Parental determinism is a term coined by sociologist Frank Furedi to describe and critique an argument directly associating parents’ quotidian behaviour with their children’s outcomes and therefore, the future of society. This study involved qualitative interviews with 22 mothers living in Scotland to examine their views about the ideals of parental determinism and suggest possible factors explaining the varying endorsement. Of the mothers who more highly endorsed parental determinism, several reported poor experiences of being parented themselves. All the mothers of autistic children expressed some critique of the idea that parental action is solely responsible for children’s outcomes. The former variance may be due to perceived links between their own childhood experiences and later mental health issues, and the latter due to their children not responding to parental action as expected. These factors may highlight and minimise the perceived importance, to the mothers, of parenting behaviours.

Background:Women who have additional social and care needs in pregnancy (e.g. social adversity, maternal depression and anxiety) are likely to produce high levels of stress hormones. This has the potential to affect fetal brain development, increase infant reactivity to stress, and impair sensitive mother-infant bonds from developing. These in turn may have long-term effects on children's health, social and educational outcomes. Parenting interventions show promising improvements to child outcomes; however, there is little evidence of their efficacy in the UK. Objective(s):THRIVE compared the impact of taking part in one of two antenatal parenting support programmes both incorporating cognitive-behavioural therapy (Enhanced Triple P for Baby or Mellow Bumps) with care-as-usual alone on the mental health and maternal attunement of vulnerable mothers-to-be, as well as the socioemotional and behavioural development of their children. Design:THRIVE is a three-arm randomised controlled trial. Pregnant women with additional social and care needs in pregnancies were invited to participate. Participants were randomly allocated to Enhanced Triple P for Baby, Mellow Bumps or care-as-usual. Setting:The study took place in National Health Service Greater Glasgow and Clyde and National Health Service Ayrshire and Arran health board areas. Intervention sessions were predominantly in community settings. Participants:Women identified as having additional social and care needs in pregnancies during pregnancy based on the National Health Service Greater Glasgow and Clyde's Special Needs in Pregnancy criteria were recruited to THRIVE (n = 485), slightly below the target of 500 women. Participants were block-randomised 5 : 5 : 2 to Enhanced Triple P for Baby, Mellow Bumps or care-as-usual. Subsequently their babies and accompanying person of choice were also invited. Interventions:Enhanced Triple P for Baby consists of four weekly group-based antenatal sessions followed by up to three postnatal home visits and one postnatal group session. It aims to provide babies with a healthy start to life by combining parenting skills training with strategies to enhance individual well-being and couple adjustment. Mellow Bumps in comparison, comprises of seven weekly antenatal sessions and one postnatal session. It aims to decrease maternal stress, increase understanding of neonates' capacity for social interaction, and emphasise the importance of early interaction for brain development and attachment. Recruitment to the trial took place between early 2014 and May 2018. Main outcome measures:Our two primary outcomes were the Hospital Anxiety and Depression Scale, plus outwardly directed irritability from the Adult Wellbeing Scale, and CARE Index mother-infant dyadic interaction synchrony. Results:There were no significant differences in the change from baseline in Hospital Anxiety and Depression Scale and outwardly expressed irritability score between the combined active intervention groups and care-as-usual only [effect size (95% confidence interval) 0.03 (-0.24 to 0.29)], or between either Enhanced Triple P for Baby and Care-as-usual only [0.04 (-0.24 to 0.32)] or Mellow Bumps and care-as-usual only [0.01 (-0.27 to 0.30)]. Mellow Bumps holds promise for cost-effectiveness due to its potential for cost-savings relating to routine healthcare resource use. Limitations:The main limitation of THRIVE was poor attendance of the groups (under 42%) offered to our Enhanced Triple P for Baby and Mellow Bumps participants. However, subgroup analysis adjusted for level of attendance suggested the results would not have been any different with increased participation. Conclusions:With the population THRIVE involved, at a stage of pregnancy when a lot of support is offered (with many parenting interventions being offered without rigorous evaluation), we do not have evidence to recommend the rollout of Enhanced Triple P for Baby or Mellow Bumps. Future work:Future work could explore the timing and intensity of interventions, intervention group composition, co-produced programmes, online sessions, and impact of addressing inequalities. Trial registration:This trial is registered as Current Controlled Trials ISRCTN21656568 (www.isrctn.com/ISRCTN21656568). Funding:This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref. 11/3002/01) and is published in full in Public Health Research; Vol. 13, No. 4. See the NIHR Funding and Awards website for further award information.

