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
Autor: | Henderson, Marion, Wittkowski, Anja, McIntosh, Emma, McConnachie, Alex, Buston, Katie, Wilson, Philip, Calam, Rachel, Minnis, Helen, Thompson, Lucy, O'Dowd, John, Law, James, McGee, Elizabeth, Wight, Daniel, Nixon, Catherine, Shinwell, Shona, White, Jane, Crawford, Karen, O'Brien, Rosaleen, Clarke, Caoimhe, Boyd, Kathleen, MacLachlan, Alice |
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Jazyk: | angličtina |
Rok vydání: | 2019 |
Předmět: |
medicine.medical_specialty
Clinical Trial Protocol Referral Population Psychological intervention Medicine (miscellaneous) Poison control Mothers Parenting interventions Suicide prevention Occupational safety and health law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Pregnancy Hard to reach populations Journal Article Medicine Pharmacology (medical) 030212 general & internal medicine education lcsh:R5-920 education.field_of_study Maternal mental health business.industry Mental health Family medicine Perinatal mental health lcsh:Medicine (General) business 030217 neurology & neurosurgery |
Zdroj: | Trials, Vol 20, Iss 1, Pp 1-15 (2019) 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 & Trial Research Team, THRIVE 2019, ' Trial of healthy relationships initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps in mothers 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, vol. 20, 499 . https://doi.org/10.1186/s13063-019-3571-5 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 & MacLachlan, A 2019, ' Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps 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, vol. 20, no. 1, 499 . https://doi.org/10.1186/s13063-019-3571-5 |
ISSN: | 2165-6568 1745-6215 |
Popis: | 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)). |
Databáze: | OpenAIRE |
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