Discussion

Our pilot RCT has demonstrated that the intervention has good acceptability and feasibility, but has only shown positive indicative impact on one of the social support measures: positive functional support. These findings are consistent with our previous work, where we conducted a case series with a uncontrolled treatment cohort of AFMs, and again found positive changes only in social support [in fact, that study showed positive changes in both positive functional support and positive alcohol, drugs and families specific support, as well as an increase in strain and engaged coping (Nadkarni et al., Reference Nadkarni, Bhatia, Velleman, Orford, Velleman, Church, Sawal and Pednekar2019)]. However, these findings are inconsistent with most other 5-Step Method work outside India. In almost all major evaluations of the intervention, the 5-Step Method has led to significant reductions in strain, and a reduction in engaged and tolerant coping (Copello et al., Reference Copello, Templeton, Orford and Velleman2010a, Reference Copello, Templeton and Powell2010b). A key question therefore is how to account for these differences. One potential attribution is that they might be related to how culture influences the experiences of AFMs. It has been suggested that different cultures and contexts influence the accumulated burden that AFMs hold, and the social support available for them; and that these differences may influence the core AFM experience (Orford, Reference Orford2017). This is especially true for our setting where our previous work has demonstrated both high levels of burden and the inaccessibility of effective social support (Church et al., Reference Church, Bhatia, Velleman, Velleman, Orford, Rane and Nadkarni2018).

The high uptake and completion of the intervention suggest that it was acceptable to family members; and indicate that there was a felt need for the intervention, it was possible to identify AFMs through gatekeeper or self-referrals, and it was acceptable to participants. Also, it implies that a program focused on AFMs can be implemented in this context with good initiation and follow-up rates. Further, in resource-constrained settings, it is feasible and acceptable to train lay counsellors to deliver a psychosocial intervention for families in community settings. From the perspective of evaluation research, it is possible to efficiently implement procedures that are critical in conducting a definitive RCT of the SAFE intervention, which had been our planned next step.

However, despite the fact that feasibility studies are not powered to assess effectiveness, our quantitative findings raise several questions. Does the fact that, for the participants receiving SAFE, stress and strain did not significantly reduce, and there was an increased use of coping methods which studies in other countries have suggested may be less helpful ways of coping, suggests that the intervention may (or does) not work in our context? Although our study cannot empirically answer that question, we can speculate about a number of potential explanations. First, the philosophical focus of the intervention may not be the best ‘cultural fit’ for the Indian context. The intervention is focused solely on empowering family members in their own right, and is thus a significant shift from the traditional neglect or token involvement of family members to direct engagement/focus on family members. In a ‘collectivist’ culture such as India which ascribes greater importance to the family as a unit, the focus of the SAFE intervention on the individual may have led to a mismatch. To illustrate this point, we would like to draw upon one of our anecdotal experiences from our process and qualitative work. AFMs strongly asserted that although they were burdened, their primary interest was not to receive help for themselves; instead their preference was that their drinking relative should engage in any form of treatment, and change his drinking behaviours, which would make ‘all their problems go away’. Hence, it may be that AFMs in our context retained a focus on the drinking relative and did not see the appropriateness or the possible usefulness of an intervention which might exclusively support the AFMs. The intervention was developed and has been used elsewhere in order to help AFMs in their own right by focusing on their coping and support systems; and it is possible that the AFMs whom we recruited in this context did not want this or understand its potential helpfulness, and instead wanted an intervention which would persuade their drinking relatives to seek treatment. As a result, by focusing on how they as AFMs were experiencing the impact of their drinking relative, our intervention may have increased stress and strain in family members.

Another possibility could be that the health of these AFMs did not improve because their situation remained the same: the drinker had not stopped drinking (which was their primary perceived need), and hence their perception might have been that ‘nothing had changed’ and hence they did not change either.

A related point is that this sample scored considerably lower on especially stress (FMI), but also on strain (SRT) than have other samples drawn from other countries and cultures [pre-treatment FMI scores in other countries are typically in the range of 30, whereas pre-treatment FMI scores in this sample were 19.84 (SAFE arm) and 21.74 (EUC arm); pre-treatment SRT scores range from 28.5 to 36.8, whereas here they were 23.25 (SAFE) and 21.48 (EUC)] (Copello et al., Reference Copello, Templeton, Orford and Velleman2010a, Reference Copello, Templeton and Powell2010b). The culture in India creates a situation where women are made to ‘accept their lot’ and as a result accept that they have to live with men who drink too much, and that sometimes they suffer as a result of that; and hence many women are relatively fatalistic about this (Stanley, Reference Stanley2012). Perhaps, by getting AFMs to undergo five sessions of a counselling intervention which got them to reflect on this situation, and by discussing change, it may have allowed these AFMs to realise that the impact and the effects on themselves were even worse than they had previously considered. Related to this, the intervention focuses on ‘alternatives to current ways of coping’ but in the study context it is possible that many of these AFMs might have felt that their alternatives were so limited that they could not change their situations. Hence our intervention may have raised awareness and self-reflection (e.g. regarding the negative impacts and their own responses), without alleviating any problems (e.g. getting the husband to stop drinking; or generating reasonable alternatives to current ways of coping). Again, there is some corroboration for this view, in that the style of coping which increased in this sample was engaged coping, one in which the focus is very much on the drinker and the drinking.

