr. Zulfiqar A. Bhutta 
Co-Leads: Dr. Rozina Karmaliani, Dr. Tazeen Saeed Ali 
Technical Advisor/consultant: Dr. Judith McFarlane 
Co-investigators: Dr. Saima Hirani, Ms. Shireen Shehzad, Dr. Nargis Asad, Mr. Hussain Maqbool 
Research Specialists: Dr. Nasim Zahid Shah, Zahid Hyder Khuwaja 
Research Coordinator: Mr. Shiraz Lalani  
 
Center of Excellence in Women and Child Health (COE-WCH)  
School of Nursing and Midwifery (SONAM) 
The Aga Khan University, Stadium Road – Karachi 74800 
 
Funding Agency: Bill and Melinda Gates Foundation 
Investment ID: OPP1148892 
 
 

 
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Executive Summary 
Background: In developing countries, women under most circumstances are deprived of basic 
human rights of education, health, and economic independence. They remain dependent 
financially and socially on their husbands and fathers. Studies have shown that Cash Transfer (CT) 
and Life Skills Building (LSB) training reduce depression and violence and improve household 
financial situation. Interventions that combine LSB training with cash support have not been tested 
in Pakistan. The results of this study have direct implication to women in lowest income quintile 
in Pakistan  
Study Hypothesis: Introduction of LSB intervention to Benazir Income Support Program (BISP)-
CT beneficiaries in couples will reduce domestic violence and depression in married women of 
reproductive age by 20% and improve women empowerment by 20%. 
Study Objective: To measure the impact of men engagement in LSB and CT on maternal 
depression, domestic violence, improved self-efficacy and women empowerment. 
Study Design: Phase I: Formative phase  
Phase II: Cluster Randomized Controlled Trial (cRCT) 
Methodology: A two phase study will be conducted including formative phase for initial 1.5 years 
and cluster randomized controlled trial (cRCT) for 2 years. There will be three arms for cRCT. 
The first arm will receive LSB to couples and BISP-CT. The second arm will receive LSB only to 
women receiving BISP-CT. The third arm will be the control arm who will receive BISP-CT only.  
Sample Size Estimation: With baseline prevalence of depression 60% (Gadit (as cited in Ali & 
Zuberi, 2012)), we anticipate the reduction of depression by 20% in intervention arm. A total of 9 
clusters per arm would be needed over a period of two years assuming an average cluster size of 
at least 25 couples. There are three arms and 9 clusters in each arm so a total of 675 couples (225 
in each arm, 25 in each cluster). By accounting for the attrition rate of 25%, a minimal of 846 
couples (282 per arm) would be needed. 
Study Outcomes: 
Primary Outcomes: Reduced Maternal Depression and Domestic Violence, Improved Self-
Efficacy and Women Empowerment. 

 
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Secondary Outcomes: Improved Household food security, Gender Attitude, Economic Solvency 
and Resilience. 
Intervention Package: The intervention will consist of LSB training along with BISP-CT. The 
intervention will consist of LSB training to BISP-CT beneficiaries for a period of 10-12 sessions 
(10 for couples, 2 for family including mother-in-law, supporter or head of the household) for 2 
hours per week in the selected arms. The LSB package will focus on the skills essential for 
Effective Communication, Understanding Roles of Men and Women, Understanding the Power 
Dynamics, Work Life Balance and Time Management, Conflict Management, Decision Making, 
Building Self Confidence, Dealing with Abuse and Harassment, Money Management and Income 
Generation. The modules will be offered by trained LSB teachers from the community to ensure 
sustainability and community trust and allow the results of the research to continue for a longer 
time. The LSB teachers will be trained by AKU researchers to deliver the modules, delivery 
mechanisms, community mobilization and management skills along with monitory compensation 
as stipend. The LSB teachers will be offered refresher training 2-3 times on monthly basis for 
debriefing, expanded education, resource information and skill enhancement advocacy.  
The pre-intervention formative phase of the project will be of one to one and half years. The 
objectives of the formative phase are for staff recruitment, the development of operational plan 
and development of women and couple empowerment tools, planning and refinement of 
intervention, development of training modules for couples, meetings with government and 
community stakeholders, community mobilization, capacity building and networking. The LSB 
intervention will be delivered in individuals/groups in the intervention arms, after the completion 
of recruitment and baseline assessment. Once the intervention is delivered, end-line (five months 
of intervention) follow up assessments will be completed. 
 
 
 

 
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Table of Contents 
Executive Summary ........................................................................................................................ 3 
Background and Introduction ......................................................................................................... 6 
Child Survival ............................................................................................................................. 7 
Economic Empowerment to Improve Maternal Mental Health and Child Survival .................. 7 
Micro-finance or Cash Transfer as an Intervention for Women’s Economic Empowerment .... 9 
Rationale ....................................................................................................................................... 10 
Problem Statement ........................................................................................................................ 11 
Situational Analysis ...................................................................................................................... 11 
Hypothesis..................................................................................................................................... 12 
Aim and Objective ........................................................................................................................ 12 
Primary Objectives.................................................................................................................... 12 
Secondary Objectives................................................................................................................ 12 
Primary Outcomes ........................................................................................................................ 12 
Secondary Outcomes .................................................................................................................... 13 
Method .......................................................................................................................................... 13 
Program Implementation and Approach ................................................................................... 13 
Key Intervention ....................................................................................................................... 13 
Study Design ............................................................................................................................. 13 
Phase 1: Formative Research ........................................................................................................ 15 
Objectives ................................................................................................................................. 15 
Theoretical Framework: Social Ecological Model ................................................................... 15 
Study Site .................................................................................................................................. 18 
Project Initiation........................................................................................................................ 21 
Qualitative Research through Participatory Reflection and Action (PRA) .............................. 22 
Participants Recruitment and Sampling .................................................................................... 23 
Data Collection ......................................................................................................................... 23 
Data Management ..................................................................................................................... 23 
Phase 2: Cluster Randomized Control Trial ................................................................................. 24 
Inclusion and Exclusion Criteria ............................................................................................... 24 
Sample Size ............................................................................................................................... 24 
Sampling Strategy ..................................................................................................................... 25 
Operational Plan........................................................................................................................ 25 
Process Outcome Measures ...................................................................................................... 27 
Data Management ......................................................................................................................... 27 
Assessment Tools.......................................................................................................................... 28 
Data Analysis ................................................................................................................................ 31 
Communication Plan and Stakeholder Management .................................................................... 31 
Monitoring and Evaluation Plan ................................................................................................... 31 
Project Management Structure and Organization ......................................................................... 32 
Technical and Financial Reporting ............................................................................................... 32 
Ethical Considerations .................................................................................................................. 32 
References ..................................................................................................................................... 34 
 
