Testing the feasibility and acceptability of an intervention to improve first-time fathers’ transition to fatherhood focusing on the role of mental health and wellbeing
PART A
1.1 Introduction
During the last decade there has been an increased policy emphasis on improving mental health and wellbeing among the general population in England (DH, 2011). Mental health has been highlighted as a priority by the European health and social agenda (European Commission, 2008) and internationally, by the World Health Organisation (WHO 2005). Mental health problems represent the largest single cause of disability in the UK, with the cost to economy estimated at £105 billion a year (Mental Health Taskforce, 2016). Moreover, the cost of treating mental illness is likely to double over the next 20 years (Trautmann et al, 2016; DH, 2011). As well as resource implications, mental health has profound effects on an individual’s quality of life, and physical and social well-being (WHO, 2003). There are also wider social impacts, which includes loss of productivity, reduced levels of education and increased rates of crime (DH, 2011). This, therefore is a major public health issue.
The focus on mental health and wellbeing particularly during the transition to parenthood is attracting more attention, especially as new parenthood brings about a number of changes and challenges for both the mother and father, but also because it is a time when parents are more likely to be in contact with relevant healthcare professionals and services. It can be a stressful time, with new adjustments to lifestyles and routines, which can significantly impact on the mental wellbeing of both parents (Asenhed et al, 2014; Genesoni and Tallandini, 2009; Deave et al, 2008). A report from the London School of Economics concluded that perinatal mental health problems carried a total economic and social long-term cost to society of about £8.1 billion for each one-year cohort of births in the UK (Bauer et al, 2014). This report however was based on costs relating to maternal perinatal mental health, and included estimates for adverse effects on the child as well as the mother, but not the father (Bauer et al, 2014). Similarly, the majority of research into perinatal mental health to date has tended to focus on women. The UK National Institute for Health and Care Excellence guidelines on antenatal and postnatal mental health (NICE, 2014) recommend routine assessment of mothers, but did not include any reference or recommendations for fathers. As a result maternal mental health needs during this period are more widely recognised by health professionals and support for mothers has improved. However, men’s mental health during their transition to fatherhood remains comparatively poorly understood and under-researched, with many new fathers’ needs often unmet (Paulson & Bazemore, 2010).
1.2 Significance of the study
The limited research into men’s mental health during their transition to fatherhood has mainly focused on anxiety and depression during their partners’ pregnancy and one year following birth. In a recent systematic review of forty-three papers, Leach et al (2016) reported a prevalence rate for any anxiety disorder in men ranged between 4.1% – 16.0% during their partner’s pregnancy and 2.4% – 18.0% during the 6-8 week postnatal period. In a separate meta-analysis which also included forty-three studies, Paulson and Bazemore (2010) reported a prevalence rate of depression in men both pre- and postnatally as 10.4%. Research from Denmark (Madsen et al, 2007) and the US (Paulson et al, 2006) showed that new fathers’ depression rates were double the national average for men in the same age group who were not fathers.
The period from an infant’s conception to the age of two is a crucial time for child development and experiences during this time are likely to influence the rest of the child’s life (Wave 2013). Similar to the impacts of maternal depression, a number of negative implications for the child have been associated with mental health problems in fathers. This includes a father’s capacity for sensitive parenting, where they may not be able to attune to their baby’s cues and signals, and respond accordingly. Studies have shown that fathers who are affectionate, supportive and involved in their child’s care and upbringing, contribute positively to their child’s cognitive, language and social development (Cabrera et al, 2007), with the potential to generate social, academic and economic benefits in the future (Sarkadi et al, 2008; Flouri, 2005; Pleck and Masciadrellin, 2004). Close connections with their children are linked to positive outcomes for fathers themselves, such as greater satisfaction with family life (Feldman et al, 2004), unusually high levels of satisfaction in mid-life (Snarey, 1993), and less likelihood of experiencing separation/divorce (Olah, 2001). Other benefits to fathers include greater skill acquisition, confidence and self-esteem (Lewis et al, 1982; Stile and Ortiz, 1999). Conversely mental health problems in fathers are associated with cognitive, emotional, social and behavioural problems in children (Ramchandani et al, 2005; Flouri, 2005; Brennan et al 2002; Phares, 1999). Fathers play a crucial role in supporting the health and wellbeing of their partners too (Fisher et al, 2006; Pilkington et al, 2015), and therefore support for new fathers and addressing their mental health needs could make an important contribution to the wellbeing of families and wider society.
