Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial

Henderson, M. et al. (2019) Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial. Trials, 20, 499. (doi:10.1186/s13063-019-3571-5) (PMID:31412902) (PMCID:PMC6694522)

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Abstract

Background: Growing evidence suggests that experiences in the early years play a major role in children’s development in terms of health, wellbeing and educational attainment. The Trial of healthy relationship initiatives for the very early years (THRIVE) aims to evaluate two antenatal group interventions, Enhanced Triple P for Baby and Mellow Bumps, designed for those with additional health or social care needs in pregnancy. As both interventions aim to improve maternal mental health and parenting skills, we hypothesise that in the longer term, participation may lead to an improvement in children’s life trajectories. Methods: THRIVE is a three-arm, longitudinal, randomised controlled trial aiming to recruit 500 pregnant women with additional health or social care needs. Participants will be referred by health and social care professionals, predominately midwives. Consenting participants will be block randomised to one of the three arms: Enhanced Triple P for Baby plus care as usual, Mellow Bumps plus care as usual or care as usual. Groups will commence when participants are between 20 and 34 weeks pregnant. Discussion: The population we aim to recruit are traditionally referred to as “hard to reach”, therefore we will monitor referrals received from maternity and social care pathways and will be open to innovation to boost referral rates. We will set geographically acceptable group locations for participants, to limit challenges we foresee for group participation and retention. We anticipate the results of the trial will help inform policy and practice in supporting women with additional health and social care needs during antenatal and early postnatal periods. This is currently a high priority for the Scottish and UK Governments. Trial registration: International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ISRCTN:21656568. Registered on 28 February 2014 (registered retrospectively (by 3 months)).

Item Type:Articles
Additional Information:Dr Catherine Nixon, Shona Shinwell, Dr Jane White, Karen Crawford, Dr Rosaleen O’Brien, Caoimhe Clarke, Dr Kathleen Boyd and Dr Alice MacLachlan are members of the THRIVE Research Team.
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Clarke, Miss Caoimhe and Wight, Professor Danny and Crawford, Mrs Karen and Thompson, Dr Lucy and McConnachie, Professor Alex and Law, Dr James and Henderson, Dr Marion and Wilson, Dr Philip and McIntosh, Professor Emma and Minnis, Professor Helen and Shinwell, Mrs Shona and Maclachlan, Dr Alice and Nixon, Miss Catherine and O'Dowd, Dr John and White, Mrs Jane and Boyd, Dr Kathleen and O'Brien, Dr Rosaleen and Buston, Dr Katie
Authors: Henderson, M., Wittkowski, A., McIntosh, E., McConnachie, A., Buston, K., Wilson, P., Calam, R., Minnis, H., Thompson, L., O'Dowd, J., Law, J., McGee, E., Wight, D., Nixon, C., Shinwell, S., White, J., Crawford, K., O'Brien, R., Clarke, C., Boyd, K., and MacLachlan, A.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
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 SPHSU
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 20: 499
Publisher Policy:Reproduced under a Creative Commons License
Related URLs:

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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
SPSHU11
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

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