 
 

 
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Background and Introduction  
Empowerment of women is an important component to ensure family health and economic 
development. Number of interventions have been implemented to make women economically 
independent by providing micro-finance either with or without skill building training. 
Governments and donors have been supporting Non-Governmental Organizations (NGOs) in the 
developing countries as partners in the development process to improve the economic status and 
quality of life of people living in the developing countries (Buller et al., 2018; Roy et al., 2017).  
According to WHO report of 2000, the global health burden of mental disorders has reached 
epidemic proportions, which is associated with significant burden of morbidity and disability.  
WHO 2004, further suggested depression as the third most important cause of disease burden 
worldwide. Depression is often a byproduct of domestic violence with the incidence being 
reported by 60% of the female victims. The negative consequences of maternal depression on 
children have been documented. Evidence also suggests that children who witness either partner 
violence or violence at mothers at home have greater problems with social skills and learning 
(Hurt, Malmund, Brodsky, & Giannetta, 2001; McFarlane, Groff, O’Brien, Watson, 2003). 
However, recent research studies shows that treatment of the abused and depressed mother can 
improve the functioning of the children in just six months (McFarlane, Groff, O’Brien, & 
Watson, 2005a and 2005b). Apart from affecting psychosocial wellbeing; children’s mental 
health issues such as depression and anxiety also affect reproductive health. Hampshire 
Depression Project reports articulates the positive relationship between depression and lower 
socio-economic status (Ostler & Thomson, 2001). A large scale study including 152 countries 
that aimed at assessing association between Infant Mortality Rate (IMR) and socioeconomic 
determinants found that, socio-economic variables predicted 92% of national IMR at the global 
level.  Hence, the problem of women mental health affects various aspects of her life (Schell et 
al., 2007). 
According to USAID studies, measurement of couple empowerment is difficult and there are only 
a few quantitative studies performed in this regard. However, a many qualitative studies suggest 
that the view of women within their communities changes due to their activities in microfinance 
leading to increase in their decision making capabilities and more control over resources (Todd 
1996). This microfinance or cash transfer will be further benefitted if LSB training will also be 

 
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given to the women. Life skills interventions undertaken in developed countries suggest to be 
effective in promoting positive behaviors around smoking, alcohol, drug abuse, HIV, AIDS, 
contraception, perception about sexual activities and condom use through refusal skills, 
communication skills, assertiveness, self-awareness, attitude change and safer behaviors (Teyhan 
et al., 2016; Weichold & Blumenthal, 2016). The LSB training along with microfinance will 
provide essential skills to women for better utilization of money for herself and for her family’s 
health. In order to understand the impact from the specific interventions on women, it is important 
to know where she stands in the larger picture of family dynamics and what her bargaining power 
is (Duvendack et al., 2011). 
Child Survival 
In 2012, 6.6 million children died before reaching their fifth birthday. It is a sharp decrease from 
1990, when more than 12 million children died under age five (UNICEF, 2012). Infant mortality 
and mortality of children less than five years in Pakistan emphasis that children usually die from 
malnutrition and infection cyclic syndrome. The malnutrition-infection syndrome occurs when 
young children, who are undernourished, usually die due to family food insecurity, and 
gastrointestinal infections. Child birth weight is the most important factor of children’s chances of 
survival and it is influenced by the mother’s age and her nutritional status, child’s birth weight and 
socio economic status of the mother. Current high-impact, low-cost interventions such as nutrition 
availability, and improved breastfeeding practices through economic building of the family are 
suggested interventions.   
Economic Empowerment to Improve Maternal Mental Health and Child Survival 
The health status of a woman is only improved, if special emphasis is given to her mental health.  
As a result of improvement in mother’s mental health the entire family will be less stressed and 
can obtain better cohesion and higher functioning. Although research evidence indicates an 
association between women’s mental health and domestic violence, the existing knowledge on 
associations between women’s mental health determinants, economic development and child 
health outcomes is still unclear. The link between mental health and low income amongst urban 
women has been well documented in developing countries (Blue, Ducci, Jaswal, Ludermir, & 
Harpham, 1995).  Research evidences point out that low socio-economic status assessed by 

 
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maternal standard of living is consistently associated with a higher prevalence of depression and 
other mental health related morbidities in cross sectional studies (Lorant et al., 2003).  
Moreover, women’s mental wellbeing is closely linked to many other core components such as: 
financial independence, family harmony, empowerment and self-efficacy. A number of studies 
have supported counseling as an intervention utilizing group approach for problem solving thus 
reducing depression and stress, thus fostering effective interpersonal skills.  Microfinance and cash 
transfer have proved to be a successful intervention in many developing countries, leading to 
increased household economic wellbeing, greater food security, increased children school 
attendance, gender equity, women empowerment, self-confidence, communication and reduction  
in the vulnerability of violence among women and their children (Paul, 2006 & Duvendack et al 
2011). Interventions in developing countries have shown effectiveness of life skills training for 
enhancing communication and assertive skills, decision-making, building self-esteem, self-
efficacy, reducing learning difficulties, decrease aggressive behavior, anger control, and changing 
attitudes towards engaging in sexual behavior (Ahmed, Petzold, Kabir, & Tomson, 2006; Naseri, 
A., & Babakhani; Maryam, Davoud, & Zahra, 2011). There is a dire need to empower women 
through programs such as cash transfer and LSB to reduce poverty, depression and violence.  
The research team involved in this study is building this proposal from the successful completion, 
and published randomized clinical trial with marginalized, impoverished women in Karachi, 
Pakistan where they tested the intervention of Economic Skills Building (ESB) for women 
(Karmaliani et al 2011, Karmaliani et al 2012). The training modules (Hirani et al., 2010) of the 
prior research included domains of communication, time management, conflict resolution, 
effective parenting, work life balance, dealing with violence, and personal grooming. The 
published results and positive health outcomes for Pakistani women suggest that women in ESB 
report significantly higher (p<0.05) for self-efficacy scores, as compared to counseling and control 
group women and more employment (Hirani et al., 2010). The results indicate that ESB is 
potentially effective intervention to improve maternal health and increase economic sufficiency. 
To date, little research has been done regarding women empowerment through cash transfer or 
micro-finance initiatives in Pakistan. Therefore, the current study is an attempt to evaluate the 
effect of these interventions in the context of Pakistan.  