Midwives and health visitors in the UK provide routine care to all pregnant and postnatal women and their partners (if present), as part of universal health services, with health visitors having the most extended period of contact. Therefore they are in an ideal position to offer interventions aimed at improving parents’ mental health and wellbeing during and beyond the 6-8 week postnatal period. The transition to parenthood was identified as one of six high impact areas by the Department of Health in England where early intervention can make a difference to family outcomes (DH, 2014). The national Healthy Child Programme (HCP) which was originally published in 2009 and its evidence reviewed and updated in 2015, recognised the importance of this early intervention and the need for health professionals to work effectively with parents to ensure that their children have the best start in life. As a result greater emphasis is placed on health visitors, as lead health professionals for the delivery of the HCP in England, to work more closely with fathers (PHE, 2015; DH, 2009). By focusing on a couple’s intimate relationship as well as the parenting relationship, health visitors can make a significant contribution to mental health and wellbeing of families with new babies (Coleman et al, 2013; Hewison, 2013).
In England every family with a child under the age of five will have access to a health visitor, who is required to undertake a minimum of five contacts (NHS England, 2014) as follows:
Through these contacts, health visitors can support parents in the transition to parenthood, promote child development, improve child health outcomes and ensure that families at risk are identified at the earliest opportunity (NHS England, 2014). The first three of the five contacts provide ideal opportunities to carry out comprehensive and holistic assessments of the expectant/ new mother’s and father’s needs. While clear guidance has been set out by NICE (2014) and the DH (2012) in England for assessing maternal mental health at these routine contacts, currently there are no national guidelines for assessing paternal mental health. This means that while the HCP emphasises the need for health visitors to work more closely with fathers, as mentioned earlier, there are no national guidelines for health professionals that recommends routine assessments of fathers’ mental health at these contacts, which represents a huge gap.
A recent report commissioned by the National Health Service (NHS) in England described the transformation necessary for prevention, access, integration, quality and a positive experience of care, relating to mental health over the next ten years (Mental Health Taskforce, 2016). While this report was based on mental health in the general population, the importance of focussing on maternal perinatal mental health was highlighted, but not paternal mental health. There are disparities between a growing evidence base, which suggest fathers’ mental health during the perinatal period is a significant issue, and national policy where assessment of fathers’ mental health is not highlighted within recommendations for routine practice. Consequently routine clinical practice around fathers’ mental health and wellbeing tends to vary significantly. Evidence to support the transition to fatherhood and the development, implementation and evaluation of effective interventions to promote and sustain their mental health and wellbeing are therefore important for policy and practice.
Many health visiting services across England use the Promotional Guide system, which is a programme to support the transition to parenthood by enhancing parental capacity and change in parenting attitudes and practices in a non-judgemental and supportive manner (Davis and Day, 2010). It consists of two guides, an antenatal guide used with both parents around 4 to 6 weeks before their baby is due, and a postnatal guide which is used around 6-8 weeks after the birth of the baby. The system is based on the Family Partnership Model and although designed for both parents, the HCP in England currently recommend its use with women during the antenatal contact and 6-8 week postnatal contact carried out by health visitors (PHE, 2015). It is currently used face-to-face, by health visitors trained in its use, taking approximately 60 minutes to complete each guide.
These guides include questions based around five core themes:
Although the guides focus on the transition to parenthood as a whole, they could potentially improve fathers’ mental health and wellbeing during this period through the following processes:
Since its inclusion in the Healthy Child Programme (DH, 2009), the first study examining the implementation of the Promotional Guides in the UK reported that the guides were rated highly by both providers (health visitor) and recipients (women) (Barlow and Coe, 2013). This was a mixed-method evaluation which aimed to assess the level of implementation and stakeholder perceptions. Although this was a very small study, qualitative findings from interviews with seven women suggested that they were overwhelmingly supportive and appreciative of the listening, support and guidance provided by the health visitors through the Promotional Guide contacts (Barlow and Coe, 2013). More recently, the ‘Rapid Review to Update Evidence for the Healthy Child Programme 0–5’ stated that “further research is needed to examine how effective promotional interviews are in identifying women in need of further support, and improving outcomes” (PHE, 2015; pp-40). Despite the lack of robust evidence, the Promotional Guides are now used by health visitors in eighty five NHS trusts across England. While there are a number of service audits currently taking place at sites where this intervention has been implemented, no primary research studies are currently underway (as searched on UKCTG and ClinicalTrials.gov website), and questions relating to the level of engagement and its acceptability especially by fathers remain unknown.