Despite almost a century’s research capacity strengthening in Africa, HIV/AIDS research has been dominated by high-income countries (HICs), illustrating broader inequalities in the global knowledge economy. The perpetuation of weak social science capacity in east Africa is analysed as part of a complex system with multiple causes at different socio-ecological levels. Furthermore, although primarily driven by HIC/ neo-colonialist interests, causes also stem from low-income countries (LICs), and individual actions reproduce macro-level structures. Most factors link to global economic inequalities, and the extraction of data and intellectual capacity from east Africa operates akin to Dependency Theory, but this is exacerbated by African governments. At the meso-level, HIC institutions prioritise revenue and publications over strengthening LIC research capacity, whatever their rhetoric, while serious impediments exist in east African institutions. At the micro-level, HIC researchers perpetuate inequalities through, e.g., prioritising output, maintaining dependency, and choosing HIC rather than LIC conferences and journals. Multiple responses are needed, particularly at the macro-level, especially long-term, tailored funding. Meso-level responses include meritocratic career structures and institutional research consultancies. Individual HIC researchers should, ideally, prioritise training and mentoring, but this risks career advancement. Above all, honesty is required about motives and conflicting interests, at institutional and individual levels.

Online delivery of community music groups has become more widely accepted following the COVID-19 pandemic, and may reduce barriers to attendance for certain demographics, including mothers with caring responsibilities. However, different interaction patterns may affect group processes, altering a programme’s underlying mechanisms of change when adapted for online delivery. This research compares in-person and videoconference delivery of the Lullaby Project, a therapeutic community music group for mothers with infants aged under 3. It explores engagement, participation and group processes, and elucidates the mechanisms of change for both modes of implementation. Semi-structured interviews were conducted with nine mothers and seven musicians who had experienced one of three delivery methods: (1) face-to-face; (2) face-to-face and online combination and (3) online. Interviews were analysed inductively using thematic analysis and eleven sub-themes were identified within three overarching themes: (1) engagement; (2) group processes and (3) change mechanisms. Mothers perceived benefits and formed meaningful relationships in-person and online, although the distinct group processes and change mechanisms suggest the delivery methods constitute distinct interventions. Specifically, relationships were formed on an individual level during in-person delivery, whereas group-based connections were more likely with online delivery. Further research is needed to explore a diversity of experiences, and to evaluate the efficacy of online delivery of community music groups.

IntroductionThe role of the group has been largely overlooked within evaluations of group-based parenting programmes. Group contextual factors, including size and level of homogeneity, may impact on essential group processes, such as group identification and cohesion, that are necessary to activate interpersonal change mechanisms and attain programme outcomes. This process evaluation of Mellow Babies, a 14-week attachment-based group parenting programme for mothers of infants aged under 18 months, explores how group context affected mother and practitioner experiences of the programme.MethodsIn-depth interviews were conducted with fourteen mothers and three practitioners from three different Mellow Babies groups. Framework Analysis was employed to analyse data, using groups as cases within the framework matrix while preserving individual participants within each case. This allowed comparisons to be made within and between groups.ResultsFour group contextual factors impacted on the quality of programme delivery: (1) group size; (2) level of group homogeneity; (3) pre-existing relationships; and (4) personalities within the group. These contextual factors affected the hypothesised intervention mechanisms: (1) fluid progression through the stages of group development; (2) a safe, non-judgemental, contained space; (3) social identification with group; (4) group cohesion; and (5) a culture of openness, support and empowerment.DiscussionFindings have implications for future delivery and implementation of group-based parenting programmes, for example, the importance of considering group composition during programme recruitment. Practitioners may also benefit from a stronger focus on group processes and enabling group dynamics within training, supervision, and the programme manual.

