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Published in: Trials 1/2019

Open Access 01-12-2019 | Care | Study protocol

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

Authors: Marion Henderson, Anja Wittkowski, Emma McIntosh, Alex McConnachie, Katie Buston, Philip Wilson, Rachel Calam, Helen Minnis, Lucy Thompson, John O’Dowd, James Law, Elizabeth McGee, Daniel Wight, THRIVE Trial Research Team

Published in: Trials | Issue 1/2019

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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)).
Appendix
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Metadata
Title
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
Authors
Marion Henderson
Anja Wittkowski
Emma McIntosh
Alex McConnachie
Katie Buston
Philip Wilson
Rachel Calam
Helen Minnis
Lucy Thompson
John O’Dowd
James Law
Elizabeth McGee
Daniel Wight
THRIVE Trial Research Team
Publication date
01-12-2019
Publisher
BioMed Central
Keyword
Care
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3571-5

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