 
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Micro-finance or Cash Transfer as an Intervention for Women’s Economic Empowerment 
The literature also supports that when CT or microfinance interventions are combined with 
educational programmes including health education, training on gender roles, and/or women’s 
empowerment, the outcomes are improvement in women and child health status, social status of 
women and financial betterment of a family (United Nations Population Fund and Microfinance 
Summit Campaign, 2006; Leatherman & Dunford, 2009). Moreover, it is found that anchoring 
microfinance programmes with social development interventions can assure effectiveness and 
sustainability of these programmes (Amin & Li, 1997). Similar kind of program, when evaluated 
for its impact in rural Bangladesh, revealed an improvement in children’s immunization rates and 
a decline in child mortality rates, among women who were part of the credit program versus their 
counterparts who were not (Ahmed, Petzold, Kabir, & Tomson, 2006).   
Additionally, Dy Khoy and Sieng (2005), sharing the example of a microfinance scheme 
developed during 2000 in Cambodia, stated that; its success is attributable to the fact that it was 
developed in collaboration with the Reproductive and Child Health Alliance (RACHA), which 
offered health education and health services. This microfinance/CT scheme resulted in an increase 
in community people’s ownership, knowledge on maternal and child health, and health seeking 
behavior.  
Thus, CT fills the gap in many developing countries, where cultural and social constraints limit 
opportunities for poor women. Improved health when CT is applied, offers promising results 
especially when it is implemented with LSB and women empowerment by involving men. 
Examples of positive health outcomes for women include: reproductive behavior, women’s 
empowerment, reduction in domestic violence as well as depression and anxiety, health literacy, 
maternal and child health, nutrition, and business success (Doyle et al., 2018). 
In a country like Pakistan, every woman lives in a web of relationships within her household. Her 
‘bargaining power’ within the household is to be found in her own resources and capital and her 
skills and relationships within her maternal family. Thus, her bargaining power within the 
household can draw upon relationships outside her home. Women’s actions for her health are 
determined by a number of factors, such as her own agency, and her relationships within the 
household and outside her household. The larger picture of a woman’s social milieu is important 

 
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to know in order to understand the impact from specific interventions, such as life skills 
development, and CT or micro-finance. 
To be able to provide the right intervention it is necessary that community is involved to share 
their problems and its solution. One of the known approaches is called Participatory Action 
Research (PAR). These strategies have been used in the field of health and violence against women 
for enhancing the reflection and analysis of participants. It can be used for any health issue 
provided the researcher believes the participants (i.e., couples) have the agency to take action on 
the basis of their reflection and analysis, and not on the basis of what is prescribed to them. 
The current research team was involved in a multi country study on women’s empowerment. 
Participatory Reflection and Analysis tools were used with groups of urban and rural women, 
whereby they reflected and analyzed women’s empowerment, health, mental health, and violence. 
Eleven Participatory Reflection and Analysis tools were used. In the mega project, Tawana, 
Participatory Reflection and Analysis was used to draw attention to malnutrition issues, and how 
malnutrition can best be addressed. Participatory Poverty Assessment for the planning commission 
of Pakistan used Participatory Reflection and Analysis tools for reflection and analysis of the 
livelihood of the poor and to identify the vulnerabilities of successful livelihood. A chapter was 
written for Pakistan Participatory Poverty Assessment about women’s mental health, which was 
written based on women’s perception of their mental health as they described it when Participatory 
Reflection and Analysis methods were used. Researchers of the LSB team are exceptionally 
prepared and experienced in Participatory Reflection and Analysis methods. 
Rationale 
A mother who is mentally ill is unable to provide support and care to her family and children. 
Similarly, men with low self-esteem cannot contribute to a healthy family bond. The purpose of 
this project is to enhance the self-worth of both mothers and fathers through the joint training of 
couples in the LSB 10-12 week program. The combination of LSB and BISP-CT has the potential 
of successful economic and health outcomes. Pakistan has major maternal/child health deficits 
where men in couple are largely absent from the picture and their involvement is neither given 
consideration nor has it been properly documented. Therefore, to empower women and achieve 

 
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gender equality is a global challenge requiring new and bold initiatives like the ones proposed 
by this study.  
Since men are frequently neglected in global health programs to improve maternal and child 
health, the BISP-CT plus LSB proposal for "couples" is an innovative strategy to test the 
involvement of men towards better maternal and child health. The extent of major maternal health 
deficits in Pakistan cannot be stressed enough; therefore, involving men is the new initiative 
which is being tested in this project. Previously mixed results were obtained in terms of reducing 
poverty and violence against women when BISP-CT & LSB were administered specifically to 
women only. Through the addition of men, the impact of LSB is proposed to be enhanced. 
Furthermore, the proposed study not only measures women empowerment alone but also couples’ 
empowerment through the interventions mentioned above. The purpose is to improve maternal 
and child health by empowering women through LSB training to BISP beneficiary married 
couples. 
Problem Statement 
Women in Pakistan are deprived of basic human rights of education, health and economic 
independence. Women remain dependent on their husbands, financially and socially.  
Studies conducted in other part of the world have supported CT and LSB to reduce poverty, 
depression and violence. Recently, the negative consequences of maternal depression on children 
have also been well documented. 
Situational Analysis 
The current situation of women in Pakistan due to financial dependence and poor life skills, as 
described above, makes the role of our research more imperative in combating this issue through 
innovative interventions. 
More specifically, the scope of this project is to improve maternal mental health by decreasing 
depression, empowering women economically and psychosocially so that they can prevent their 
victimization from violence and improve their health and family. Since children brought up in a 
healthy environment will grow up to build stronger families and hence the vicious cycle of 
continuing violence can be interrupted and stopped. 

 
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Therefore there is a need to test the interventions related to financial enhancement with LSB 
training to decrease maternal morbidity (depression), domestic violence, increase women financial 
empowerment, maternal and child health and nutrition. 
Hypothesis 
Introduction of LSB to BISP-CT beneficiaries in couples will reduce domestic violence and 
depression in married women of reproductive age by 20% and improve women empowerment by 
20%. 
Aim and Objective 
The aim of this research is in line with the 2030 agenda for Sustainable Development Goals. This 
agenda is a plan of action to strengthen universal peace and recognizes poverty as the greatest 
hurdle in sustainable development. The first goal of this document is concerned with a step of 
reducing poverty and the second goal aims to bring the efforts for gender equality by empowering 
women. Through BISP-CT intervention, it is hoped that the overall economic wellbeing of the 
women and their families will improve and through LSB, women will become more empowered. 
Ultimately they will be able to compete in the world as global citizen alongside men (Agenda for 
Sustainable Development, 2030). This study aims to engage men in women empowerment 
(MEWE) through LSB and BISP-CT to improve maternal mental health in Pakistan using a 
randomized control trial. 
Primary Objectives 
To measure the impact of men engagement in LSB and CT on maternal depression, domestic 
violence, improved self-efficacy and women empowerment. 
Secondary Objectives 
To measure the impact of men engagement in LSB and CT on Household food security, Gender 
Attitude, Economic Solvency and Resilience. 
Primary Outcomes  
Reduced maternal depression, domestic violence, improved self-efficacy and women 
empowerment. 

