Background
The American Psychological Association has defined trauma as an ‘emotional response to a terrible event such as an accident, natural disaster or rape etc’ (APA, 2016). Exposure to trauma leads to post-traumatic stress disorder (PTSD) (Stein et al., Reference Stein, Karam, Shahly, Hill, King, Petukhova, Atwoli, Bromet, Florescu and Haro2016). Low and middle-income countries (LMICs) have higher trauma exposure, with high rates of PTSD in post-conflict areas (Atwoli et al., Reference Atwoli, Stein, Koenen and McLaughlin2015). Post-trauma symptoms can particularly overburden parents and cause withdrawal and conflict among family members (Harrison et al., Reference Harrison, Albanese and Berman2014). It has been reported that trauma may be transmitted to offspring via parenting practices burdened with severe parental emotional distress (Song et al., Reference Song, Tol and De Jong2014). Hence, trauma and PTSD in parents leads to increased risk for mental and physical illnesses in children (Creech and Misca, Reference Creech and Misca2017; Palosaari et al., Reference Palosaari, Punamäki, Qouta and Diab2013), behavioural issues along with trauma-related symptoms (Creech and Misca, Reference Creech and Misca2017), disturbed parent–child relationships such as child abuse (Cross et al., Reference Cross, Vance, Kim, Ruchard, Fox, Jovanovic and Bradley2018; Montgomery et al., Reference Montgomery, Just-Østergaard and Jervelund2019), and high incidence and intergenerational spread of family violence (Olema et al., Reference Olema, Catani, Ertl, Saile and Neuner2014; Timshel et al., Reference Timshel, Montgomery and Dalgaard2017).
The prevalence of PTSD in Pakistan both due to natural disasters and on-going conflict is high (Khan et al., Reference Khan, Amatya, Gosney, Rathore and Burkle2015). In a survey study (N = 500) in Islamabad in Pakistan, it was found that 20.2% people reported that they experienced direct trauma during the last 12 months (Naeem et al., Reference Naeem, Taj, Khan and Ayub2012). Additionally, nearly half of those (45.3%) who directly experienced trauma in addition to an indirect exposure scored positive for PTSD, compared with one-fifth (20.8%) of those who only experienced indirect trauma (Naeem et al., 2012). Pakistan has been in constant turmoil for decades; the threat level varies from city to city and locality to locality. The incident on the 16th December (2014) at the Army Public School (APS) in Peshawar, Khyber Pakhtunkhwa (KPK) province, which involved the shooting of young children, teachers and other staff in addition to an attack a year later at Bacha Khan University (in KPK) in January 2016, have had a major impact locally, nationally and internationally. A further terrorist attack on students at Peshawar University on 1st December 2017 again left the whole country in a state of shock and emotional turmoil. There is evidence that such events affect even those who hear about them but certain groups, such as the parents of school-going children are most affected (Khalily, Reference Khalily2011).
A healthy and positive development is consistent with positive,nurturing and secure parent-child attachment, family-community, and community-society relationships that reinforce self-worth, minimise frustration, and promote self-confidence (Winston and Chicot, Reference Winston and Chicot2016). Positive and nurturing parent-child relationships are largely dependent upon parents' ability to offer a secure and consistent environment for their children. It is reported that parental involvement, in the form of family routines, parental monitoring and supportiveness, is a protective factor for children facing conflict and disruption (Dubow et al., Reference Dubow, Huesmann, Boxer, Landau, Dvir, Shikaki and Ginges2012).
The impact of early parenting interventions on parents and infants has been reviewed and meta-analysis reported that parenting interventions are effective in improving parenting responsiveness (d = 0.77) (Mihelic et al., Reference Mihelic, Morawska and Filus2017). An integrated intervention called learning through play plus cognitive behaviour therapy (LTP Plus TF-CBT) has found to be effective in low resource settings such as Pakistan (Rahman et al., Reference Rahman, Iqbal, Roberts and Husain2009; Husain et al., Reference Husain, Chaudhry, Furber, Fayyaz, Kiran, Lunat, Ur Rahman, Farhan and Fatima2017a, Reference Husain, Kiran, Shah, Rahman, Saeed, Naeem, Bassett, Husain, Ul Haq and Jaffery2020). The LTP aims to stimulate early child development and its central feature is a pictorial calendar devised for parents, depicting eight successive stages of child development from birth to 3 years (Centre, 2002). Evidence also exist on parenting interventions delivered in the face of conflict and displacement in Syria (El-Khani et al., Reference El-Khani, Cartwright, Redmond and Calam2016).
