A realist process evaluation of Enhanced Triple P for Baby and Mellow Bumps, within a Trial of Healthy Relationship Initiatives for the Very Early years (THRIVE): study protocol for a randomized controlled trial

Rosaleen O'Brien, Katie Buston, Daniel Wight, Elizabeth McGee, Jane White, Marion Henderson*

*Corresponding author for this work

    Research output: Contribution to journalArticlepeer-review

    9 Citations (Scopus)
    18 Downloads (Pure)

    Abstract

    Background: 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 focuses on THRIVE's realist process evaluation, which is carefully monitoring what is happening in the RCT. Methods: Realistic 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- A nd 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. Discussion: The 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.

    Original languageEnglish
    Article number351
    JournalTrials
    Volume20
    DOIs
    Publication statusPublished - 13 Jun 2019

    Funding

    We are grateful to the National Institute for Health Research Public Health Research Programme (NIHR PHR, project number 11/3002/01) for funding the evaluation and to the CSO and the Scottish Government for funding the intervention costs (GN12KH589 THRIVE). In addition, MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, have supported Dr. Marion Henderson’s use of time regarding THRIVE via MRC/CSO Quinquennial funding of the Relationships and Health Improvement Programme and Settings and Organisation's Programme, which is part of the Social and Public Health Sciences Unit, based at the University of Glasgow, MC_UU_12017_11 and MC_UU12017_12 and CSO SPHSU11 and SPHSU12. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Neither the trial funders nor sponsor (NHS Greater Glasgow & Clyde Health Board) will have any involvement in the implementation of the study design or the analysis of the data.

    Keywords

    • antenatal
    • early years
    • maternal mental health
    • parenting interventions
    • postnatal
    • process evaluation
    • RCT
    • realist evaluation
    • vulnerable populations

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