Evidence map›Paper›PMID 31412902›Full record

ArticleTrials2019

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.

Marion Henderson, Anja Wittkowski, Emma McIntosh, Alex McConnachie, Katie Buston, Philip Wilson, Rachel Calam, Helen Minnis, Lucy Thompson, John O'Dowd and 4 more

Erratum issuedAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Marion HendersonMedical Research Council/Chief Scientist Office Social and Public Health Sciences Unit, University of Glasgow, Top Floor 200 Renfield Street, Glasgow, G2 3AX, Scotland. Marion.Henderson@glasgow.ac.uk.ORCID http://orcid.org/0000-0001-7582-9516
Anja WittkowskiDivision of Psychology and Mental Health, School of Health Sciences, The University of Manchester, 2nd Floor Zochonis Building, Brunswick Street, Manchester, M13 9PL, England.
Emma McIntoshHealth Economics and Health Technology Assessment, University of Glasgow, Glasgow, G12 8QQ, Scotland.
Alex McConnachieRobertson Centre for Biostatistics, Boyd Orr Building, University of Glasgow, Glasgow, G12 8QQ, Scotland.
Katie BustonMedical Research Council/Chief Scientist Office Social and Public Health Sciences Unit, University of Glasgow, Top Floor 200 Renfield Street, Glasgow, G2 3AX, Scotland.
Philip WilsonCentre for Rural Health, University of Aberdeen, The Centre for Health Science, Old Perth Road, Inverness, IV2 3JH, Scotland.
Rachel CalamDivision of Psychology and Mental Health, School of Health Sciences, The University of Manchester, 2nd Floor Zochonis Building, Brunswick Street, Manchester, M13 9PL, England.
Helen MinnisInstitute of Health and Wellbeing, University of Glasgow, Caledonia House, Royal Hospital for Sick Children, Yorkhill, Glasgow, G3 8SJ, Scotland.
Lucy ThompsonCentre for Rural Health, University of Aberdeen, The Centre for Health Science, Old Perth Road, Inverness, IV2 3JH, Scotland.
John O'DowdNHS Ayrshire and Arran, Afton House, Ailsa Hospital Campus, Dalmellington Road, Ayr, KA6 6AB, Scotland.
James LawInstitute of Health and Society, School of Education, Communication and Language Sciences, University of Newcastle, Newcastle-upon-Tyne, NE1 7RU, England.
Elizabeth McGeeParenting and Family Support Research Programme, Department of Psychology and Allied Health Sciences, School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow, G4 0BA, Scotland.
Daniel WightMedical Research Council/Chief Scientist Office Social and Public Health Sciences Unit, University of Glasgow, Top Floor 200 Renfield Street, Glasgow, G2 3AX, Scotland.
THRIVE Trial Research Team

Funding

Chief Scientist Office SPHSU11Chief Scientist Office SPHSU12Chief Scientist office (Scotland, GB) and Scottish Government CSO (Scotland, GB) and Scottish Government (GN12KH589 THRIVE)Department of Health 11/3002/01Medical Research Council MC_UU_12017/11Medical Research Council MC_UU_12017/12Public Health Research Programme 11/3002/01
6 · The paper itself

Abstract

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

Indexed as

Maternal HealthMaternal Health ServicesMental HealthParent-Child RelationsAdolescentAdultChild AbuseChild DevelopmentChild, PreschoolEducation, NonprofessionalFemaleHumansInfantInfant BehaviorInfant, NewbornMothersHard to reach populationsMaternal mental healthMothersParenting interventionsPerinatal mental healthPregnancy

Identifiers

PMID31412902
PMCPMC6694522

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.