Primary findings indicate that caregivers who have difficulties managing their own stress in addition to the stress caused by the child's behavioural and emotional changes require support maintaining positive parenting strategies. Trauma-focused cognitive behaviour therapies (TF-CBTs) are defined as interventions that include a systematic focus on processing trauma memories (Ennis et al., Reference Ennis, Shorer, Shoval-Zuckerman, Freedman, Monson and Dekel2020) and can be a potential intervention for trauma survivor parents. Trauma-focused cognitive-behavioural therapy has proven very helpful and is often the treatments of choice for individuals with PTSD (Watkins et al., Reference Watkins, Sprang and Rothbaum2018). However, implementation of trauma-focused interventions is hindered in LMICs because of limited access to evidence-based psychological treatments and socio-political instability (Chen et al., Reference Chen, Olin, Stirman and Kaysen2017).
We propose to investigate the acceptability, feasibility and preliminary effectiveness of a manual assisted learning through play (LTP) plus culturally adapted TF-CBT among parents with young children experiencing PTSD. LTP Plus is proposed as a low-cost intervention to improve parents' mental and physical health and promote healthy child development. The activities in LTP are meant to enhance the social and emotional development of children. The activities are designed in a way which requires parents to be sensitive to the children's needs and actively engage with them, thus strengthening attachment (Husain et al., Reference Husain, Zulqernain, Carter, Chaudhry, Fatima, Kiran, Chaudhry, Naeem, Jafri and Lunat2017b, Reference Husain, Kiran, Shah, Rahman, Saeed, Naeem, Bassett, Husain, Ul Haq and Jaffery2020). In the proposed study LTP will be integrated with adapted trauma-focused CBT (Naeem et al., Reference Naeem, Phiri, Munshi, Rathod, Ayub, Gobbi and Kingdon2015; Latif et al., Reference Latif, Husain, Gul, Naz, Irfan, Aslam, Awan, Sharif, Rathod and Farooq2020) and will be delivered in a group format. TF CBT delivered in group settings uses cognitive restructuring techniques to facilitate each group member in processing their trauma experience. Each participant in a group has the opportunity to narrate his or her personal story as other group members listen. Hence, there is potential for all group members to participate in trauma processing through both recounting their own traumatic experience as well as vicarious experiences of others'. TF CBT group models encourage: strength of the personal narrative, power of group support, members ‘stand together’ and hear the experiences of others without judgment (Foy, Eriksson, and Trice, Reference Foy, Eriksson and Trice2001).
Research question
Whether the LTP Plus TF CBT is more feasible, acceptable and potentially effective as compared to the routine care for parents of young children in Pakistan?
Hypothesis
The LTP Plus TF CBT will be more feasible, acceptable and potentially effective as compared to the routine care for parents of young children in Pakistan.
Method
Design
This is a two-arm pilot cluster RCT. Both qualitative and quantitative assessments will be administered to all eligible participants at baseline and after 4 months (end of the intervention).
Randomisation
Randomisation will be computer-generated by an off-site statistician. The unit of a cluster will be Union Councils. A union council forms the second-tier of local government and fifth administrative division in Pakistan, The Union Councils will be randomly allocated to one of the two arms; arm-1 is the intervention group receiving LTP Plus and TF-CBT whereas Arm-2 is routine care.
Blinding
The proposed study will be a single-blind study. The outcome assessors will be blind to the allocation status.
Study site and population
Participants will be recruited from community settings (e.g. primary care) in Peshawar and Karachi with the assistance of community health workers (CHWs). Karachi is the capital of the province of Sindh, and the largest city in Pakistan, the world's third most populated city (Karachi Metropolitan Corporation). Karachi is a metropolitan city with diverse populations of political and economic migrants, refugees from different religious, linguistic, provincial and national origins who move to settle permanently. Peshawar is the capital of the province KPK, situated close to the border of Afghanistan. It has gone through major changes as a result of the Soviet-Afghan war and ongoing conflicts.