Background There is a growing need for interventions that reduce both violence against children and intimate partner violence in low- and middle-income countries. However, few parenting interventions deliberately address this link. We tested the feasibility of a 16-session group-based parenting programme, Parenting for Respectability, in semi-rural Ugandan communities. Methods This was a pre-post study with parents and their children (N = 484 parents; 212 children). Results Pre-post comparisons found large effects for parent-reported reduced harsh parenting (Cohen’s f2 = 0.41 overall; f2 = 0.47 (among session attendees); with an overall reduction of 26% for harsh parenting. Session attendees reported higher reductions than non-attendees (p = 0.014), and male caregivers reported higher reductions than female caregivers (p<0.001). Children also reported reduced harsh parenting by attending fathers (f2 = 0.64 overall; f2 = 0.60) and attending mothers (f2 = 0.56 overall; f2 = 0.51); with reduction in harsh parenting ranging between 27% to 29% in the various categories. Overall, spousal violence reduced by 27% (f2 = 0.19 overall; f2 = 0.26 (among session attendees). Both parents and children reported reduced dysfunctional parent relationships; parents: f2 = 0.19 overall; f2 = 0.26 (among session attendees); and children: f2 = 0.35 overall; f2 = 0.32 (for attending parents); with reductions ranging between 22% to 28%. Parents who attended more than 50% of the program reported greater effects on reduced dysfunctional relationships than those who attended less than half of the program (B = -0.74, p = 0.013). All secondary outcomes were improved with f2 ranging between 0.08 and 0.39; and improvements ranging between 6% and 28%. Conclusion Results suggest the importance of more rigorous testing to determine program effectiveness.

Background Stronger social and emotional well-being during primary school is positively associated with the health and educational outcomes of young people. However, there is little evidence on which programmes are the most effective for improving social and emotional well-being. Objective The objective was to rigorously evaluate the Social and Emotional Education and Development (SEED) intervention process for improving pupils’ social and emotional well-being. Design This was a stratified cluster randomised controlled trial with embedded process and economic evaluations. Thirty-eight primary schools were randomly assigned to the SEED intervention or to the control group. Hierarchical regression analysis allowing for clustering at school learning community level was conducted in R (statistical package). Setting The SEED intervention is a whole-school intervention; it involved all school staff and two cohorts of pupils, one starting at 4 or 5 years of age and the second starting at 8 or 9 years of age, across all 38 schools. Participants A total of 2639 pupils in Scotland. Intervention The SEED intervention used an iterative process that involved three components to facilitate selection and implementation of school-based actions: (1) questionnaire completion, (2) benchmarked feedback to all staff and (3) reflective discussions (all staff and an educational psychologist). Main outcome measure The primary outcome was pupils’ Strengths and Difficulties Questionnaire-Total Difficulties Score when pupils were 4 years older than at baseline. Results The primary outcome, pupils’ Strengths and Difficulties Questionnaire-Total Difficulties Score at follow-up 3, showed improvements for intervention arm pupils, compared with those in the control arm [relative risk −1.30 (95% confidence interval −1.87 to −0.73), standardised effect size −0.27 (95% confidence interval −0.39 to −0.15)]. There was no evidence of intervention effects according to deprivation: the results were significant for both affluent and deprived pupils. Subgroup analysis showed that all effect sizes were larger for the older cohort, particularly boys [relative risk −2.36 (95% confidence interval −3.62 to −1.11), standardised effect size −0.42 (95% confidence interval −0.64 to −0.20)]. Although there was no statistically significant difference in incremental cost and quality-adjusted life-years, the probability that the intervention is cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year was high, at 88%. Particularly valued mechanisms of the SEED intervention were its provision of time to reflect on and discuss social and emotional well-being and its contribution to a culture of evaluating practice. Limitations It was a challenge to retain schools over five waves of data collection. Conclusions This trial demonstrated that the SEED intervention is an acceptable, cost-effective way to modestly improve pupil well-being and improve school climate, particularly for older boys and those with greater levels of psychological difficulties. It was beneficial during the transition from primary to secondary school, but this diminished after 6 years. The SEED intervention can be implemented alongside existing systems for addressing pupil well-being and can be complementary to other interventions. Future work Assess whether or not the SEED intervention has a beneficial impact on academic attainment, is transferable to other countries and other organisational settings, would be strengthened by adding core training elements to the intervention process and is transferable to secondary schools. Understand the gender differences illustrated by the outcomes of this trial. Conduct further statistical research on how to handle missing data in longitudinal studies of complex social interventions. Trial registration This trial is registered as ISRCTN51707384. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 10/3006/13) and is published in full in Public Health Research ; Vol. 12, No. 6. See the NIHR Funding and Awards website for further award information.