1.3 Defining the research problem
The research problems identified are twofold:
Firstly as highlighted above, there is limited research available in the area of fathers’ mental health and wellbeing in the perinatal period. While the evidence that is available suggests that the rates of mental health problems in new fathers and impacts on the family are significant, UK policies for maternal and child health services do not currently address this adequately. To support men’s mental health and wellbeing during their transition to fatherhood it is essential to understand their experiences and the specific needs they may have during this period. The first two of the three planned phases of this study are crucial in constructing a better picture of how mental health and wellbeing are experienced by first time fathers and what their perceived support needs are relating to this. Findings will contribute to the existing limited body of knowledge in this important area, while informing the development of more adequate support interventions for new fathers.
Secondly, the Promotional Guide system mentioned above is an intervention aimed at mothers and fathers to support their transition to parenthood. However, there is little is known about its effectiveness and use with fathers, including whether fathers are routinely offered the intervention, whether they are willing to participate in it and whether they find it helpful with respect to supporting their mental health and wellbeing. In recent years another parenting programme, the Family Nurse Partnership, based on the Family Partnership Model was rolled out in the UK with minimal evidence of benefit in a UK population, and a recent trial found no positive association with anticipated benefits (Robling et al, 2016). Therefore more research on the use of the Promotional Guide system is necessary to inform good practice. The third phase of this study investigates whether the Promotional Guide System has the potential to support fathers’ mental health and wellbeing needs during their transition to fatherhood, and the health professionals’ views of delivering the intervention to fathers. This phase of the study will explore the level of engagement, feasibility, acceptability, fidelity of delivery and reported impact on first-time fathers’ mental health and wellbeing.
1.4 Research aims & objectives
The primary aim of this research is to explore first-time fathers’ needs and experiences during their transition to fatherhood (defined as the period from conception to one year after birth), with a particular focus on their mental health and wellbeing. Phases 1 and 2 of this study will provide evidence to support better understanding of the experiences of first time fathers and the level of information and support they consider could help their mental health and wellbeing. Barriers and facilitators to first time fathers’ access to help or support will be also be identified.
The secondary aim is to test the feasibility of health visitors’ use of the Promotional Guide System with first time fathers, and assess if the new fathers found this to be an acceptable intervention which met their mental health and wellbeing needs. The findings of phase 3 of the study could help inform the development of a definitive trial, as well as highlight current gaps in meeting first-time fathers’ needs and how these could be addressed.
There are three research questions which will be answered through the three planned study phases:
Research question 1: What is already known about men’s mental health and wellbeing during their transition to fatherhood?
Study phase I: A systematic review of the qualitative evidence of first time fathers’ needs and experiences of transition to fatherhood in relation to their mental health and wellbeing.
Research question 2: How do first-time fathers perceive their mental health and wellbeing needs during this transition?
Study phase II: An in-depth qualitative study to explore first time fathers’ experiences and perceived mental health and wellbeing needs during their transition to fatherhood.
Research question 3: Is the use of the Promotional Guide System acceptable to first-time fathers as an intervention to support their mental health and wellbeing, and to the health professionals responsible for delivering the intervention? How feasible is the implementation of the Promotional Guide system with new fathers by health visitors as part of their routine practice and what is the fidelity of programme delivery?
Study phase III: A feasibility study of the use of the Promotional Guide system by first-time fathers to support their mental health and wellbeing, and the health professionals responsible for delivering the intervention.
Title: First time fathers’ needs and experiences of transition to fatherhood in relation to their mental health and wellbeing: A qualitative systematic review.
2.1 Review question/objective
This qualitative review seeks to identify first time fathers’ needs and experiences in relation to their mental health and wellbeing during their transition to fatherhood. This will include resident first time fathers who are either the biological or non-biological father.