The parents with children aged between 3 and 6 years old will be screened with the Impact of Event Scale-Revised (IES-R) 22-item scale (Sundin and Horowitz, Reference Sundin and Horowitz2002). Those scoring 24 or above will be eligible for a full assessment of PTSD measured by Clinician-Administered PTSD Scale-5 (CAPS-5). The IES-R has been successfully used in Pakistan (Latif et al., Reference Latif, Husain, Gul, Naz, Irfan, Aslam, Awan, Sharif, Rathod and Farooq2020).
Inclusion criteria
• Parents over the age of 16 years
• Living with their children age 3–6 years
• Who meet the criteria for CAPS-5
• Able to give informed consent
Exclusion criteria
• Parents with diagnosed severe physical or learning disability or severe mental illness which prevents them from attending the LTP Plus group intervention. This will be assessed by the research team at the screening stage. Any disabilities will be identified by a relevant clinician (e.g. Psychiatrist).
• Those who expressed active suicidal ideation during screening.
• Current use of anti-depressant medication reported by the parents.
Procedure
Trained CHWs will approach potential participants in community settings (e.g. primary care, basic health units) in both intervention and control clusters. CHWs will assess potential participants against eligibility criteria (accept the diagnosis of PTSD using CASP). All potentially eligible participants will be invited for a meeting with a trained researcher who will then administer CASP on otherwise eligible participants. After screening, a detailed Participant Information Leaflet (PIL) will be provided to eligible parents and written (thumb impression for participants who are unable to read and write) consent will be obtained. Trained researchers will complete baseline assessment with all consented participants. Participants in the intervention cluster will receive 12 group sessions of LTP Plus TF CBT over the period of 4 months. A follow-up assessment will be done with all the participants 4 months after baseline.
Intervention
Learning through play + trauma-focused cognitive behaviour therapy (LTP + TFCBT)
The culturally adapted parent-focused group intervention (LTP plus TF-CBT) will be delivered to parents by masters-level trained psychologists supported by CHWs weekly during the first 2 months and then fortnightly at schools either at school drop-off or pick-up time depending on participant's preference and other community settings. The parenting component of the intervention (LTP) will be led by the CHWs and psychologists will lead the TF CBT component of the intervention. We have published a large cluster RCT of integrated parenting intervention called LTP Plus CBT for depressed mothers where CHWs successfully delivered intervention facilitated by the psychologists (Husain et al., Reference Husain, Kiran, Fatima, Chaudhry, Husain, Shah, Bassett, Cohen, Jafri and Naeem2021). The Intervention will be delivered in 12 sessions of 60–90 min in addition to routine care. The LTP plus TF-CBT has two components;
1. Culturally adapted learning through play (LTP)
2. Culturally adapted trauma-focused cognitive behaviour therapy (TF-CBT)
LTP aims to enable parents to improve their child's psychical and psychosocial development by educating about child development and the importance of parent-child play. The pictorial calendar, which starts from birth and exhibits eight stages of healthy child development until 6 years of age, is an important feature of LTP. To enable a better understanding of how learning and attachment works, the calendar comes with culturally adapted illustrations of parent-child play (Husain et al., Reference Husain, Kiran, Shah, Rahman, Saeed, Naeem, Bassett, Husain, Ul Haq and Jaffery2020).
Component 2 of this integrated group intervention involves a culturally adapted manual-assisted cognitive behaviour therapy (CBT) for PTSD, based on the cognitive model by Ehlers and colleagues (Ehlers et al., Reference Ehlers, Clark, Hackmann, McManus and Fennell2005). The cognitive appraisals, memory characteristics and behavioural strategies which maintain PTSD are all considered while developing this model. The aim is to encourage careful questioning to modify negative appraisals of the trauma. The culturally adapted manual BASID (Baad Az Sadma Zehni Dabao) Ki Kahani – The Story of Basid (Latif et al., Reference Latif, Husain, Gul, Naz, Irfan, Aslam, Awan, Sharif, Rathod and Farooq2020), consists of nine chapters and in addition to psycho-education and culturally sensitive advice on improving relationships, it includes practical exercises on; dealing with avoidance, behavioural activation, problem-solving and dealing with unhelpful ways of thinking through thought restructuring. The manual uses culturally sensitive idioms of distress, stories, and expressions. For example, the principle of exposure is explained through Aesops' famous fable about a lion who fears a lion in the water when he tried to drink water from a pond. It is only when he jumps over the lion that the lion disappears. The manual describes stories of three persons who have experienced trauma, and how they managed their traumatic stress.