IntroductionGroup-based parenting programmes have specific mechanisms of change compared to individual delivery. The Mechanisms of Action in Group-based Interventions framework (MAGI); distinguishes between interpersonal and intrapersonal mechanisms of change. This paper articulates a theory of change for Mellow Babies, a 14-week attachment-based group parenting programme for mothers of infants aged under 18 months, identifying the inter and intrapersonal change processes.MethodsThirty-two semi-structured interviews were conducted with mothers and practitioners who participated in Mellow Babies, including twenty post-group interviews and nine telephone fidelity checks. Data were analysed using Deductive Qualitative Analysis based on the components identified within the MAGI framework.ResultsKey interpersonal change mechanisms included: 1. Normalisation through social comparisons; 2. Validation and cognitive reframing through group feedback; 3. Peer support, offering accountability for the implementation of new habits, and providing opportunities to give and receive advice; and 4. Social and experiential learning, including internalisation of group responses leading to increased self-compassion. Intrapersonal change mechanisms were: 1. Developing new self-insight, including parenting self-awareness; 2. Increasing parenting knowledge and understanding of infant development; 3. Having time and space for self; 4. Motivation to implement new habits. Interpersonal change mechanisms had a moderating role on intrapersonal change mechanisms and subsequent programme outcomes.DiscussionThe contribution of group processes and interpersonal mechanisms of change are often overlooked within programme evaluations. Findings from this study implicate their mediating role on intrapersonal change mechanisms and subsequent programme outcomes. It is important for programme deliverers and evaluators to understand the interrelationships between group processes, change mechanisms and programme outcomes to optimise efficacy and ensure cross-contextual replicability.

Background:Having a good start in life during pregnancy and infancy has been shown to be important for living both a healthy life and a longer life. Despite the introduction of many policies for the early-years age group, including voucher schemes, with the aim of improving nutrition, there is limited evidence of their impact on health. Objectives:To assess the effectiveness of the Healthy Start voucher scheme on infant, child and maternal outcomes, and to capture the lived experiences of the Healthy Start voucher scheme for low-income women. Design:This was a natural experiment study using existing data sets, linked to routinely collected health data sets, with a nested qualitative study of low-income women and an assessment of the health economics. Setting:Representative sample of Scottish children and UK children. Participants:Growing Up in Scotland cohort 2 (n = 2240), respondents to the 2015 Infant Feeding Study (n = 8067) and a sample of 40 participants in the qualitative study. Interventions:The Health Start voucher, a means-tested scheme that provides vouchers worth £3.10 per week to spend on liquid milk, formula milk, fruit and vegetables. Main outcome measures:Infant and child outcomes - breastfeeding initiation and duration; maternal outcomes - vitamin use pre and during pregnancy. Results:The exposed group were women receiving the Healthy Start voucher (R), with two control groups: eligible and not claiming the Healthy Start voucher (E) and nearly eligible. There was no difference in vitamin use during pregnancy for either comparison (receiving the Healthy Start voucher, 82%; eligible and not claiming the Healthy Start voucher, 86%; p = 0.10 vs. receiving the Healthy Start voucher, 87%; nearly eligible, 88%; p = 0.43) in the Growing Up in Scotland cohort. Proportions were similar for the Infant Feeding Study cohort (receiving the Healthy Start voucher, 89%; eligible and not claiming the Healthy Start voucher, 86%; p = 0.01 vs. receiving the Healthy Start voucher, 89%; nearly eligible, 87%; p = 0.01); although results were statistically significantly different, these were small effect sizes. There was no difference for either comparison in breastfeeding initiation or breastfeeding duration in months in Growing Up in Scotland, but there was a negative effect of the Healthy Start voucher in the Infant Feeding Survey. This contrast between data sets indicates that results are inconclusive for breastfeeding. The qualitative study found that despite the low monetary value the women valued the Healthy Start voucher scheme. However, the broader lives of low-income women are crucial to understand the constraints to offer a healthy diet. Limitations:Owing to the policy being in place, it was difficult to identify appropriate control groups using existing data sources, especially in the Infant Feeding Study. Conclusions:As the Healthy Start voucher scheme attempts to influence health behaviour, this evaluation can inform other policies aiming to change behaviour and use voucher incentives. The null effect of Healthy Start vouchers on the primary outcomes may be due to the value of the vouchers being insufficient to change the broader lives of low-income women to offer a healthy diet. Future work:The methods developed to undertake an economic evaluation alongside a natural experiment using existing data can be used to explore the cost-effectiveness of the Healthy Start voucher scheme. Funding:This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 11, No. 11. See the NIHR Journals Library website for further project information.

