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

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 BabyandMellow 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:EnhancedTriple P for Babyplus care as usual,Mellow Bumpsplus care as usual or care as usual. Groups will commence whenparticipants are between 20 and 34 weeks pregnant.Discussion:The population we aim to recruit are traditionally referred to as“hard to reach”, therefore we willmonitor referrals received from maternity and social care pathways and will be open to innovation to boost referralrates. We will set geographically acceptable group locations for participants, to limit challenges we foresee for groupparticipation and retention. We anticipate the results of the trial will help inform policy and practice in supportingwomen with additional health and social care needs during antenatal and early postnatal periods. This is currently ahigh 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)).