 
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Secondary Outcomes 
Improved household food security, gender attitude, economic solvency and resilience. 
Method 
Program Implementation and Approach 
The proposed study areas for the Formative Phase of the project are Punjab (Rahimyar Khan), 
Balochistan (Lasbela), Khyber Pukhtunkhuwa (Peshawar) and Sindh (Thatta). The cRCT will be 
conducted in district Thatta. 
Key Intervention 
The LSB modules’ training will be given to those who are receiving BISP-CT to perform their 
business and support their family. The intervention will consist of LSB training to BISP-CT 
beneficiaries for a period of 10-12 sessions for 2-3 hours per week in the selected arms. The LSB 
package will focus on the skills essential for Effective Communication, Understanding Roles of 
Men and Women, Understanding the Power Dynamics, Work Life Balance and Time 
Management, Conflict Management, Decision Making, Building Self Confidence, Dealing with 
Abuse and Harassment, Money Management and Income Generation. The modules will be offered 
by trained LSB teachers from the community to ensure sustainability and scalability. The LSB 
teachers will be trained by AKU researchers on pedagogy and delivery mechanisms, community 
mobilization and management skills along with monitory compensation as stipend. The LSB 
teachers will be offered refresher training 2-3 times on monthly basis for debriefing, expanded 
education, resource information and skill enhancement advocacy. 
These trained LSB teachers will teach the LSB module to a group of 10-15 married couples. 
Separate training sessions will be conducted for wives and husbands and similarly female LSB 
teachers will conduct sessions for wives and male LSB teachers will conduct for husband. These 
training sessions will be carried out simultaneously for both men and women. 
The quality and efficacy of training by LSB teachers for couples randomized to the LSB 
intervention will be cross-checked using process indicators, including number of sessions 
conducted, change of couple’s knowledge, increased in health seeking behaviors of couple along 
with additional measures of food security and family livelihood. 
Study Design  
This study will be conducted in two phases; (1) Formative Phase (2) cRCT. 

 
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Phase 1: Formative Phase (details available in separate section) 
This phase will take 1.5 years to execute the following activities 
1. Human Resource  
Identification, recruitment and training of Human Resource will be done. 
2. Planning Meeting with Stakeholders 
Meeting will be conducted with different stakeholders such as government official that 
includes BISP, community leaders etc. 
3. Qualitative Research through Participatory Reflection and Action (PRA) 
This strategy will be used at two points in time i.e. in the beginning of the study within the 
formative phase and after the completion of the cRCT intervention. The purpose is very 
specific at both ends:  
First end it will be utilized for culturally sensitive development of multiple tools such as, 
women empowerment, masculinity, and attitudes towards gender roles and module 
development for men. 
Second point of PRA is after cRCT where the purpose of PRA is to make research meaningful 
to the research participants. It will enable optimum opportunities for couples to share their 
thoughts, feelings and suggestions about the intervention and research processes. This will also 
enable research participants to reflect and analyze their experience of being part of this 
intervention.  
4. Development of Operational Plan for Interventional Design and Delivery Mechanism 
This will include; enrollment/recruitment point of BISP beneficiaries, mode of intervention 
delivery either group level i.e. males and females separately or couples together or individual 
couples, setting of intervention being delivered (facility or community), who will deliver the 
training (trained LSB teachers from the community), number of modules to be trained, number 
of districts/UCs/tehsil for interventional study, incentives for participants, definition and 
number of clusters required for randomization. 
5. Community Mobilization 
Additionally, community and district level systems assessment will be done to thoroughly 
assess; the geopolitical and sociocultural characteristics of the setting, the process of BISP-CT 
and feasibility of integrating LSB for married couples. 

 
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Phase 1: Formative Research 
The formative research will provide a rapid assessment of the local needs. This will guide the 
researchers to open a dialogue about how the families wish to empower women with the 
involvement of husbands. Together with community members, researchers can identify factors 
responsible not only for designing a locally tailored, culturally appropriate integrated 
intervention, but factors that help in sustainability and scale up of the intervention in long run. 
Objectives 
 To access and review the administrative structure and BISP beneficiary data from the selected 
districts for selection of eligible couples 
 To access the community in the selected districts to gain understating of the contextual factors 
that should guide the modification of proposed intervention (LSB with CT) 
 To identify and train human resource (trained LSB teachers from the community) for 
implementation of LSB module to eligible couples 
 To develop a national level LSB curriculum for men and women 
 To review the existing curriculums i.e. Rozan, Blue Veins, Men Engage, Sonke Justice, 
Promundo Pak-IMAGES 
 To develop tools for assessment of men engagement and gender roles 
 To explore the appropriate language for the translation of quantitative tools 
Theoretical Framework: Social Ecological Model 
In a country like Pakistan, every woman lives in a web of relationships within her household. Her 
‘bargaining power’ within the household is to be found in her own resources and capital and her 
skills and relationships within her maternal family. Thus, her bargaining power within the 
household can draw upon relationships outside her home. Women’s actions for her health are 
determined by a number of factors, such as her own agency, and her relationships within the 
household and outside her household. The larger picture of a woman’s social milieu is important 
to know in order to understand the impact of the proposed intervention.  
Therefore, in order to gain in-depth understanding of women’s status in local context we will use 
the Social-Ecological Model (SEM) in this formative research. SEM is theory based framework 
for understanding multifaceted effects of factors that determine a behavior. 

 
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According to this theory, the derivers of behavior i.e. violence, affecting women and child health 
outcome are found at every level of ecological model, within her family, community, 
neighborhood and society at large. These derivers can be best explained by using the SEM. 
Secondly, using this model, an appropriate intervention can be designed that can best address the 
impact of the behavior at all the four levels. 
The proposed intervention of LSB to women with the involvement of their husbands will help in 
decreasing domestic violence, maternal depression and increasing women empowerment. At 
individual and relationship level, the LSB training will lead to development of positive attitude for 
prevention of violence, effective communication between husband and wife, cash management for 
improved maternal and child health outcomes, mutual household decision making for family 
nutrition, health service utilization, better understanding of gender roles leading to improved status 
of women in the family. Similarly, at community and societal level, the LSB training to couples is 
anticipated to reduce social isolation of women by increasing women status or sensitizing the 
formal safety groups available within the community. Provision of environment where violence 
will be inhibited with the formation of resilient society.  