The objectives are to focus on first-time fathers’ experiences in relation to:
2.2 Definition of key concepts
2.3 Method
A qualitative approach was chosen for the systematic review as it allows exploration and analysis of human experiences, as well as social and cultural phenomena which may influence experiences to be captured as well (Denzin and Lincoln, 2005). This method is necessary to identify and understand first time fathers’ needs and experiences in relation to their mental health and wellbeing, and identify the perceived barriers and facilitators to accessing support.
The systematic review is being conducted through the Joanna Briggs Institute (JBI), with training and review support provided by The Centre for Evidence Based Healthcare at Nottingham University, a designated Centre of Excellence within the JBI global network. The review title has been registered with JBI, and the protocol has been published in the JBI Database of Systematic Reviews and Implementation Reports and PROSPERO (Appendix – A). The findings of the systematic review will inform the content of the qualitative interviews in the next phase of the study and allow exploration of aspects relating to men’s transition to fatherhood.
The review questions were developed using the PICo mnemonic for qualitative research (Table 1).
Table 1: Structuring the research questions using PICo
| Population (P) | Expectant or first time fathers of infants under 12 months of age. |
| Phenomena of interest (I) | First time fathers’ needs and experiences during their transition to fatherhood in relation their mental health and wellbeing. |
| Context (Co) | Between conception and up to 12 months postnatally. |
This review considered studies that included resident first time fathers (biological and non-biological) during their transition to fatherhood, from pregnancy commencement until one year after birth. Study participants included first time fathers of healthy babies born with no identified terminal or long term conditions.
Certain groups of fathers may have specific mental health needs during their transition to fatherhood. As this review focuses on the mental health and wellbeing of fathers in general and not of those with specific additional needs, the following were excluded:
This review considered studies undertaken in high income countries as defined by the World Bank (2016) (for example countries which are members of the European Economic Community, the UK, the United States, Canada, Australia and New Zealand) that investigated first time fathers’ experiences, during any time from conception to one year after birth. The majority of these countries have similar healthcare systems (with a mix of public and privately funded and universal service provision), social and political systems, meaning that review findings are likely to be more transferable.
The search strategy aimed to identify published and unpublished studies. A three-step search strategy was utilised. An initial limited search of MEDLINE (using Ovid) and CINAHL was undertaken followed by analysis of the text words contained in the title and abstract, and of the index terms used to describe the article. A second search using all identified keywords and index terms was then undertaken across all included databases. Thirdly, the reference list of all identified reports and articles was searched for additional studies.
Studies published in English were considered for inclusion in this review due to the difficulties associated with resources for translation. Searches of bibliographic databases for studies published between 1960 and April 2017 were considered for inclusion due to the changing role of fathers’ which gradually took place over the second half of the 20th century (Milkie and Denny, 2014; Atkinson and Blackwelder, 1993). A full list of all databases searched and papers identified are presented in Appendix – B. Keywords used for the searches are presented in Appendix – C, and the search results in Appendix – D.
The development of the systematic review is in progress at the time of preparing this report and selected papers are being assessed for methodological quality independently by two reviewers (SB and DB).
Qualitative papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Qualitative Assessment and Review Instrument (JBI-QARI) (Appendix – E). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer (JS).
Qualitative data will be extracted from papers included in the review using the standardized data extraction tool from JBI-QARI (Appendix – F). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives.
2.8 Data synthesis
Qualitative research findings will where possible be pooled using JBI-QARI. This will involve the aggregation or synthesis of findings to generate a set of statements that represent that aggregation, through assembling the findings rated according to their quality, and categorizing these findings on the basis of similarity in meaning. These categories are then subjected to a meta-synthesis in order to produce a single comprehensive set of synthesized findings that can be used as a basis for evidence-based practice. Where textual pooling is not possible the findings will be presented in narrative form.
Title: Exploratory study of first time fathers experiences and perceived mental health and wellbeing needs during their transition to fatherhood.
3.1 Research Question/ Aims
Research Question: How do first-time fathers perceive their mental health and wellbeing needs during their transition to fatherhood?