One further alternative explanation could be that the brief nature of our intervention was not adequate to lead to any longer-term positive changes in AFMs, especially in a context where ‘talking therapies’ are a novel and quite alien concept (Murthy, Reference Murthy2014).

A different explanation might relate to the competency of counsellors in delivering the 5-Step Method, which in previous studies has been delivered by specialists (Copello et al., Reference Copello, Templeton, Orford, Velleman, Patel, Moore, MacLeod and Godfrey2009; Velleman et al., Reference Velleman, Orford, Templeton, Copello, Patel, Moore, Macleod and Godfrey2011). It could be argued that the treatment quality could have been affected because the delivery agents were not trained professionals, but were lay counsellors. However, there is an extensive evidence base of the effectiveness of non-specialist health worker-delivered mental health interventions in LMICs (van Ginneken et al., Reference van Ginneken, Tharyan, Lewin, Rao, Meera, Pian, Chandrashekar and Patel2013; Nadkarni et al., Reference Nadkarni, Weiss, Weobong, McDaid, Singla, Park, Bhat, Katti, McCambridge, Murthy, King, Wilson, Kirkwood, Fairburn, Velleman and Patel2017; Patel et al., Reference Patel, Weobong, Weiss, Anand, Bhat, Katti, Dimidjian, Araya, Hollon and King2017; Singla et al., Reference Singla, Kohrt, Murray, Anand, Chorpita and Patel2017).

Our recruitment strategy may also explain the characteristics of participants, and the mixed results we found. We recruited participants through self and gatekeeper referrals, which meant that our sample would have included both those who were treatment seekers, and those who were not seeking treatment for their experiences or problems. Recruiting non-treatment seekers meant that there may have been a sub-group of participants who were less likely to fully engage in treatment, and report positive change (the lower levels of reported stress and strain offer some corroboration for this). Finally, it may be that the quantitative measures we have used are not culturally sensitive and adequate enough to capture actual and relevant changes that AFMs experience in their lives.

The second fundamental question is about the differential direction of change across the various domains of the experience of AFMs: Why did only social support scores increase? One of the predictors of future help-seeking is past experience of accessing help. In an Australian study, AFMs reported that positive help-seeking experiences in the past made them more likely to access services (McCann and Lubman, Reference McCann and Lubman2018). Our intervention provided AFMs with a safe space where they felt heard, and attempted to empower them to cope better; but for many this was the first such help that they had ever accessed. It is possible that the positive experiences that AFMs experienced during the SAFE sessions may have increased the likelihood of further help-seeking and hence led to an increase in social support scores.

Despite the improvement in perceived support, there was no positive change in the other domains of the SSCS model, and this could suggest a number of possibilities. One is that positive impact in this sample may only be seen over a longer time span. Alternatively, the available social support structures were perhaps not adequate, in terms of whether these were accessible, or even the quality of support offered. Hence, although there may have been increased support, the impact of the support in terms of improving the situation of AFMs may not have been positive. Given the relatively inextricable contexts that AFMs come from, this increased support may have not led to any significant change in the stress, strain and coping of AFMs. Finally, the increased support reported by the AFMs could actually be the support provided by lay counsellors through the SAFE intervention. This explanation is also likely given that our previous work has demonstrated the inaccessibility of social support (Church et al., Reference Church, Bhatia, Velleman, Velleman, Orford, Rane and Nadkarni2018).

To conclude, there are five major implications of our results. First, the fast recruitment and high acceptance rates for the intervention demonstrate that there is a great need for interventions aimed at AFMs in this context; and the high adherence rates demonstrate that the AFMs found the experience of receiving the intervention relevant and helpful. Both our anecdotal and qualitative data suggest that the large majority of the AFMs who received the intervention felt that they needed an intervention, stated that they felt better as a result of it and appreciated their meetings with their counsellors. These findings then reinforce what is known from other studies in India and elsewhere: that AFMs carry a high burden and a there is a major need for interventions to reduce this burden.