Innovation in addiction recovery in Scotland includes the transfer of effective models from other countries, such as San Patrignano, Italy and Basta, Sweden. Independence from Drugs and Alcohol Scotland (IFDAS) was founded to develop a new model for Scotland, based on social enterprise. Drawing on the San Patrignano programme theory, this prospective study investigates IFDAS stakeholders' perspectives on which mechanisms should be transferred, and which require adaptation of the delivery mode, for the Scottish context. Data collection included interviews with ten stakeholders with expertise including: drugs policy, social enterprise, alcohol and drug partnership practice and therapeutic community methods. Drawing on realist principles, data were analysed using inductive and deductive approaches and synthesised using frameworks. San Patrignano mechanisms identified for transfer include: the need for motivation, recovery peer mentors, visionary leadership and social enterprise. Adaptations from Basta include: extending abstinence to alcohol and creating a smaller, semi-permeable, residential community. Further adaptations to mechanism delivery include a 'step-wise' model of housing and work. Scottish contextual factors shaping adaptations include: the culture of alcohol misuse, social care standards, housing regulations and socio-cultural acceptability. This study contributes to the evidence on international transfer and adaptation of complex interventions and documents stakeholders' theory-informed decision making in the development of a new Scottish recovery model.

Purpose: To develop a culturally-sensitive intervention for the early prevention of gender-based violence (GBV) in Uganda. Methods: Programme design followed the 6SQuID model of intervention development and multi-sectorial advice. A formative evaluation was conducted in two communities with six groups and 138 participants. Findings: Four familial predictors of GBV were identified as potentially malleable: poor parent-child attachment, harsh parenting, inequitable gendered socialization and parental conflict. A community-based parenting programme was developed to address them. Its programme theory incorporates Attachment Theory, the concept that positive behavioural control develops emotional control, and Social Learning Theory. Its rationale, structure and content are presented using the TIDieR checklist. A formative evaluation showed the programme to be widely acceptable, culturally appropriate, and perceived to be effective, but also identified challenges. Conclusion: The careful development of this community-based parenting programme shows promise for the early prevention of GBV.

Interventions tackling zoonoses require an understanding of healthcare patterns related to both human and animal hosts. The control of dog-mediated rabies is a good example. Despite the availability of effective control measures, 59,000 people die of rabies every year worldwide. In Tanzania, children are most at risk, contributing ~40% of deaths. Mass dog vaccination can break the transmission cycle, but reaching the recommended 70% coverage is challenging where vaccination depends on willingness to vaccinate dogs. Awareness campaigns in communities often target children, but do not consider other key individuals in the prevention chain. Understanding factors related to dog ownership and household-level responsibility for dog vaccination and child health is critical to the design of vaccination strategies. We investigated who makes household decisions about dogs and on health care for children in rural Tanzania. In the Kilosa district, in-depth interviews with 10 key informants were conducted to inform analysis of data from a household survey of 799 households and a survey on Knowledge Attitudes and Practices of 417 households. The in-depth interviews were analysed using framework analysis. Descriptive analysis showed responsibilities for household decisions on dogs’ and children’s health. Multivariate analysis determined factors associated with the probability of dogs being owned and the number of dogs owned, as well as factors associated with the responsibility for child health. Dog ownership varied considerably between villages and even households. The number of dogs per household was associated with the size of a household and the presence of livestock. Children are not directly involved in the decision to vaccinate a dog, which is largely made by the father, while responsibility for seeking health care if a child is bitten lies with the mother. These novel results are relevant for the design and implementation of rabies interventions. Specifically, awareness campaigns should focus on decision-makers in households to improve rabies prevention practices and on the understanding of processes critical to the control of zoonoses more broadly.