Chapters of BASID are woven throughout the intervention curriculum, as evidenced from table 3, each session contains some content from LTP and some part from BASID. The first part of the session (approximately 30–40 min) is focused on LTP and the second part (approximately 40–50 min) is dedicated to parents' mental health using BASID chapters. Three stories (Mr Rasheed, Ms Nasreen Bibi and Mr Muhammad Sabir) are referred to throughout the different sections of BASID such as how Muhamad Sabir prepared a list of graded exposure (session 5), how Muhammad Sabir identified his problems in problem-solving session (session 8), Nasreen Bibi's thought diary and thought challenging in session 9 and 10, Rasheed's example in session 12 on staying healthy (Table 1).
Table 1. LTP Plus TF CBT Intervention schedules
Research assistant (RA) training and inter-rater reliability
Training sessions for assessment measures are conducted for the RAs in Pakistan by senior trained professionals (NH, ZZ, FN, NC). To ensure consistency, local principal investigators (PIs) will measure the inter-rater reliability throughout the study. Moreover, those who deliver the intervention will attend a 3-day training on LTP Plus TF CBT by master trainers. These training sessions will involve a structured presentation on each session from the manual followed by a role play and discussion. These interventionists will be regularly supervised by the master trainers (AQ, ZZ, TK). These supervision sessions will be held on a fortnightly basis and include role play, case presentations and discussions.
For assessment of fidelity, we will use the participant observation method that we have already used in our published cluster RCT (Husain et al., Reference Husain, Kiran, Fatima, Chaudhry, Husain, Shah, Bassett, Cohen, Jafri and Naeem2021). On each study site (Peshawar and Karachi) two senior raters expert in LTP plus TF CBT will attend the sessions as delegates. Raters will develop and use a specific observation checklist which will be comprised of different domains from each age range of LTP and from each area of development from five areas identified in the LTP manual, as well as core components of TF CBT. The two raters will independently rate each session. Scores on the observation checklist will be reviewed for assessment of fidelity. In order to ensure consistency, the same two raters on each site will complete the fidelity assessments.
Treatment as usual (TAU)
The TAU group will receive routine treatment which may consist of support from general practitioners. The TAU also includes routine care provided by the CHWs (called Lady Health Workers in Pakistan). The CHWs are responsible for maternal, neonatal and child health in Pakistan and also take care of immunisation and family planning. Each CHW is responsible for approximately 150 households and they visit each household once a month (visiting 5–7 homes daily). They are also trained in interpersonal communication and community engagement.
All the participants in the TAU group will also receive detailed baseline and follow up assessment visits.
Ethical considerations
Full ethical approval has been obtained from the ethics committee of the Institute of Professional Psychology (IPP), Bahria University Karachi, Pakistan. The research team will fully comply with the International Conference on Harmonisation Good Clinical Practice (ICH-GCP) guidelines.
Data protection and confidentiality
Unique identification (ID) numbers will be assigned to all trial participants and identifying information will only be accessible to the authorised researchers. Paper copies of assessment tools will all be stored in locked filing cabinets in a secured office. All anonymised data will be stored in an encrypted and password protected excel database. Interviews and focus group discussions will be digitally recorded with participants' consent to record. The interviews will then be transcribed. Recordings will be stored in a secure location and will be destroyed once the qualitative data is published. The quantitative data from the trial will be stored for 10 years in accordance to the Pakistan Institute of Living and Learning Data protection and Storage Policy.
Adverse event reporting
All the adverse events, whether pertaining to the study or not, will be recorded in detail. In case of a serious adverse event, the PI will immediately notify the collaborating investigators and the ethics committee. Patient safety will be ensured by taking all the appropriate measures.