 
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Theoretical Framework: Social Ecological Model 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
F 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(Heise, 2016, 2011 & 1998; Carlson, 1984) 
 
 
 
kgjdffkgdfkgdkfgdfkgdfkgdf 
Society: 
Cultural norms, values and beliefs, 
acceptance of violence, sexism, 
and masculinity linked to 
aggression and dominance 
Community: 
Law enforcement practices, social 
services & mental health agencies, 
neighborhood characteristics and 
norms, inequitable distribution of 
societal resources 
Relationship: 
Family dynamics, quality of spousal 
relationship, gender roles and 
interaction patterns, disagreement 
and conflict, connectedness to kin 
and friends 
Individual: 
Attitude, values, skills, 
abilities, perceptions, 
weaknesses, habits, 
unemployment, marital 
problems, low self-esteem, 
family history 

 
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Study Site 
The formative phase of the study will be conducted for a period of 1.5 year in selected districts 
from four provinces of Pakistan: Sindh, Baluchistan, Punjab and Khyber Pukhtunkhuwa (KPK). 
The proposed districts are Thatta in Sindh, Rahimyar Khan in Punjab, Lasbella in Baluchistan and 
Peshawar in KPK. The purpose of conducting formative research in all provinces is to develop a 
National (Pakistan) level LSB curriculum for men and modification to the existing female 
curriculum. If there are not much differences in cultural context across the provinces and 
curriculum outcome is same, then the trial in Sindh is applicable for intervention in Pakistan and 
can be scaled up. The second phase of the project will be carried out in Thatta based on learnings 
from the formative phase.  
 
Sindh  
According to Multiple Indicator Cluster Survey (MICS) by UNICEF and Sindh Bureau of 
Statistics (2014), the total Fertility Rate in Sindh for the one year period before the survey was 4 

 
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children per woman. Almost 80% of ever married women receive antenatal care from a skilled 
provider. The prevalence of institutional deliveries is 64%. More than four out of ten children 
under the age of five in Sindh are underweight (42%) and 17% are classified as severely 
underweight. Almost half of children under five years (48 percent) are stunted or short for their 
age and one quarter (24%) children are severely stunted. 
Overall, 49% of women in Sindh feel that a husband is justified in hitting or beating his wife in at 
least one of the five situations i.e. when a wife neglects the children (36.5%), arguing with him 
(37%), going out without telling her husband (35.5%), wife refuses to have sex with the husband 
(30%) and about the same proportion reported if she burns the food, 34.5% if she does not perform 
household chores and 27.5% if she uses mobile phone, television or social media. 
Overall, 70.4% of women either watch television or read a newspaper or magazine or listen to the 
radio at least once a week which is a positive indicator for planners from the communication 
perspective. 
Punjab 
MICS by UNICEF and Bureau of Statistics, Planning and Development Department, Punjab 
(2014), found that the total fertility rate in Punjab for one year preceding the survey was 3.5. 
Almost one in three children under age five are moderately or severely underweight (34%) and 
11% are classified as severely underweight. 34% of children are moderately or severely stunted or 
too short for their age and 18% of children are moderately or severely wasted or too thin for their 
height. The results show that 17% of women do not receive antenatal care. Coverage of antenatal 
care by a skilled birth attendant is 79%, marginally higher in urban (89%) than rural areas (74%). 
The majority of the women receive antenatal care from medical doctors (67%) while the traditional 
birth attendants (TBAs) provide antenatal care to a small proportion of women (2%). 84% of live 
births, both the mothers and their newborns, receive a health check following birth within 2 days 
of birth, whereas for 9% of births neither mother nor newborn received it. 11% of women in Punjab 
read a newspaper or magazine, 5% listen to the radio, and 64% watch television at least once a 
week which is a positive indicator for planners from the communication perspective. 

 
Page | 20 
 
Overall, 40% of women age 15-49 years believe that a husband is justified in hitting or beating his 
wife for any one of five reasons that she; goes out without telling him (26%), neglects the children 
(27%), argues with him (26%), refuses sex with him (21%), and burns the food (15%).  
Baluchistan  
According to MICS by UNICEF and Planning and Development Department, Baluchistan (2011), 
the total fertility rate in Baluchistan is 4.2. 39% of the surveyed mothers received antenatal care 
from a skilled health provider (doctor, nurse or a midwife) at least once during their last pregnancy 
in two years. 63% of urban women received antenatal care from a health professional compared 
to 31% in rural areas. The survey showed that 35% women visited a doctor during their last 
pregnancy for checkups while 4% visited a Nurse/Lady Health Visitor/Midwife. However, 54% 
who gave birth in the two years before the survey did not receive any antenatal care. 
Overall, 62% women feel that a husband has the right to beat his wife for any of these reasons if 
she; go out without telling (42%), argues with him (39%), neglects the children (28%), refuses sex 
with him (21%) or burns food (22%). 
 
Khyber Pukhtunkhuwa (KPK) 
According to UNICEF and Planning and Development Department, NWFP. (2010), the total 
fertility rate in KPK is 5.16 children. 47% of women receiving antenatal care at least once during 
their pregnancy by any skilled personnel. Antenatal care coverage was 70% in urban areas, which 
is substantially higher than in rural areas (43%). 52% of women had not received any antenatal 
care and this rate was higher in rural areas, as expected. About 41% of births were delivered by 
skilled personnel compared to 28% in 2001. The proportion of institutional deliveries was 
approximately 39% with this happening more frequently in urban areas. One in three of the births 
(33%) were delivered with assistance from a medical doctor. The infant mortality rate was 
estimated at 76 per thousand live births, while the under-five mortality rate (U5MR) was 100 per 
thousand live births. The maternal mortality ratio was reported to be 275 per hundred thousand 
live births.  
More than half (52.17%) of females responded that a husband can beat his wife if she disobeys 
her, 26.09% responded that a husband can beat her wife is she does not take care of her husband, 

 
Page | 21 
 
21.4% responded that a husband can beat her wife s she goes out of the home without his 
permission, while 8.70% marked the option if wife visits to the male doctor without husband’s 
permission. 
Project Initiation 
The scope of formative research is wide, as it will be carried out across four provinces, therefore, 
for smooth functioning of project activities a good rapport building with the government 
stakeholders is one of the requirement. In order to establish rapport, meetings will be conducted 
with officials from BISP including; the Chairperson, Director General and BISP local 
representatives in the proposed sites. No Objection Certificate (NOC) from BISP Sindh will be 
obtained for timely initiation of project activities.  
For an in-depth understanding of local context, scope & network of BISP, access to administrative 
as well as BISP beneficiary data/documents will be required. For this purpose, a visit to proposed 
districts will be planned, starting from district Thatta in Sindh to achieve the following objectives.  
1. To verify the number of tehsils, union councils, approx. Deh within each district 
2. Identify missing union council’s information along with number of beneficiaries 
3. Identify stakeholders i.e. BISP beneficiary committees (BBCs), Non-Governmental 
Organization (NGOs), Universities, etc. 
4. To understand the geographical distribution and distance (similarities and dissimilarities, 
environmental factors, Socio-economic status (SES), education, occupations, etc.) 
5. To explore the extent of saturation of district Thatta with other projects and programs 
6. To meet at least one beneficiary and BBC mother leader for better understanding of 
context, family dynamics and willingness for innovation 
A thorough review of the data will be done (once received from BISP head quarter) by the 
research team for identification & selection of eligible field side locations (Tehsil/UC/Deh & 
clusters vs. control) and to locate the right participants (beneficiary couples) for the intervention 
to be carried out in phase II of project. Further, this data will help the research team for calculation 
of an appropriate sample size for the proposed intervention to be carried out in the next phase of 
project. To make this process more comprehensive, consultation from senior statisticians will also 
be done. 