The aim of this study is to create wider understanding of first-time fathers’ mental health and wellbeing experiences during their transition to fatherhood by exploring new fathers perceived needs, as well as further exploring the findings from the systematic review and any unknown aspects of it.
A qualitative research design informed by a phenomenological approach was chosen. Phenomenology is a qualitative strategy which enables the researcher identify the essence of human experiences about a phenomena as described by the participants in the study (Creswell, 2014). The notion of fatherhood is considered a social construct (Mead 1969), and it is based on the ontological belief that multiple realities of fatherhood are constructed through individual father’s lived experiences, their interactions with others as well as through historical and cultural norms that operate in individuals’ lives (Creswell, 2003). As the aim of this study is to increase understanding of fathers’ experiences during their transition to fatherhood relating to their mental health and wellbeing, this philosophical framework would allow the exploration of fathers’ individual interpretations of their lived experiences and the ways in which they express them (Parahoo, 2006).
Phenomenological approaches emphasise the importance of personal perspective and interpretation and epistemologically based in a paradigm of personal knowledge and subjectivity. The interpretive and exploratory nature of the research question is consistent with a phenomenological research tradition rather than that of generating theory or explanatory models, and therefore a grounded theory design was ruled out. In qualitative research it is recognised that the researcher’s own background and experiences can impact on the interpretation of the participants meaning of their experiences, however an essential component of phenomenology is ‘bracketing’, which allows the researcher to disconnect from their own experiences in order to understand those of the participants in the study (Nieswiadomy, 1993).
In-depth interviews will be carried out with up to 20 fathers depending on when data saturation is deemed to have been reached. With respect to achieving saturation, while there are no definitive numbers, according to Green and Thorogood (2009, p.120), “the experience of most qualitative researchers is that in interview studies little that is ‘new’ comes out of transcripts after you have interviewed 20 or so people”. Initially qualitative interviews and focus group methods were explored, but feedback from a local fathers’ group in a children’s centre who provided expert PPI during the design of the study helped influence the chosen method. In this PPI group, new fathers were of varying ages and from diverse cultural and ethnic backgrounds. They expressed that individual one to one interviews would be preferable to a focus group approach, which would enable fathers to talk more “openly and honestly”. Qualitative interviews are also likely to produce data rich in nature; and due to the interviewer being able to assess the participant’s level of understanding, reduce the danger of questions being misinterpreted (Polit and Beck, 2013).
Fathers will be recruited from two sites (as detailed below) through a number of different routes using posters, leaflets (Appendix – G) and invitation letters (Appendix – H) developed specifically for the study, which explain the aims and objectives and how to contact the researcher. Health visitors during their routine ‘New Birth’ contacts, and midwives during their routine postnatal contacts will be asked to offer invitation letters and study leaflets to all first-time fathers who meet study inclusion criteria. In cases where the father is not present during the contact, these will be offered to their partners. Recruiting fathers through their partners is considered to be a helpful strategy by the Fatherhood Institute, which is the leading charitable organisation for fathers and fatherhood in the UK (www.fatherhoodinstitute.org). The researcher will also approach local religious, community and social groups to disseminate study leaflets and posters. Approaching religious and community groups was shown to be particularly effective in recruiting fathers from African and African-Caribbean communities (Williams et al, 2012). In addition to this, local father’s groups, GP practices, health centres, children centres, nurseries, child health clinics, and sports and recreation centres will be asked to display the study poster and disseminate leaflets.
Only first-time fathers with children under 12 months of age will be included. Maximum variation sampling will be used to ensure diversity in ethnicity, age, religion, education levels, and social class, where possible. The sites chosen for this study have diverse and multicultural populations, with minority ethnic groups representing between over 44 – 69% of the total population (ONS, 2011). Fathers from different backgrounds may exhibit a wide range of attributes, behaviours, experiences, incidents, qualities and situations, and therefore this sampling technique will allow the identification of common themes that are evident across the sample. Participation will on a voluntary basis, details of which are outlined in the participant information sheet (Appendix – I) and written informed consent (Appendix – J) will be obtained. Prior to obtaining consent, the researcher will discuss the inclusion/ exclusion criteria with the participant and only those meeting the criteria will be included. Table 2 outlines the inclusion and exclusion criteria for this study.