Sample size
To have an effect size of 0.45, assuming 5% significance level, 80% power and 10% drop out (Husain et al., Reference Husain, Zulqernain, Carter, Chaudhry, Fatima, Kiran, Chaudhry, Naeem, Jafri and Lunat2017b) during the study, we need to recruit 300 parents. The objective for which the larger sample size is needed relates to the intra-cluster correlation coefficient (ICC), which measures the degree of similarity in outcome amongst parents in the same cluster; for this, the key is the number of clusters (Rutterford et al., Reference Rutterford, Copas and Eldridge2015). Moreover, groups (and hence clusters) of size around 10 is the optimal size for interventions such as LTP Plus TF-CBT (Biggs et al., Reference Biggs, Hind, Gossage-Worrall, Sprange, White, Wright, Chatters, Berry, Papaioannou and Bradburn2020). We propose a minimum of 15 clusters in each of the LTP + TF-CBT and routine care arms, in order to be able to obtain a relatively precise estimate of the ICC and to check whether it might be greater in the LTP + TF-CBT and routine care arms as the former may have additional variation due to the delivery of the group-based therapy. We, therefore, expect to recruit around 300 parents (approximately 10 each from 15 LTP + TF-CBT and 15 TAU clusters) which will enable the estimation of recruitment and retention rates with sufficiently good precision to inform a full effectiveness trial.
Assessment measures
Assessment of feasibility and acceptability
The feasibility of the intervention will be assessed by;
• ascertaining whether the intervention is delivered, received and enacted as intended
• session completion rate monitored through session logs
• through qualitative feedback described below
Acceptability of the intervention will be assessed by;
• percentage dropouts due to non-acceptability
• rate of serious adverse events
• through qualitative feedback described below
Demographic scale: A study-specific demographic scale will be used to collect demographic information such as age, education, employment status, socio-economic status etc.
Primary outcome
The Clinician-Administered PTSD Scale-5 (CAPS-5) is a 30 item scale and will be used as a primary outcome measure as this is the gold standard structured interview for assessing PTSD, diagnostic status and symptom severity (Weathers et al., Reference Weathers, Blake, Schnurr, Kaloupek, Marx and Keane2013). Questions target the onset and duration of symptoms, subjective distress, and impact of symptoms on social and occupational functioning. Research evidence with diverse cultures supports that CAPS is reliable and yields consistent scores across items (Weathers et al., Reference Weathers, Keane and Davidson2001).
Secondary outcomes
Patient Health Questionnaire (PHQ-9) (Kroenke et al., Reference Kroenke, Spitzer and Williams2001) to assess depression. The scale has been translated into Urdu and validated in Pakistan (Ahmad et al., Reference Ahmad, Hussain, Akhtar and Shah2018). The Urdu version has been used in previous trials in Pakistan (Husain et al., Reference Husain, Zulqernain, Carter, Chaudhry, Fatima, Kiran, Chaudhry, Naeem, Jafri and Lunat2017b, Reference Husain, Kiran, Shah, Rahman, Saeed, Naeem, Bassett, Husain, Ul Haq and Jaffery2020). The Cronbach's alpha for the PHQ-9 was reported to be 0.91 and the split-half reliability was 0.77 (Ahmad et al., Reference Ahmad, Hussain, Akhtar and Shah2018).
Generalised Anxiety Disorder Scale (GAD-7) (Spitzer et al., Reference Spitzer, Kroenke, Williams and Löwe2006) to assess anxiety. The scale has been translated into Urdu and validated in Pakistan (Ahmad et al., Reference Ahmad, Hussain, Shah and Akhtar2017). The Urdu version has been used in previous trials in Pakistan (Husain et al., Reference Husain, Zulqernain, Carter, Chaudhry, Fatima, Kiran, Chaudhry, Naeem, Jafri and Lunat2017b, Reference Husain, Kiran, Shah, Rahman, Saeed, Naeem, Bassett, Husain, Ul Haq and Jaffery2020). The Cronbach's alpha for the GAD-7 was reported to be 0.92 and split-half reliability was 0.82 (Ahmad et al., Reference Ahmad, Hussain, Shah and Akhtar2017).
