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

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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

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)).
Original languageEnglish
Article number557
JournalTrials
Volume20
Issue number1
DOIs
Publication statusPublished - 14 Aug 2019

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this