The San Patrignano drug recovery community, Italy, is regarded as one of the most successful in the world. However, if this model is to be transferred to other countries, it is necessary to clarify its underlying mechanisms and how far their success is context dependent. This qualitative study investigated these features of the San Patrignano model. Data collection included semi-structured interviews with six key stakeholders and 10 days' observational field notes. Data were synthesised using frameworks and analysis was informed by realist principles. Individual level mechanisms include: commitment to change, removal from former social environment, communal living, peer mentor with lived experience and meaningful work. These operate in the context of a free of charge, long term (3-4 year) residential community. Organisational level mechanisms are: visionary leadership, staff dedication, social enterprise and adaptable learning. Organisational contextual factors include: a gap in suitable provision for drug recovery and the region's high level of social capital. Articulating the programme theory of the recovery model and its contextual dependency helps clarify which elements should be transferred and how far they need to be adapted for different socio-cultural settings. The recognition of context is crucial when considering transfer of effective complex interventions across countries.

AIM:To understand how the social networks of a new recovery community can help sustain recovery, focusing on processes of social identity change, in the context of the wider UK recovery movement.METHODS:A cross-sectional, mixed-methods social network analysis (SNA) of ego-network sociograms to map network transitions, using retrospective measures. Ten men were recruited from a peer-worker programme, in the South Ayrshire Alcohol and Drug Partnership (ADP), West of Scotland. Network measures were compared between two timepoints, just prior to current recovery and the present time. Measures included size and density, closeness of members, and their positive or negative influence, proportion of alcohol and other drug (AOD) using and recovery peers, and extent of separate subgroups. These were complemented with qualitative interview data.FINDINGS:There was a significant transition in network composition, with the replacing of AOD-using peers with recovery peers and a broader transformation from relationships being framed as negative to positive. However, there was no significant transition in network structure, with AOD-using and recovery networks both consisting of strong ties and a similar density of connections between people in the networks.CONCLUSIONS:The transition in network composition between pre-recovery and the present indicates a different set of social influences, while the similarities in network structure indicate that the recovery network replaced the role of the using network in providing close bonds. This helped reduce social isolation experienced in early-recovery and provided a pathway into more structured opportunities for volunteering and employment.

Background: Parenting programmes may reduce risk of violence against children and improve child wellbeing. However, additional economic support may be necessary in highly-deprived low-income countries.Methods: A parallel cluster randomised controlled trial examined the combined and separate effects of parenting and economic strengthening on reducing violence against children ages 0 to 18 years in impoverished farming communities in Tanzania (N =248 families). Eight villages were randomly assigned to four conditions (2:2:2:2 ratio): 1) 12-session parenting programme (N =60); 2) agribusiness training (N =56); 3) parenting and agribusiness combined (N =72); 4) control (N =60). Parent-report, child-report, and early childhood observation assessments were conducted at baseline, mid-treatment, and post-treatment. Primary outcomes included child maltreatment, parenting behaviour, and corporal punishment endorsement. Secondary outcomes included parenting stress, parent/child depression, child behaviour, economic wellbeing, and child development (ClinicalTrials.gov: NCT02633319). Assessors were blind to allocation status at baseline; the data analyst was also blind to allocation until after initial intention-to-treat analyses.Findings: At post-treatment, parents and children receiving the combined interventions reported less maltreatment (parents: IRR=0.40, 95%CI [0.24,0.65]; children: IRR=0.40, 95%CI [0.17,0.92]). Parents also reported reduced endorsement of corporal punishment (Dw =-0.43, 95%CI [-0.79,0.07]), and less child behaviour problems (Dw =-0.41, 95%CI [-0.77,-0.05]). Parents in parenting-only villages reported less abuse (IRR=0.36, 95%CI [0.21,0.63]) and less child behaviour problems (Dw =-0.47, 95%CI [-0.84,-0.11]). Parents in agribusiness-only villages reported less child behaviour problems (Dw =-0.43, 95%CI [-0.77,-0.08]) and greater household wealth (Dw =0.57, 95%CI [0.08,1.06]). However, children in agribusiness-only villages reported increased physical abuse (IRR=2.26, 95%CI [1.00,5.12]) and less positive parenting (Dw =-0.50, 95%CI [-0.91,-0.10]). There were no other adverse effects.Interpretation: Results suggest that the parenting component may be the active ingredient in reducing maltreatment, and that agribusiness training programmes may have unintended negative consequences on children when delivered alone.Trial Registration: (ClinicalTrials.gov: NCT02633319; Pan African Clinical Trials: PACTR201610001267268).Funding Statement: The Skilful Parenting and Agribusiness Child Abuse Prevention Study (SPACAPS) was supported by the UBS Optimus Foundation (Grant: 7849.09), the Netherlands Ministry of Foreign Affairs, and the Complexity in Health Improvement Programme of the Medical Research Council MRC UK (Grant: MC_UU_12017/14).Declaration of Interests: The authors declare no competing interests.Ethics Approval Statement: Ethical approval was received from the Tanzania Lake Zone Institutional Review Board (03.09.2015) and the University of Oxford Social Sciences and Humanities Interdivisional Research Ethics Committee (SSD/CUREC1A/14-SSH_C2_15_023).