Client Service Receipt Inventory (CSRI) (Beecham and Knapp, Reference Beecham and Knapp2001) will be used to collect information about the use of other health services (including the informal sector faith healers/Imams). The CSRI has been used in a previous trial in Pakistan (Husain et al., Reference Husain, Afsar, Ara, Fayyaz, Ur Rahman, Tomenson, Hamirani, Chaudhry, Fatima and Husain2014a).
Ages and Stages Questionnaire (ASQ-3) (Squires et al., Reference Squires, Bricker and Twombly2009) to assess physical, social, emotional and cognitive development of children.
Theory of Change (ToC)
The study team uses the Theory of Change approach as a standard framework for bringing about change. The community engagement process will be underpinned by the ToC (Mayne, Reference Mayne2020) causal model of planning, monitoring, evaluation and impact assessment to ensure that the marginalised voices are included in developing the vision. Barriers and challenges are identified through the lens of the end beneficiaries and short, medium and long term outcomes are developed and delivered so real change happens from the perspective of the target group. The ToC is closely embedded in community-based participatory research to engage the community for equity and to ensure that the process of Freirian collective reflection is in place. This reflection process aims to acknowledge the role of community knowledge and fit that can potentially impact the empowerment processes and consequently the power relations and greater equity outcomes within and outside partnerships (Wallerstein et al., Reference Wallerstein, Oetzel, Sanchez-Youngman, Boursaw, Dickson, Kastelic, Koegel, Lucero, Magarati and Ortiz2020). The proposed composition of the stakeholder group for this project is truly reflective of the participatory approach by engaging parents with mental health difficulties, CHWs, health professionals, members of non-profit organisations and researchers. The study's ‘Patient and Public Involvement and Engagement (PPIE)’ group will be part of the stakeholder group. People with mental health difficulties make a vulnerable, stigmatised and marginalised group of population in our society (Vigo, Reference Vigo2016). This is particularly true for female survivors of mental health problems in Pakistan (Niaz, Reference Niaz2004). The involvement of the PPIE group in the ToC process throughout the project will ensure that the marginalised voices to be heard.
In practical terms at the planning stage, a workshop with stakeholders including persons with lived experience (the end beneficiaries) as the key stakeholder will come together to explore various elements of the ToC process by developing a shared vision and defining goals in the short, medium and longer term. This stakeholder engagement exercise will help to clarify roles and responsibilities as to who does what and how to achieve the vision. Assumptions will be articulated in the current context. Through our ToC process, stakeholders will identify the social and cultural factors and when the context changes, we will hold further stakeholder workshops to test our assumptions together in order to adapt and refine our model accordingly and with the ownership of all stakeholders. The theory of change will also enable us to show that trial results have been adopted in practice. What barriers and challenges were faced during the trial? What assumptions were made in defining the goal statements? The ToC approach will help mitigate some of the risks around stigma and refusal to participate as a representative group is involved at the inception of the trial. Our ToC pathway will give a detailed and direct understanding of the links between activities that lead to the desired goals. This understanding will lead to better evaluation and measure of progress and in the long term an understanding of impact both planned and unplanned.
Statistical analysis plan
The study will be carried out in accordance with the CONSORT guidelines. All analyses will be based on the intention-to-treat sample and missing data will be imputed with multiple imputation procedures as implemented in Statistical Package for Social Sciences (SPSS) software (version 27). To assess the primary and secondary outcomes, a two-sided significance level of 0.05 will be employed to enable the detection of a difference between interventions in both directions. Demographics and baseline variables in the two study arms will be compared using various descriptive statistics of means, standard deviations, and proportions. For primary outcome analysis, a two-sample two-sided test of proportions will be used to compare the difference in the rate of PTSD (assessed using the CAPS-5) at 4-month post-randomisation between LTP Plus and TF-CBT and TAU groups. For the secondary analyses, we will compare the proportions similarly for binary outcomes and use tests for comparing means for the continuous outcome. Additionally, we shall use multivariable techniques in assessing the effect of various covariates including baseline measures on outcomes. If required appropriate transformation of continuous variables will be considered. ICC will be calculated to help future cluster-based research on this topic.
