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

O'Brien, R., Buston, K. , Wight, D. , McGee, E., White, J. and Henderson, M. (2019) 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. Trials, 20, 351. (doi:10.1186/s13063-019-3395-3) (PMID:31196169)

[img]
Preview
Text
161102.pdf - Published Version
Available under License Creative Commons Attribution.

1MB

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- 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. 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.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Wight, Professor Daniel and Henderson, Dr Marion and White, Mrs Jane and O'Brien, Dr Rosaleen and Buston, Dr Katie
Authors: O'Brien, R., Buston, K., Wight, D., McGee, E., White, J., and Henderson, M.
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > General Practice and Primary Care
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Health Economics and Health Technology Assessment
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > MRC/CSO Unit
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Mental Health and Wellbeing
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Robertson Centre
Journal Name:Trials
Publisher:BioMed Central
ISSN:1745-6215
ISSN (Online):1745-6215
Copyright Holders:Copyright © 2019 The Authors
First Published:First published in Trials 30:351
Publisher Policy:Reproduced under a Creative Commons License

University Staff: Request a correction | Enlighten Editors: Update this record

Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
727631SPHSU Core Renewal: Relationships & Health Improvement Research ProgrammeLisa McDaidMedical Research Council (MRC)MC_UU_12017/11IHW - MRC/CSO SPHU
578663Trial of Healthy Relationship Initiatives for the Very Early-years (THRIVE): a Three-Arm Randomised Control Trial for Mothers Identified as Vulnerable in Pregnancy and their Babies who are at High...Marion HendersonNational Institute for Health Research (NIHR)11/3002/01IHW - MRC/CSO SPHU
SPHSU11