 
Page | 22 
 
Qualitative Research through Participatory Reflection and Action (PRA) 
In order to design/plan the right intervention, it is necessary that community should participate to 
fully share their problems and solutions. One of the known approaches is called Participatory 
Reflection and Action (PRA). It can be used for any health issue provided the researcher believes 
the participants (i.e., couples) have the agency to take action on the basis of their reflection and 
analysis, and not on the basis of what is prescribed to them. The purpose of using PRA for 
qualitative research during the formative phase is very specific i.e. it will guide the team to gain 
an in-depth understanding of:   
 Existing status of the women in the large picture of family dynamics 
 Couples perception of role of men in women empowerment and family harmony   
 Existing maternal & child health related issues and their solutions in order to design 
and develop an appropriate intervention for couples  
 Identify factors which would help in sustainability and scale up of proposed 
intervention in the long run 
 Review of the existing literature for the development of:  
o Tools for masculinity, economic solvency, gender roles, etc.  
o LSB curriculum for women and men 
 Modification of existing measurement tools 
This qualitative research will be done by conducting Focus Group Discussions (FGDs) and Key 
Informant Interviews (KIIs) in the selected districts. A total of 10 FGDs and 10 KIIs will be 
conducted in each district. The details are given in Table 1 and 2. 
Table 1: Total Number of KIIs by Study Site 
  
Sindh 
Punjab 
Baluchistan 
KPK 
Total 
KIIs (Male)  
5 
2 
2 
1 
10 
KIIs (Female) 
2 
- 
- 
2 
4 
Total  
7 
2 
2 
3 
14 
 
Table 2: Total number of FGDs by Study site 
 
Sindh 
Punjab 
Baluchistan 
KPK 
Total 
FGDs (Male)  
3 
2 
2 
2 
9 
FGDs (Female)  
3 
2 
2 
2 
9 
Total 
6 
4 
4 
4 
18 

 
Page | 23 
 
 
Participants Recruitment and Sampling 
The participants for the FGDs and KIIs will be identified and recruited purposively through the 
BISP district network. The participants for FGDs will include BISP-CT beneficiary couples or 
couples belonging to similar socio-economic status from other provinces. For KIIs, BISP 
Beneficiary Committee (BBC) members and provincial/district BISP representatives from local 
BISP district network, social mobilizers, community workers and health care professionals were 
also included have also participated for KIIs. Two separate teams comprised of one moderator and 
one note taker will be assigned in each study district for conducting FGDs with males and females. 
Data Collection 
As explained above, the data collection will be carried out through FGDs and KIIs. The FGDs will 
be conducted with the group of participants consisting of 10-15 people and the duration of each 
FGD will be 60 to 90 minutes. The FGD participants will be a homogenous group with respect to 
age, gender, socio-economic status, etc. Each KII will be conducted for the duration of 30 to 45 
minutes. Separate interview guides will be developed for FGDs and KIIs with predefined domains 
including understanding about gender roles, concept of masculinity, violence and women 
empowerment. The interview guides will be developed by reviewing the available literature and 
mutual consultation with experts within the team. All the interviews will be tape recorded after 
taking informant consent from the participants. The data collection will continue till the level of 
saturation is achieved. All the interviews and discussions will be conducted in the local language, 
convenient to the participants. 
Data Management 
Transcription and Translation 
A thorough meeting will be conducted at the end of every interview and discussion sessions. The 
audio tapes and field notes will be properly labeled with the date, time, name of the group and 
participants. The moderator and the note taker will examine all the field notes. After the discussion, 
further probes and additional questions may be added to the interview guide for next interview or 
discussion, if required. All the recorded interviews will be transcribed to Sindhi/Urdu followed by 

 
Page | 24 
 
translation to English language. After the translation, the moderator and translator will check the 
translated script against the recorded tapes for accuracy and consistency. 
Data Analysis 
Analysis of the qualitative data will be conducted using Braun and Clark’s thematic analysis 
(Braun & Clarke, 2006). The researchers will begin by familiarizing with the data, generating 
codes, searching, reviewing and naming themes. Relevant categories will be picked from the 
transcribed data and linked to the different themes. All disagreements will be discussed and 
consensus will be reached on the overall analysis. All the transcripts will be reviewed again in the 
end to make sure that the necessary information had been captured. 
Phase 2: Cluster Randomized Control Trial 
In the second phase, a Cluster Randomized Control Trial will be performed for 2 years.  
Inclusion and Exclusion Criteria 
The couples will be recruited from the list of women who are receiving BISP-CT and meet the 
eligibility criteria of: adult married women who: receive BISP-CT, have one child of at least 18 
months and have no family migration plan for next 2 years. 
The couple in which either of the partners has gross mental impairment, physically challenged or 
bedridden, will be excluded. 
Sample Size 
There will be three groups for cRCT. The first group will receive LSB to BISP-CT beneficiaries 
and their husbands. The second group will receive LSB only to women receiving BISP-CT. The 
third group will be the control arm who will receive BISP-CT only. Assuming an average cluster 
size of at least 25 couples, with the baseline prevalence of depression 60% and expected reduction 
of 20% in intervention arm, 9 clusters per arm would be needed over a period of two years. There 
are three arms and 9 clusters in each arm so a total of 675 couples (225 in each arm, 25 in each 
cluster). By accounting for the attrition rate of 25%, a minimal of 846 couples (282 per arm) would 
be needed. 