Table 2: Inclusion / Exclusion Criteria for study phase 2
| Inclusion Criteria | Exclusion Criteria |
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Ealing, Brent and Harrow, served by London North West Healthcare Trust, and Lambeth and Southwark, served by Guy’s and St. Thomas’ NHS Foundation Trust have been selected as the study sites to represent fathers from inner London and outer London boroughs. These boroughs have diverse and multicultural populations, with minority ethnic groups representing over 44% of the total population Lambeth (Lambeth Council, 2016), 48% in Southwark (Southwark Council, 2015), 69% in Harrow (ONS, 2011), 64% in Brent (Brent Council, 2014) and 50% in Ealing (Ealing Council, 2012). As a health visitor, the researcher has good links with health visiting managers in both NHS settings. Preliminary discussions have already taken place with the managers and they are supportive of this study.
A topic guide will be developed for the qualitative interviews to provide structure and focus to the research questions. The guides will reflect findings from the systematic review and input from the PPI group of fathers, which has been specifically set up to provide Expert PPI to this project. Each interview will be audio-recorded with the participant’s permission and each participant will be offered an opportunity to check their interview transcripts for accuracy prior to analysis. A draft interview topic guide has been developed (Appendix – K), however the definite guide will be based on the findings of the systematic review. Each interview is likely to last for around 45-90 minutes and will be undertaken in settings ensuring privacy. This may be the participant’s home or a community setting. The researcher will follow the Trust’s Lone Worker policy and ‘Working Safely at King’s’ (KCL, 2009) policy to ensure personal safety.
Data will be analysed using Interpretive Phenomenological Analysis (IPA) (Smith, 2011), a method which combines interpretative processes to help understand and uncover meaning of the phenomenon under scrutiny based in a social context (Larkin et al, 2006). IPA acknowledges that while the researcher tries to make sense of the participant’s world, their own conceptions will affect the way in which they interpret that information, and therefore requires the use a dual faceted approach – phenomenological and interpretative analysis (Smith et al. 1999). This method was chosen over other descriptive phenomenological approaches (Collaizzi 1978; Giorgi, 1985; Moustakas, 1994) as it would allow fathers to express their own experiences and needs, while also allowing the researcher to contextualise the broader themes and concepts (Larkins et al 2006).
The 5 step approach outlined by Smith and Osborn (2011) below will be used to analyse the data:
Title: A feasibility study of the use of the Promotional Guide system by first-time fathers to support their mental health and wellbeing, and the health professionals responsible for delivering the intervention.
4.1 Research questions/ aim
The aim of the feasibility study will be to consider if use of the promotional guide system is acceptable to first time fathers. It will test study procedures and gain feedback on the feasibility and acceptability of the intervention, and pilot the outcome measures, which can then be used in a future main trial (Cambell et al, 2000). Important parameters such as first time fathers’ willingness to participate, health visitors’ willingness to recruit fathers, the characteristics of the proposed outcome measure, response rates to questionnaires, and follow-up rates will be considered. A process evaluation will be undertaken to consider the acceptability, feasibility and fidelity of programme delivery of the system. Impact on first time father’s mental health and wellbeing outcomes will also be considered. It will explore:
4.2 Method
A prospective observational cohort study will be conducted incorporating both quantitative and qualitative data collection methods. Feasibility will be assessed using recruitment and retention rates, data completeness; and acceptability by quantitative survey, qualitative interviews and observations. Currently little is known about the use of the Promotional Guide system with fathers, such as whether fathers are routinely offered the intervention, whether they are willing to participate and whether they find it helpful. A process evaluation, following Steckler and Linnan’s (2002) framework will be undertaken as it provides a logical approach to evaluating the intervention, as outlined in Appendix – L. A process evaluation within this phase would enable better understanding of the causal assumptions underpinning the intervention and how it works in practice, which are vital in building an evidence base that informs policy and practice (Craig et al, 2008).
While randomised controlled trials (RCTs) are considered to be the ‘gold standard’ and the most robust method for assessing effectiveness of interventions due to the processes used during the conduct minimises the risk of confounding factors influencing the results (Evans, 2003), a RCT was not considered to be appropriate for this particular study. Firstly, the Promotional Guide System is an intervention that is delivered by health visitors universally to all parents and therefore it would be difficult to exclude a group of fathers from receiving this intervention.
