ArticlePilot and feasibility studies2018
Right from the start: protocol for a pilot study for a randomised trial of the New Baby Programme for improving outcomes for children born to socially vulnerable mothers.
Article in Pilot and feasibility studies, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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.
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.
Who cites it
2 citing papers in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
backgroundChildren born to mothers who experience social complexity (e.g. substance misuse, intimate partner violence, mental ill health, a history of maltreatment) are at increased risk for a range of adverse outcomes at birth and during development. Home visiting programmes have been advocated as a strategy for improving outcomes for disadvantaged mothers and children, such as the Nurse-Family Partnership for young, socially disadvantaged first-time mothers. However, no evidence-based programme is available for multiparous women or older first-time mothers. The New Baby Programme was developed in Northern Ireland. It augments the universal health visiting service available in the UK with a content designed to promote maternal health and well-being in pregnancy, maximise secure attachments of children and parents and enhance sensitive parenting and infant cognitive development. METHODS/
designThis pilot study is designed to investigate whether it is possible to recruit and retain socially vulnerable mothers in a randomised trial that compares the effects of the New Baby Programme with standard antenatal and postnatal care. Feasibility issues include the referral/recruitment pathway (including inclusion and exclusion criteria), the consent and randomisation, the ability to maintain researcher blinding, the acceptability of the intervention to participants, and the feasibility and acceptability of the outcome measures. The results of the study will inform a definitive phase-3 RCT. DISCUSSION: Trials of complex social interventions often encounter challenges that lead to the trial being abandoned (e.g. because of problems in recruitment) or present considerable analytic challenges relating to dropout, attrition and bias. This pilot study aims to maximise the chances of successful implementation.
trial registrationISRCTN35456296 retrospectively registered.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.