Second, we now have a better understanding of how this intervention worked in the setting. We found that AFMs in both arms showed at the time of the 3-month follow-up greater levels of stress and strain than at baseline, and that those in the intervention arm both increased the amount of engaged coping they used and reported greater changes in positive social support. Clearly this study was not powered to demonstrate significant results, but these preliminary findings strongly suggest that this intervention did not lead to expected changes – that is to reductions in especially strain (symptoms) and in AFMs generally feeling more empowered and more ‘in control’ of their situation. The rise in engaged coping suggests instead that, by focusing their attention on their situations, the intervention caused these AFMs to attempt to intervene at an even higher level than they had done before, yet with them still not being able to change the situation.

This relates to a third implication; that the intervention did not address the most pressing problem for these AFMs, which was to ensure that their relative with a drinking problem received effective treatment and stopped drinking. In some ways this is not an uncommon issue within the 5-Step Method, where many AFMs come for help with a focus on their problem relative. But in this context, it proved extremely challenging to assist these AFMs to see that if they were able to change their own behaviour, and to develop alternative ways of dealing with the problem, this might improve relationships in the family, and reduce their stress and strain. Our counsellors reported that many AFMs seemed extremely ‘stuck’, or alternatively lived in contexts where change seemed exceedingly difficult, and found it very problematic to generate alternative coping strategies, even with considerable help from the counsellors. One solution to this might be to broaden the scope of such interventions, for instance, planning horizontal approaches to care, primarily addressing the needs of both, the relative with the drinking problem and their AFMs. Keeping in line with this proposed shift of focus, there is scope to explore the relevance of offering 5-Step Method with a supplemented focus on the relative with the drinking problem, as well as other systemic and collaborative approaches to family-based interventions such as the Community Reinforcement and Family Training where family members and their relative with the drinking problem are jointly engaged (Copello et al., Reference Copello, Velleman and Templeton2005).

Fourth, the findings from this pilot RCT corroborated our earlier findings from both our formative work and other work undertaken within India, which is that domestic violence is a major and unresolved problem for many AFMs. Some of this violence is alcohol-related; but some is simply endemic to a culture where violence against women is an accepted and often largely ignored part of the landscape. Further work is needed to create interventions for AFMs which address this wide range of needs and complex situations (Copello et al., Reference Copello, Templeton and Velleman2006). This point leads into a wider implication from this study: how socio-cultural factors influence the impact of interventions. Almost all of our participants were women, who reported experiences which clearly emphasised how patriarchal structures continue to disadvantage them (e.g. the high prevalence of violence). Although the focus of this intervention was on empowerment, it was not uncommon for women to express their needs through the lens of their partners and children, to report multiple burdens as a result of assuming the primary caregiver's role, to report various expressions of violence, and to report poor social support (Church et al., Reference Church, Bhatia, Velleman, Velleman, Orford, Rane and Nadkarni2018; Nadkarni et al., Reference Nadkarni, Bhatia, Velleman, Orford, Velleman, Church, Sawal and Pednekar2019). It is important to note that these experiences are not unique to Goa: previous studies with AFMs have found similar stories, particularly from women (Rey et al., Reference Rey, Mora-Ríos, Sainz and Aguilar2010; Stanley, Reference Stanley2012). This interplay of gender with the experience of being an AFM suggests the need for the inclusion of other perspectives (e.g. a feminist understanding) in planning psychosocial interventions (Orford et al., Reference Orford, Velleman, Copello, Templeton and Ibanga2010b). An example of this feminist approach is from a Mexican qualitative study with AFMs, where female participants experienced positive change in their lives by learning how to change their locus of control (moving from ‘women being objects to subjects of their own destiny’) (Rey et al., Reference Rey, Mora-Ríos, Sainz and Aguilar2010).

Some limitations of our study include one of the ways in which we recruited participants (through self-referrals), which may result in a non-representative sample, as participants who volunteer for a trial may disproportionately possess characteristics related to the outcome. Another important limitation was the reliance on self-reports for outcome evaluation, which introduce an element of subjectivity, and are prone to response bias.

The following characteristics are key strengths of our study. First, we focused on a target population that is considered to be a ‘hidden’ or ‘silent’ and hard-to-reach group. The primary platform through which we recruited our sample was the community, which expanded the potential reach of our study, and improved the representativeness of our sample. Second, to the best of our knowledge, this is the first study that has systematically examined an evidence-based intervention for AFMs ‘in their own right’ in the Indian context. Third, our community-based participatory research approach allowed for a range of community stakeholders to inform the design, conduct and evaluation of the intervention.