Qualitative component
In-depth digitally recorded interviews with participants and focus groups with key stakeholders will complement the quantitative data (Ritchie et al., Reference Ritchie, Lewis, Nicholls and Ormston2013). This is to draw out complex issues that quantitative methods may overlook and to explore possible mechanisms of change in parents. Qualitative evaluation will include narrative experiences of health care providers, school teachers and other stakeholders (CHWs) in the project. Focus Groups will also be held separately with the participants (parents) and other family members, at the end of participation to explore perceived barriers and facilitators to the successful delivery of the intervention and optimise a framework for subsequent implementation at a national level. Separate topic guides will be developed to be used in focus group and interviews with participants and other stakeholders.
All the qualitative interviews and focus group discussions will be digitally recorded and transcribed verbatim. The transcripts will be translated into English. Initial 3–4 transcripts in English will be back translated into Urdu to ensure accuracy. Data will be coded using NVivo software. The process of analysis will be iterative as data collection will progress, using the principles of constant comparison, until category saturation will be achieved. Framework analysis will be conducted to analyse and interpret the qualitative data (Kiernan and Hill, Reference Kiernan and Hill2018).
To maintain the credibility and trustworthiness of the data and subsequent findings, the researchers will be supervised by experienced researchers with expertise in qualitative methods (ZZ, TK). Sample of the transcripts will be discussed in regular meetings. Engagement in discussion and regular reviews by all researchers will help to ensure the fit of the data to the final analysis and help to minimise bias. Team members will agree the final theoretical framework and key themes and interpretations.
Summary and implications
There are limited data available from RCTs to guide treatment choices for clinicians in Pakistan caring for patients, particularly parents with PTSD. As a result, there is a need to test low-cost, culturally sensitive, psychosocial interventions (LTP Plus) for parental PTSD in Pakistan. This study is particularly relevant to the achievement of the Sustainable Development Goals (SDGs) such as Health and Wellbeing (Goal 3), gender equality and empowering women (Goal 5), reducing inequalities (Goal 10) and reducing poverty (Goal 1) (Nations, 2016). The proposed study is an important extension of more than 20 years of work looking at the aetiology (Husain et al., Reference Husain, Chaudhry, Afridi, Tomenson and Creed2007) and treatment of depression and anxiety in Pakistan (Husain et al., Reference Husain, Chaudhry, Fatima, Husain, Amin, Chaudhry, Ur Rahman, Tomenson, Jafri and Naeem2014b, Reference Husain, Zulqernain, Carter, Chaudhry, Fatima, Kiran, Chaudhry, Naeem, Jafri and Lunat2017b, Reference Husain, Kiran, Shah, Rahman, Saeed, Naeem, Bassett, Husain, Ul Haq and Jaffery2020), including a cultural adaptation of interventions (Naeem et al., Reference Naeem, Phiri, Munshi, Rathod, Ayub, Gobbi and Kingdon2015). In Pakistan, a parenting programme (Learning through Play-LTP) was tested for the first time through a cluster randomised study in a rural area of Rawalpindi, Pakistan (Rahman et al., Reference Rahman, Iqbal, Roberts and Husain2009) Results indicated that the intervention group had a significantly higher increase in questionnaire scores of maternal knowledge about infant development than the control group at 3 months postpartum (with women in the intervention group answering correctly 4.3 [95% confidence interval (CI) 3.7–14.9, p < 0.001] more questions than the control group) but there were no difference in SRQ-20 (distress) scores between intervention and control groups (Rahman et al., Reference Rahman, Iqbal, Roberts and Husain2009). A combination of a parenting programme (LTP) and Cognitive Behaviour Therapy was later tested with depressed mothers (Husain et al., Reference Husain, Zulqernain, Carter, Chaudhry, Fatima, Kiran, Chaudhry, Naeem, Jafri and Lunat2017b, Reference Husain, Kiran, Shah, Rahman, Saeed, Naeem, Bassett, Husain, Ul Haq and Jaffery2020). For both trials, at 3 months, there was a significant reduction in depression scores of mothers in the LTP Plus group compared to the control group. Since research supporting low-cost interventions is scarce, this trial would help build an understanding of the acceptability, feasibility and effectiveness of a low-cost parenting intervention and how it can help support parents experiencing trauma in Pakistan.