 
Page | 25 
 
Sampling Strategy 
During the first level of assessment, out of the four Tehsils in District Thatta, Tehsil Mirpur Sakro 
will be finalized for the intervention, since Tehsil Thatta is saturated with other NGOs/Projects, 
Tehsil Ghorabari and Tehsil Keti Bunder are difficult to manage administratively, being far away 
and coastal areas. At the second level of assessment in Tehsil Mirpur Sakro, the UCs will be 
assessed based on the demographic characteristics, infrastructure, health facilities, accessibility 
and women mobility. The UCs being administratively hard to reach i.e. lack proper infrastructure 
(roads), saturated with other projects, being close to city with urban settlements, will be excluded. 
Three UCs i.e. Gharo, Gujjo and Chowbandi will be identified as the potential sites for the 
intervention. Within the UCs, Deh/Village is the smallest unit, but since there is no clear 
demarcation between Dehs, therefore village or a group of small villages will be considered as a 
cluster. The clusters will be created by grouping small villages with respect to geographic 
boundaries, ethnic cast and number of households. Each cluster will have sufficient number of 
households to achieve the targeted cluster size. The large geographically separated villages will be 
considered independent clusters. The mapping of clusters will be done in a way to maximally avoid 
contamination. A minimum of 27 clusters will be selected randomly from a sufficient pool of 
clusters i.e. 9 from each arm keeping same number of clusters per arm in each UC. At the third 
level of assessment, the clusters of the selected UCs will be randomly assigned to three arms. The 
clusters will be selected for randomization based on the assumptions, i.e. having sufficient number 
of BISP beneficiary households meeting our eligibility criteria, the intervention and control 
clusters will not be in close proximity thus chances of contamination are minimal. 
Operational Plan 
The implementation of the manualized LSB curriculum will be delivered through 10-12 sessions 
(10 for couples, 2 for family including mother-in-law, supporter or head of the household), one 
session per week for each cohort of 282 couples. Therefore, for three cohorts, a total of 846 
couples, will require nine months. There will be 12 LSB teachers (8 females, 4 males) working in 
six pairs for six groups (4 women, 2 men) for the entire year. The purpose is to ensure high quality 
staff, optimum delivery of the intervention between the cohorts, and proper fidelity monitoring. 
Regarding the data collection plan, the data collection points are pre-intervention (baseline) and 
post-intervention (end-line, five months). The schematic illustration is mentioned below in figure 
4. 

 
Page | 26 
 
Safety protocols amid COVID 19 
Capacity building of the research team will be carried out, where a comprehensive COVID-19 
awareness training will be offered to the field team. The field preparations will include; adequate 
supply and use of PPEs (face masks, sanitizers), information communication material (in local 
language) to be used in field office and community settings. Furthermore, the team will work 
closely with the DC office Thatta to obtain the list of nearby health facilities assigned by the 
provincial government to provide COVID-19 screening, testing, isolation/quarantine, 
treatment/referral in the study area. This exercise will ensure the safety and wellbeing of staff and 
community participants, before the actual delivery of LSB intervention in the study area. 
Moreover, to ensure the wellness of field staff, an orientation regarding the use of CoronaCheck; 
a new mobile app that enables them to easily and safely evaluate symptoms with an in-home 
screening tool and understand the next steps they need to take to look after themselves, will be 
provided. The app allows the staff to understand their symptoms, identify whether they may have 
contracted COVID-19 and seek help in a timely manner. It also helps the staff to identify potential 
coronavirus carriers and limit their risk of transmission. It will be assured that, the staff should use 
the app on daily basis as they come to office and contact AKU employee health service for initial 
screening and if needed testing.  
In community, the participants will be provided awareness sessions on novel corona virus and 
measure to keep the surroundings safe and healthy. Furthermore, they will be provided PPEs (face 
masks and sanitizers).  In order to maintain the safety and wellness of both LSB teachers and 
participants, social distancing and frequent hand washing will be ensured during each session. 
Large groups sessions will be avoided and the number of participants will be restricted between 5-
6 per session. Two sessions per day will be conducted instead of one by each pair of LSB teacher, 
to train 10-12 participants as per the plan of delivery.  
 
 
 
 

 
Page | 27 
 
Figure 4. Schematic illustration 
 
Process Outcome Measures 
Outcome measures for men and women receiving LSB training are the same. Process indicators 
include number of couples trained, number of sessions attended by couples, and number of follow-
up assessments completed. 
Data Management 
Pre-testing 
The translated versions of the questionnaires will be pre-tested by being administered to 
approximately 10% of the sample size in a district similar to the selected district. The completed 
questionnaires will be sent for data entry so that the psychometric properties of the scales will be 
checked. Any difficulties in translation, comprehension or item performance will be resolved by 
team discussion after this and final changes made to the questionnaire. 
Tracking Participants 
The study dataset will be a closed cohort and so it is important to track participants to determine 
cause of any loss to follow up and also to be able to connect interviews completed at different 
rounds. In order to do this we will complete an enrolment form for each couple in the study. These 
will be completed on paper and will be stored under lock and key at Aga Khan University. Each 
tracking form will include a randomly generated 6 digit number which will be that couple’s 

 
Page | 28 
 
research ID and initials. In electronic data the couples will only be identified by research ID and 
initials which cannot be electronically linked to their name. 
The tracking form will include the following information: 
• 
Allocated ID 
• 
Name 
• 
Union Council, Tehsil, District  
• 
Address  
• 
Contact numbers 
• 
CNIC numbers of couple 
Assessment Tools 
The outcomes will be assessed through validated instruments including Patient Health 
Questionnaire (PHQ-9), The Revised Conflict Tactics Scale, General Self-Efficacy Scale, 
Resilience Scale, Economic Solvency, Gender Equitable Attitude Scale and Six-item Food 
Security Questionnaire. Pilot testing will be done followed by modifications in the tools, if and 
where required. 
Demography 
Demographic profile will be used to assess the overall information about the family, its economic 
and educational status. This form was designed and utilized in the Global Network Research Unit 
(GNRU) project on perinatal infections and pregnancy outcomes which was funded by National 
Institute of Health (NIH), with AKU and University of Alabama as partners and other AKU funded 
researches (Karamaliani et al., 2009). This demographic profile form includes two sections: 
Section A:  Demographic profile: age, education, language, number of family members, number 
of married or unmarried and previous pregnancies and number of children. 
Section B: Socio-economic Status: number of people actively working including type of work, 
timings and utilization, type of living with accessories and water drinking. 
Section C: Economic Solvency: Financial assistance received other than BISP, financial 
assistance received for child support and cash assistance received from other people. 