Introduction Parenting programmes may reduce the risk of violence against children and improve child well-being. However, additional economic support may be necessary in highly deprived rural communities in sub-Saharan Africa. Furthermore, delivering programmes within farmer groups may increase male caregiver recruitment and engagement.Methods A parallel cluster randomised controlled trial examined the combined and separate effects of parenting and economic strengthening programmes on reducing violence against children aged 0–18 years in farming communities in Tanzania (n=248 families; 63% male caregivers). Eight villages were randomly assigned to four conditions (2:2:2:2): (1) 12-session parenting programme (n=60); (2) agribusiness training (n=56); (3) parenting and agribusiness combined (n=72); (4) control (n=60). Parent-report, child-report and early childhood observation assessments were conducted at baseline, mid-treatment and post-treatment. Primary outcomes were child maltreatment and parenting behaviour. Secondary outcomes included corporal punishment endorsement, parenting stress, parent/child depression, child behaviour, economic well-being and child development.Results At post-treatment, parents and children receiving the combined interventions reported less maltreatment (parents: incidence rate ratio (IRR=0.40, 95% CI 0.24 to 0.65; children: IRR=0.40, 95% CI 0.17 to 0.92). Parents reported reduced endorsement of corporal punishment (Dw=−0.43, 95% CI −0.79 to 0.07) and fewer child behaviour problems (Dw=−0.41, 95% CI −0.77 to 0.05). Parents in parenting-only villages reported less abuse (IRR=0.36, 95% CI 0.21 to 0.63) and fewer child behaviour problems (Dw=−0.47, 95% CI −0.84 to 0.11). Parents in agribusiness-only villages reported fewer child behaviour problems (Dw=−0.43, 95% CI −0.77 to 0.08) and greater household wealth (Dw=0.57, 95% CI 0.08 to 1.06). However, children in agribusiness-only villages reported increased physical abuse (IRR=2.26, 95% CI 1.00 to 5.12) and less positive parenting (Dw=−0.50, 95% CI −0.91 to 0.10). There were no other adverse effects.Conclusion Parent training may be the active ingredient in reducing maltreatment in farmer groups with majority male caregivers, while agribusiness training programmes may have unintended negative consequences on children when delivered alone. Locating parenting support in existing farmer groups can engage much higher proportions of fathers than stand-alone programmes.ClinicalTrials.gov: NCT02633319

Background: Growing evidence suggests that experiences in the early years play a major role in children’s development in terms of health, wellbeing and educational attainment. The Trial of healthy relationship initiatives for the very early years (THRIVE) aims to evaluate two antenatal group interventions, Enhanced Triple P for Baby and Mellow Bumps, designed for those with additional health or social care needs in pregnancy. As both interventions aim to improve maternal mental health and parenting skills, we hypothesise that in the longer term, participation may lead to an improvement in children’s life trajectories. Methods: THRIVE is a three-arm, longitudinal, randomised controlled trial aiming to recruit 500 pregnant women with additional health or social care needs. Participants will be referred by health and social care professionals, predominately midwives. Consenting participants will be block randomised to one of the three arms: Enhanced Triple P for Baby plus care as usual, Mellow Bumps plus care as usual or care as usual. Groups will commence when participants are between 20 and 34 weeks pregnant. Discussion: The population we aim to recruit are traditionally referred to as “hard to reach”, therefore we will monitor referrals received from maternity and social care pathways and will be open to innovation to boost referral rates. We will set geographically acceptable group locations for participants, to limit challenges we foresee for group participation and retention. We anticipate the results of the trial will help inform policy and practice in supporting women with additional health and social care needs during antenatal and early postnatal periods. This is currently a high priority for the Scottish and UK Governments. (Continued on next page) © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. * Correspondence: Marion.Henderson@glasgow.ac.uk Medical Research Council/Chief Scientist Office Social and Public Health Sciences Unit, University of Glasgow, Top Floor 200 Renfield Street, Glasgow G2 3AX, Scotland Full list of author information is available at the end of the article Henderson et al. Trials (2019) 20:499 https://doi.org/10.1186/s13063-019-3571-5

