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.
Adolescent
Adult
Child Abuse
/ prevention & control
Child Development
Child, Preschool
Education, Nonprofessional
/ methods
Female
Humans
Infant
Infant Behavior
Infant, Newborn
Maternal Health
Maternal Health Services
Mental Health
Mothers
/ education
Parent-Child Relations
Parenting
/ psychology
Pregnancy
Randomized Controlled Trials as Topic
Risk Factors
Scotland
Social Work
Time Factors
Vulnerable Populations
/ psychology
Young Adult
Hard to reach populations
Maternal mental health
Mothers
Parenting interventions
Perinatal mental health
Pregnancy
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
14 Aug 2019
14 Aug 2019
Historique:
received:
14
01
2019
accepted:
11
07
2019
entrez:
16
8
2019
pubmed:
16
8
2019
medline:
6
2
2020
Statut:
epublish
Résumé
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. 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. 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. International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ISRCTN:21656568 . Registered on 28 February 2014 (registered retrospectively (by 3 months)).
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ISRCTN:21656568 . Registered on 28 February 2014 (registered retrospectively (by 3 months)).
Identifiants
pubmed: 31412902
doi: 10.1186/s13063-019-3571-5
pii: 10.1186/s13063-019-3571-5
pmc: PMC6694522
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
499Subventions
Organisme : Chief Scientist office (Scotland, GB) and Scottish Government
ID : CSO (Scotland, GB) and Scottish Government (GN12KH589 THRIVE)
Organisme : Public Health Research Programme
ID : 11/3002/01
Organisme : Department of Health
ID : 11/3002/01
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_UU_12017/11
Pays : United Kingdom
Organisme : Chief Scientist Office
ID : SPHSU11
Pays : United Kingdom
Organisme : Chief Scientist Office
ID : SPHSU12
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_UU_12017/12
Pays : United Kingdom
Investigateurs
Catherine Nixon
(C)
Shona Shinwell
(S)
Jane White
(J)
Karen Crawford
(K)
Rosaleen O'Brien
(R)
Caoimhe Clarke
(C)
Kathleen Boyd
(K)
Alice MacLachlan
(A)
Commentaires et corrections
Type : ErratumIn
Références
Health Policy. 1990 Dec;16(3):199-208
pubmed: 10109801
Stat Med. 1999 Mar 30;18(6):681-94
pubmed: 10204197
J Consult Clin Psychol. 2000 Aug;68(4):624-40
pubmed: 10965638
Neuroimage. 2001 Dec;14(6):1290-301
pubmed: 11707085
Br J Clin Psychol. 2001 Nov;40(Pt 4):429-34
pubmed: 11760618
Child Care Health Dev. 2003 May;29(3):181-91
pubmed: 12752609
Psychoneuroendocrinology. 2005 Aug;30(7):647-56
pubmed: 15854781
Child Dev. 2005 Jul-Aug;76(4):763-82
pubmed: 16026495
Arch Womens Ment Health. 2006 Sep;9(5):233-42
pubmed: 16673041
Arch Dis Child. 2007 Mar;92(3):229-33
pubmed: 17068074
Arch Pediatr Adolesc Med. 2007 Aug;161(8):730-9
pubmed: 17679653
Res Nurs Health. 2008 Oct;31(5):442-53
pubmed: 18297638
Arch Womens Ment Health. 2008;11(1):57-65
pubmed: 18317709
Clin Child Fam Psychol Rev. 2008 Sep;11(3):114-44
pubmed: 18509758
J Womens Health (Larchmt). 2009 Feb;18(2):245-52
pubmed: 19183096
Econ Hum Biol. 2009 Mar;7(1):1-6
pubmed: 19213617
J Public Health (Oxf). 2009 Sep;31(3):423-33
pubmed: 19497944
Psychol Med. 2010 Apr;40(4):621-31
pubmed: 19671214
BMJ. 2011 Apr 07;342:d1548
pubmed: 21474510
Stress. 2011 Nov;14(6):614-26
pubmed: 21675865
Health Econ. 2012 Feb;21(2):187-200
pubmed: 22223561
Transl Psychiatry. 2011 Jul 19;1:e21
pubmed: 22832523
Infant Behav Dev. 2012 Dec;35(4):876-83
pubmed: 23007097
BMC Med. 2012 Nov 02;10:130
pubmed: 23121760
Acta Psychiatr Scand. 1990 Jul;82(1):77-81
pubmed: 2399824
Dev Med Child Neurol. 2015 Dec;57(12):1119-28
pubmed: 26257192
Trials. 2019 Jun 13;20(1):351
pubmed: 31196169
Br J Psychiatry. 1978 Feb;132:164-71
pubmed: 623950
Psychol Med. 1983 Aug;13(3):595-605
pubmed: 6622612
J Psychosom Res. 1984;28(1):43-51
pubmed: 6716327
Addiction. 1995 May;90(5):607-14
pubmed: 7795497
Am J Psychiatry. 1994 Aug;151(8):1132-6
pubmed: 8037246
J Psychosom Res. 1997 Oct;43(4):351-8
pubmed: 9330234
JAMA. 1998 Oct 14;280(14):1238-44
pubmed: 9786373
Child Abuse Negl. 1998 Nov;22(11):1065-78
pubmed: 9827312
Child Abuse Negl. 1998 Nov;22(11):1093-104
pubmed: 9827314