Abstract

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 CAU alone), 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 = 3 for 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.

Highlights

  • THRIVE 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, 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 describes the planned process evaluation component of a Trial of Healthy Relationship Initiatives for the Very Early years (THRIVE), a three-arm randomised controlled trial (RCT) of two parenting interventions for vulnerable pregnant women

  • THRIVE is investigating whether receiving antenatal and early postnatal parenting interventions, in addition to care as usual (CAU), can improve maternal mental health, mother-infant relationships, and child language development compared with receiving routine antenatal care alone

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Summary

Introduction

THRIVE 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 CAU alone), 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 describes the planned process evaluation component of a Trial of Healthy Relationship Initiatives for the Very Early years (THRIVE), a three-arm randomised controlled trial (RCT) of two parenting interventions for vulnerable pregnant women. THRIVE is investigating whether receiving antenatal and early postnatal parenting interventions, in addition to care as usual (CAU), can improve maternal mental health, mother-infant relationships, and child language development compared with receiving routine antenatal care alone. The publication of protocols for process evaluations has particular utility for researchers who may be aware of recent guidelines for best practice [2] but lack examples of how to design and execute work of this complexity [3]

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