Evaluation of parenting interventions for those with additional health and social care needs during pregnancy: THRIVE a multi-arm RCT with embedded economic and process components.

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.