Secondly, this study is testing the feasibility and acceptability of the Promotional guide system, which can be achieved through a cohort study design (Chaudron et al, 2004). Thirdly, a RCT would require additional time and resources, which is not practical for this study which is being undertaken as part of a doctoral programme. Following this feasibility study, the plan would be to undertake a definitive trial as part of a post-doctoral research study.
4.2.1 Recruitment
Expectant fathers will be recruited from antenatal clinics and health visitor contacts using leaflets, posters (Appendix – M) and participant information sheets (Appendix – N). Midwives will be asked to offer leaflets to fathers and their partners during routine antenatal contacts after 20 weeks gestation. Health visitors will be asked to send out study leaflets to fathers when informing them about the antenatal Promotional Guide contact which is usually before their partner reaches 28 weeks gestation. Details of the study website with information about the study and how to participate will be included in study posters and leaflets, which fathers who are interested will be able to follow. In addition to this, the researcher will recruit expectant fathers from the antenatal scan departments in the hospitals within the two sites. First time fathers attending the routine 20 week scan appointment will be asked whether they would like to participate in the study and those interested will be offered further information, including the leaflet and participant information sheet.
Once fathers who are interested in participating contact the researcher, the study procedure will be explained in detail face-to-face where possible or over the phone, and fathers who wish to take part will be given details on how to complete the questionnaires. Written consent will not be necessary as by completing the questionnaires it will imply that they are consenting to take part in the study.
4.2.2 Sample size
As this is a feasibility study, the sample size will not be powered to detect statistically significant differences in outcomes of interest. Rather than looking for effectiveness of the intervention. The findings from this study could inform future sample size calculation.
In total up to 50 first-time fathers will be recruited, 25 from each site. Teare et al (2014) recommend that an external pilot study which aims to estimate key parameters for the design of the definitive trial, has at least 70 measured subjects (35 per group) when estimating the SD for a continuous outcome. This suggests that 35 fathers would be sufficient for this type of cohort study. However to allow for drop-out and to enable more reliable estimates of change in the outcome measures, up to 50 fathers will be recruited across the two sites.
4.2.3 Data Collection
We will consider if the selected measures are appropriate for study aims and objectives, whether they are acceptable to fathers and whether fathers are willing to complete them at the proposed follow up times, with a view to using in a potential future definitive trial.
Fathers willing to participate will be directed to the study webpage to complete an online baseline questionnaire (Appendix – O) containing questions regarding the fathers socio-demographic details and study outcome measures between 24-28 weeks of their partner’s pregnancy. This questionnaire needs to be completed prior to their antenatal Promotional Guide contact with the health visitor, which usually takes place between 8-12 weeks before the expected date of delivery. These fathers will then be asked to complete two further questionnaires (Appendices – P & Q) at three and six months after the birth of their baby. These questionnaires will include some process measures, as well as the information in the baseline questionnaire. The postnatal promotional guide contact is typically delivered around 4-8 weeks after the birth of the baby and therefore these questionnaires will be completed at least one month after the postnatal Promotional Guide contact and again at least four months later. Reminders to complete the second and third questionnaires will be sent via email or text messages by the researcher. Fathers who do not have access to the internet will be directed to contact the researcher, who will send out postal questionnaires with prepaid return envelopes at the three different stages.
Feasibility of completing the range of measures planned, including completion and response rates will be assessed.
4.2.4 Outcome measures
Quantitative data: first time fathers
Three validated psychological health measures along with validated measures to assess general health, couple relationship and perceived social support have been selected, as follows:
Please refer to Appendix – R for further details on these outcome measures.
Qualitative data: first time fathers
A sub-group of 15-20 fathers from the same cohort will be invited to participate in in-depth qualitative interviews following the completion of the third questionnaire or 6 months following the birth of their baby. The groups of fathers that will be invited in the interviews are outlined in table 3.
| Table 3: Fathers who will be invited to participate in the qualitative interview |
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The interviews will be conducted using an interview topic guide (Appendix – S). This will enable better understanding of the processes and underlying mechanisms in relation to context, setting, professionals and patients (Byng et al 2008; Jansen et al, 2007). A choice of face-to-face and telephone interviews will be offered and written consent will be obtained prior to these interviews.