BackgroundSurveys of young people under-represent those in alternative education settings (AES), potentially disguising health inequalities. We present the first quantitative UK evidence of health inequalities between AES and mainstream education school (MES) pupils, assessing whether observed inequalities are attributable to socioeconomic, familial, educational and peer factors.MethodsCross-sectional, self-reported data on individual- and poly-substance use (PSU: combined tobacco, alcohol and cannabis use) and sexual risk-taking from 219 pupils in AES (mean age 15.9years) were compared with data from 4024 pupils in MES (mean age 15.5years). Data were collected from 2008 to 2009 as part of the quasi-experimental evaluation of Healthy Respect 2 (HR2).ResultsAES pupils reported higher levels of substance use, including tobacco use, weekly drunkenness, using cannabis at least once a week and engaging in PSU at least once a week. AES pupils also reported higher levels of sexual health risk behaviours than their MES counterparts, including: earlier sexual activity; less protection against sexually transmitted infections (STIs); and having 3+ lifetime sexual partners. In multivariate analyses, inequalities in sexual risk-taking were fully explained after adjusting for higher deprivation, lower parental monitoring, lower parent-child connectedness, school disengagement and heightened intentions towards early parenthood among AES vs MES pupils. However, an increased risk (OR=1.73, 95% CI 1.15, 2.60) of weekly PSU was found for AES vs MES pupils after adjusting for these factors and the influence of peer behaviours.ConclusionAES pupils are more likely to engage in health risk behaviours, including PSU and sexual risk-taking, compared with MES pupils. AES pupils are a vulnerable group who may not be easily targeted by conventional population-level public health programmes. Health promotion interventions need to be tailored and contextualised for AES pupils, in particular for sexual health and PSU. These could be included within interventions designed to promote broader outcomes such as mental wellbeing, educational engagement, raise future aspirations and promote resilience.

BackgroundTHRIVE is a three-arm randomised controlled trial (RCT)that aims to evaluate whether antenatal and early postnatal interventions, Enhanced Triple B for Baby (ETPB) plus care as usual (CAU) or Mellow Bumps (MB) plus CAU (versus CAUalone), can: 1) improve the mental health and well-being of pregnant women with complex health and social care needs; 2) improve mother-infant bonding and interaction; 3) reduce child maltreatment; and 4) improve child language acquisition. This paper focuses on THRIVE's realist process evaluation, which is carefully monitoring what is happening in the RCT.MethodsRealistic evaluation provides the theoretical rationale for the process evaluation. We question: 1) how faithfully are MB and ETPB implemented? 2) What are the mechanisms by which they work, if they do, and who do they work for and how? 3) What contextual factors are necessary for the programmes to function, or might prevent them functioning?The mixed-methods design includes quantitative measures, which are pre- and post-training/intervention questionnaires for facilitators and mothers-to-be, and post-session evaluation forms. Qualitative data collection methods include participant observation of facilitator training and the delivery of a series of antenatal sessions in selected intervention groups (n=3 for ETPB and n=3for MB), semi-structured interviews with facilitators, pregnant women, partners, and referring facilitators, and telephone interviews examining the content of the postnatal components of ETPB and MB.DiscussionThe findings of this process evaluation will help researchers and decision makers interpret the outcomes of THRIVE. It will provide a greater understanding of: how the interventions work (if they do); the extent and quality of their implementation; contextual factors facilitating and constraining intervention functioning; variations in response within and between subgroups of vulnerable parents; and benefits or unintended consequences of either intervention. Few studies to date have published detailed research protocols illustrating how realist process evaluation is designed and conducted as an integral part of a randomised controlled trial.Trial registrationISRCTN, ISRCTN21656568. Registered on 8 November 2013.