Journal article
Randomized controlled trial and economic evaluation of nurse-led group support for young mothers during pregnancy and the first year postpartum versus usual care.
- Abstract:
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Background
Child maltreatment is a significant public health problem. Group Family Nurse Partnership (gFNP) is a new intervention for young, expectant mothers implemented successfully in pilot studies. This study was designed to determine the effectiveness and cost-effectiveness of gFNP in reducing risk factors for maltreatment with a potentially vulnerable population.
Methods
A multi-site, randomized controlled, parallel-arm trial and prospective economic evaluation was conducted, with allocation via remote randomization (minimization by site, maternal age group) to gFNP or usual care. Participants were expectant mothers aged below 20 years with at least one live birth, or aged 20–24 years with no live births and with low educational qualifications. Data from maternal interviews at baseline and when infants were 2, 6 and 12 months, and video-recording at 12 months, were collected by researchers blind to allocation. Cost information came from weekly logs completed by gFNP family nurses and other service delivery data reported by participants. Primary outcomes measured at 12 months were parenting attitudes (Adult-Adolescent Parenting Index, AAPI-2) and maternal sensitivity (CARE Index). The economic evaluation was conducted from a UK NHS and personal social services perspective with cost-effectiveness expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The main analyses were intention-to-treat with additional complier average causal effects (CACE) analyses.
Results
Between August 2013 and September 2014, 492 names of potential participants were received of whom 319 were eligible and 166 agreed to take part, 99 randomly assigned to receive gFNP and 67 to usual care. There were no between-arm differences in AAPI-2 total (7·5/10 in both, SE 0.1), difference adjusted for baseline, site and maternal age group 0·06 (95% CI − 0·15 to 0·28, p = 0·59) or CARE Index (intervention 4·0 (SE 0·3); control 4·7 (SE 0·4); difference adjusted for site and maternal age group − 0·68 (95% CI − 1·62 to 0·16, p = 0·25) scores. The probability that gFNP is cost-effective based on the QALY measure did not exceed 3%.
Conclusions
The trial did not support gFNP as a means of reducing the risk of child maltreatment in this population but slow recruitment adversely affected group size and consequently delivery of the intervention./p>
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, pdf, 1.1MB, Terms of use)
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- Publisher copy:
- 10.1186/s13063-017-2259-y
Authors
- Publisher:
- BioMed Central
- Journal:
- Trials More from this journal
- Volume:
- 18
- Issue:
- 1
- Pages:
- 508
- Publication date:
- 2017-11-01
- Acceptance date:
- 2017-10-13
- DOI:
- EISSN:
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1745-6215
- ISSN:
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1745-6215
- Pmid:
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29092713
- Language:
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English
- Keywords:
- Pubs id:
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pubs:743712
- UUID:
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uuid:56d8f848-ffe5-4c61-b3da-4035f5e43662
- Local pid:
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pubs:743712
- Source identifiers:
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743712
- Deposit date:
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2017-12-02
Terms of use
- Copyright holder:
- Barlow et al
- Copyright date:
- 2017
- Notes:
- © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
- Licence:
- CC Attribution (CC BY)
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