 
Page | 29 
 
General Self-Efficacy Scale (GSE-10) 
This 10-item instrument was created to assess a general sense of perceived self-efficacy with the 
aim to predict coping and adaptation after stressful life events (Schwarzer, 1995). 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. The possible range of scores is 10 to 40. In samples from 23 countries, Cronbach’s 
alphas ranged from 0.76 to 0.90, with the majority in the high 0.80s. For the GSE, the total score 
ranges between 10 and 40, with a higher score indicating more self-efficacy (Schwarzer, 1995). 
For this study, the Urdu adaptation of the GSE tool, developed by Tabassum, Rehman, Schwarzer, 
and Jerusalem was used (Tabassum et al., 2003). 
The Revised Conflict Tactics Scale (CTS2S-20) 
The revised conflict tactics scale 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 (Douglas & Straus, 2004). 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). For this study, Sindhi translated version will be used after pre-testing. 
Patient Health Questionnaire (PHQ-9) 
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). It is used to monitor the severity of depression and 
response to treatment. It can be used to make a tentative diagnosis of depression in at-risk 
population (Kroenke, Spitzer, & Williams, (2001). For this study, the Urdu adaptation of the PHQ-
9 tool will be used (Ahmad et al., 2018). This tool has been translated into Sindhi language and 
will be used in this study. PHQ-9 total score for the nine items ranges from 0 to 27. Scores of 5, 

 
Page | 30 
 
10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression, 
respectively. 
The Resilience Scale (RS-14) 
We will use Wagnild’s resilience scale for our study. This tool has been validated in Urdu in 
Pakistani context. This resilience scale comprised of five core characteristics of resilience that 
include: purposeful life, perseverance, equanimity, self-reliance and existential loneliness. It 
comprised of validated 14 items with 7-point Likert scale to rate the individual’s evaluation 
ranging from 1 (Strongly Disagree) to 7 (Strongly Agree) (Shehzad et al. 2015). 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). 
Gender Equitable Attitude Scale (GEAS-21) 
The Gender Equitable Attitude Scale is a 21 item scale with 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. This scale has been tested by Pak-IMAGES study by Promundo and Men’s 
HUMQADAM program by Rozan (Ashfaq et al., 2018). Factor analyses support two subscales, 
and the scale is internally consistent (alpha = .81) (Pulerwitz & Barker, 2008). The total score 
ranges from 21-84, where higher score shows more gender equitable attitudes. 
Six-item Food Security Questionnaire (FSQ-6) 
A six-item food security questionnaire (FSQ) will be used to assess the food insecurity. The scale 
is valid, reliable and sensitive screening tool of food insecurity in people. One study had found 
that a strong correlation between the two-item and six-item FSQ (ρ: 0.895; 95% CI 0.821, 0.940; 
P, 0<0001). Cranach’s a coefficient was found to be 0.94 and 0.90 for the two-item and six-item 
FSQ, respectively. FSQ yielded a sensitivity of 100% (95% CI 75, 100) and a specificity of 78% 
(95% CI 61, 90). The negative predictive value was found to be 100% (95% CI 88, 100) (Young, 
et.al 2009). 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. 

 
Page | 31 
 
Data Analysis 
To avoid possible human error of missed or incorrect entries, the entered data will be cross checked 
initially by data coordinator, and discussed with research team and principal investigators, if 
required. All the data will be double entered in Excel, followed by congruence check and cleaning. 
It will be imported to STATA version 12.1 for the analysis, after cleaning. 
Descriptive Statistics: Descriptive statistical analysis will be run to look at the distribution of 
variables of interest and for outcome variables. Mean and standard deviation will be calculated for 
continuous variables, proportions will be calculated for the categorical variables.  
Logistic regression will be used to assess the effect of LSB with maternal depression and other 
outcomes. All variables meeting the criteria will be used for building the final model. The variable 
found most significant in the univariate analysis will be subsequently added first and the next 
significant variable one after the other. Variables found statistically non-significant (>0.05), 
biologically not meaningful will be removed from the model. Multivariate logistic regression will 
be carried out to reach to the most parsimonious model. 
Communication Plan and Stakeholder Management 
The project team will involve stakeholders at multiple levels. At national, coordination with BISP 
office in Islamabad and other relevant programs on maternal and child health will be carried out 
to sensitize them about the study scope and the outcomes and their implications on policy.  Study 
team will meet regularly in coordination with Umeed-e-Nau program management over the study 
period and will discuss the project implementation.  
Local stakeholders will include the BISP offices in Sindh province. Regular coordination is needed 
with the provincial office Local Health Department in the study will also be presented the results. 
Biannual meetings will be set with local stakeholders to share research progress and milestones. 
Monitoring and Evaluation Plan 
The primary responsibility for monitoring the fidelity of the intervention delivery will rest with 
Aga Khan University and they will be required to ensure that a log sheet is kept recording the 
trainings conducted by faculty of AKU to train LSB teachers and number of couples who attended 
the training. This information will be reported quarterly to Principal Investigators. The information 

 
Page | 32 
 
will be compared to the planned intervention delivery schedule and deviations will be flagged and 
fed back to the project management team.  
The research team will have responsibility for spot checks on the fidelity logs and field visits to 
ensure accurate, timely and smooth data collection and the LSB intervention delivery. The field 
coordinators will visit each intervention site independently for the monitoring of data collection 
and LSB intervention. 
Project Management Structure and Organization 
The overall responsibility for the study is on PI, component lead and co-lead and Co-PIs from the 
Aga Khan University School of Nursing and Midwifery, Psychiatry and Community Health 
Sciences department and they will have final scientific responsibility for the study including the 
research conduct, reporting of main outcomes, stakeholder relations and dissemination of findings. 
They will be supported in this role by technical advisor Professor Judith McFarlane of Texas 
Woman University. The project is multidisciplinary and will draw on expertise from a range of 
faculty members from other disciplines at Aga Khan University.  
Technical and Financial Reporting 
This team will report technically and financially to PI and Co-PI of Umeed-e-Nau (UeN) at COE-
WCH, AKU and the funding agency. 
Ethical Considerations 
Ethical approval will be obtained for the present study from Ethics Review Committee (ERC) of 
Aga Khan University (AKU) Karachi. Permission for data collection will be taken from the 
concerned stakeholders. Study related material will be explained verbally and a brief description 
of study will also be provided in the consent form. It is also clearly explained in the consent form 
that there is no benefits or potential risk attached with the study. Furthermore, the members were 
given the right to withdraw at any stage of the study. Keeping in view the comfort level of 
participants the qualitative data collection (FGDs & KIIs) will be carried out in local languages. 
For Sindh the guides will be used in Sindhi language while for Khyber Pakhtunkhwa (KPK) the 
guides will be used and facilitated in Pashtu language. However, participants from Rahim Yar 
Khan and Labella will mainly be facilitated using Urdu version of interview guides will be used.       

 
Page | 33 
 
During the data collection and analysis time the data will be stored in lock and key and only PI 
and designated study members will have access to it. Confidentiality and anonymity of the 
participants will be maintained during the entire process of the study. However, direct access will 
be provided to regulatory bodies for monitoring and audit purpose. 
Not a single participant will be enrolled in the study until the trial is registered with the Clinical 
Trail Unit (CTU). The process of trial registration will be initiated once the pre-testing of 
assessment tools has been completed.  
 
 
 
 
 

 
Page | 34 
 
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