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

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[1] 0000 0000 9975 243X, grid.451092.b, NHS Ayrshire and Arran, Afton House, Ailsa Hospital Campus, Dalmellington Road, KA6 6AB, Ayr, Scotland;0000 0001 0462 7212, grid.1006.7, Institute of Health and Society, School of Education, Communication and Language Sciences, University of Newcastle, NE1 7RU, Newcastle-upon-Tyne, England;0000 0001 0669 8188, grid.5214.2, Parenting and Family Support Research Programme, Department of Psychology and Allied Health Sciences, School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, G4 0BA, Glasgow, Scotland;0000 0001 2193 314X, grid.8756.c, Health Economics and Health Technology Assessment, University of Glasgow, G12 8QQ, Glasgow, Scotland;0000 0001 2193 314X, grid.8756.c, Medical Research Council/Chief Scientist Office Social and Public Health Sciences Unit, University of Glasgow, Top Floor 200 Renfield Street, G2 3AX, Glasgow, Scotland;0000 0001 2193 314X, grid.8756.c, Robertson Centre for Biostatistics, Boyd Orr Building, University of Glasgow, G12 8QQ, Glasgow, Scotland;0000 0004 1936 7291, grid.7107.1, Centre for Rural Health, University of Aberdeen, The Centre for Health Science, Old Perth Road, IV2 3JH, Inverness, Scotland;0000 0004 1936 7291, grid.7107.1, Centre for Rural Health, University of Aberdeen, The Centre for Health Science, Old Perth Road, IV2 3JH, Inverness, Scotland;Institute of Health and Wellbeing, University of Glasgow, Caledonia House, Royal Hospital for Sick Children, Yorkhill, G3 8SJ, Glasgow, Scotland;0000000121662407, grid.5379.8, Division of Psychology and Mental Health, School of Health Sciences, The University of Manchester, 2nd Floor Zochonis Building, Brunswick Street, M13 9PL, Manchester, England;Institute of Health and Wellbeing, University of Glasgow, Caledonia House, Royal Hospital for Sick Children, Yorkhill, G3 8SJ, Glasgow, Scotland;

关键词: Mothers;    Parenting interventions;    Pregnancy;    Maternal mental health;    Perinatal mental health;    Hard to reach populations;   

DOI  :  10.1186/s13063-019-3571-5

来源: publisher

【 摘 要 】

BackgroundGrowing 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.MethodsTHRIVE 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.DiscussionThe 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 registrationInternational Standard Randomised Controlled Trials Number (ISRCTN) Registry, ISRCTN:21656568. Registered on 28 February 2014 (registered retrospectively (by 3 months)).

【 授权许可】

CC BY