Health Visitors
A purposive sample of 10 health visitors across both sites, who have had experience of delivering the Promotional Guides will be interviewed to assess feasibility of delivering this intervention to fathers. The researcher will liaise with the managers of the health visiting teams within both Trusts in the first instance and ask them to disseminate information about the study amongst their teams. Health visitors working within both trusts will be informed about the study through staff meetings and emails, and will be invited to participate in either an in-depth interview about their Promotional Guide visits or to participate in observations of their Promotional Guide contact. An invitation letter has been designed (Appendix – T), which will be used for recruiting health visitors. Participation will be on a voluntary basis and those interested in participating will be given the participant information sheet (appendix – U) and asked to sign a consent form (Appendix – V), so that they can make an informed choice about their participation. The plan is to conduct 5 qualitative interviews and 5 observations at each site.
An interview topic guide will be used for these qualitative interviews (Appendix – W), which may be carried out by telephone or face-to-face. In addition to this observation of 10 health visitors across both sites carrying out the Promotional Guide contact will be undertaken to assess feasibility and fidelity. A fidelity checklist will be used during these observations (Appendix – X).
A combination of quantitative data on key process variables from all participants with in-depth qualitative data from samples purposively selected along dimensions expected to influence the functioning of the intervention is considered to be useful in process evaluations of interventions (Moore et al, 2015).
Inclusion Criteria:
Fathers
Health Visitors (Phase – 3 only)
Exclusion Criteria:
Fathers
Health Visitors (Phase – 3 only)
Quantitative data
Analysis of quantitative process data will begin with descriptive statistics relating to questions such as fidelity, dose, and reach. Analysis of the outcome measures at baseline along with recruitment rates, intervention participation, and withdrawal will include calculating the mean and standard deviation for approximately normally distributed continuous variables, medians and inter-quartile ranges for non-normally distributed variables, and frequencies and percentages for categorical variables. Mean and standard deviation estimates for pre-post change in SWEMWBS, EPDS, GAD7, EQ-5D, CSI and MSPSS will be computed and used to inform sample size calculations for a larger study. Data will be analysed using the latest version of IBM SPSS.
Qualitative data
The qualitative data will be analysed using framework analysis using NVivo version 10. Framework analysis is a method which enables in-depth exploration of data while simultaneously maintaining an effective and transparent audit trail, which enhances the rigour of the analytical processes and the credibility of the findings (Ritchie and Lewis, 2003). A framework to guide the stages of data analysis will help the Student Researcher develop the skills required to undertake robust qualitative data analysis, with support from the expert supervisory team.
The feasibility study (Phase 3) will be developed based on findings from phase 1 and 2 of this study and therefore is likely to be subject to further development.
This thesis will be presented in six chapters. The first chapter will present an introduction to the topic, and outline the research problem, objectives of the study and define the central ideas and concepts. It will also provide an overview of the background literature and rationale for the chosen research methodology.
The second chapter will present a review of all literature relating to fathers’ mental health and wellbeing during their transition to fatherhood. This will include the definition of mental health and wellbeing, the changes fathers’ may experience with regards to their mental health and wellbeing during this period, the risk factors, signs and symptoms, impact of poor mental health and any literature on interventions to support fathers’ mental health and wellbeing.
Chapter three will present results from phase 1, which is a qualitative systematic review conducted through the Joanna Briggs Institute. This chapter will describe the literature search process, present the findings of the review and conclude with implications for practice and research.
Chapter four will present phase 2, which is a qualitative study of first-time fathers. It will present the theoretical framework for the study, the study aims and objectives, rationale for the methodology, as well as details of data collection, findings, limitations and implications for practice and research.
Chapter five will present phase 3, which is a feasibility study. This chapter will provide a background to the intervention being tested, the theoretical framework, research aims and objectives, rationale of methodology used and conclude with presenting the finding and recommendations of this study.
Chapter six is the final chapter of this thesis, where an overview of the whole research project will be presented. It will discuss the study findings of each stage and how they link with each other. It will also discuss the overall findings in the context of existing literature, any limitations and implications for practice, policy and future research. In this chapter the author’s reflections of the whole project will also be included.
5.1 Outline of the proposed thesis chapter by chapter
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