Supporting trauma survivor parents through stress reduction and management, parenting education and connecting them with others via group interventions can help them to positively impact the developmental trajectories of their children (Rosenblum et al., Reference Rosenblum, Muzik, Morelen, Alfafara, Miller, Waddell, Schuster and Ribaudo2017). Such interventions are particularly important in Pakistan where women and children are the most vulnerable population because of fragile health systems and natural disasters (Jafar et al., Reference Jafar, Haaland, Rahman, Razzak, Bilger, Naghavi, Mokdad and Hyder2013). A process evaluation nested in a pilot RCT from Pakistan highlighted that it is challenging for women to access facility-based mental health interventions (Rahman et al., Reference Rahman, Riaz, Dawson, Hamdani, Chiumento, Sijbrandij, Minhas, Bryant, Saeed and van Ommeren2016) therefore a community-based approach involving CHWs can be adopted to improve access to care (Chiumento et al., Reference Chiumento, Hamdani, Khan, Dawson, Bryant, Sijbrandij, Nazir, Akhtar, Masood and Wang2017).
Acknowledgements
We want to acknowledge our community workers and Khwenda Kor – a non-profit research organisation in Peshawar who helped us in identifying and recruiting potential community settings in Peshawar. We also want to acknowledge Dr Meher Husain for providing supervision to the research team. We also want to acknowledge our research team (Shafaq Shoaib, Maria Usman, Shankar Lal, Shahida Kausar, Omair Ahsen)
Author contributions
NC, NH, RM and TK were involved in the design of the study and protocol. SF is project lead and approaching and screening participants, coordinating with potential sites. FN reviewed the manuscript and will be involved in the training and supervision of the research team. FN developed BASID. MS and OEB reviewed the statistical analysis section. All authors contributed to the writing and editing of the drafts and approved the final submission.
Financial support
This study is funded by the Pakistan Institute of Living and Learning and the UK Association for Medical Aid to Pakistan (the UK registered charity number: 1123929).
Conflict of interest
NH has been a past Trustee of The Pakistan Institute of Living and Learning (PILL), Abaseen Foundation UK and Lancashire Mind UK. He is the chair of the board of trustees of Manchester Global Foundation (MGF) a Charitable Incorporated Organisation (CIO) registered in England and Wales. He is an executive member of the Academic Faculty at the Royal College of Psychiatrists, London. He is an NIHR Senior Investigator. He has received honorarium and travel grants from various pharmaceutical industries. NC is the CEO of the Pakistan Institute of Living and Learning. She is Associate Director of Global Mental Health and Cultural Psychiatry Research Group, Head of Psychological Medicine at the Remedial Centre Hospital, Consultant Psychiatrist at South City Hospital, Consultant for Manchester Global Foundation and Professor of Psychiatry, Dow University of Health Sciences. NC has received travel grants from Lundbeck and Pfizer pharmaceutical companies to attend one national and one international academic meeting and conference in the last three years. She is a chief investigator and co-investigator for a number of research projects funded by various grant bodies such as the Medical Research Council, Welcome Trust, NIH-R, and Global Challenges Research Fund. IBC is the -founder and former Trustee, Pakistan Institute of Living and Learning, Current, Chairman, Department of Psychiatry, Ziauddin Group Hospitals, Visiting Professor, Dow University of Health Sciences, Honorary Professor of Psychiatry, University of Manchester IBC is Executive Director, Remedial Centre Hospital, Nursing Home and Consultant for Manchester Global Foundation. IBC has received support for educational programmes and/or travel support and/or speaker fees from Astra Zeneca, Eli Lilly, Lundbeck, Sanofi-Aventis, Bristol, Myers Squibb, Janssen Cilag and Wyeth. He is a Senior Research Scientist, chief investigator, and co-investigator for a number of research projects funded by various grant bodies such as the Medical Research Council, Welcome Trust, NIH-R, and Global Challenges Research Fund with Pakistan Institute of Living and Learning.
Ethical standards
Full ethical approval has been sought from the ethics committee of the Institute of Professional Psychology (IPP), Bahria University Karachi, Pakistan. Written consent will be obtained from each participant prior to any trial-related data collection.
Trial status
This clinical trial was registered on 4th April 2018 (ClinicalTrials.gov, NCT03488290).
Open access
