TY - JOUR
T1 - 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)
T2 - study protocol for a randomized controlled trial
AU - O'Brien, Rosaleen
AU - Buston, Katie
AU - Wight, Daniel
AU - McGee, Elizabeth
AU - White, Jane
AU - Henderson, Marion
PY - 2019/6/13
Y1 - 2019/6/13
N2 - 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.
AB - 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.
KW - antenatal
KW - early years
KW - maternal mental health
KW - parenting interventions
KW - postnatal
KW - process evaluation
KW - RCT
KW - realist evaluation
KW - vulnerable populations
U2 - 10.1186/s13063-019-3395-3
DO - 10.1186/s13063-019-3395-3
M3 - Article
C2 - 31196169
AN - SCOPUS:85067301520
SN - 1745-6215
VL - 20
JO - Trials
JF - Trials
M1 - 351
ER -