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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. Trial registration ISRCTN78814904. Registered on 17 May 2013. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2259-y) contains supplementary material, which is available to authorized users.

BackgroundFamily Nurse Partnership (FNP) is a home-based nurse home-visiting programme to support vulnerable parents. Group Family Nurse Partnership (gFNP) has similar aims and materials and was demonstrated to be feasible in implementation evaluations.ObjectivesTo determine whether or not gFNP, compared with usual care, could reduce risk factors for maltreatment in a vulnerable group and be cost-effective.DesignA multisite randomised controlled parallel-group trial and prospective economic evaluation, with eligible women allocated (minimised by site and maternal age group) to gFNP or usual care.SettingCommunity locations in the UK.ParticipantsExpectant mothers aged InterventionForty-four sessions of gFNP (14 during pregnancy and 30 in the first 12 months after birth) were offered to groups of between 8 and 12 women with similar expected delivery dates (the difference between the earliest and latest expected delivery date ranged from 8 to 10 weeks depending on the group) by two family nurses (FNs), one of whom had notified her intention to practise as a midwife.Main outcome measuresParenting was assessed by a self-report measure of parenting opinions, the Adult Adolescent Parenting Inventory Version 2 (AAPI-2), and an objective measure of maternal sensitivity, the CARE-Index. Cost-effectiveness was primarily expressed in terms of incremental cost per quality-adjusted life-year (QALY) gained.Data sourcesInterviews with participants at baseline and when infants were aged 2, 6 and 12 months. Cost information from nurse weekly logs and other service delivery data.ResultsIn total, 166 women were enrolled (99 to the intervention group and 67 to the control group). Adjusting for site and maternal age group, the intention-to-treat analysis found no effect of gFNP on either of the primary outcomes. AAPI-2 total was 7.5/10 [standard error (SE) 0.1] in both arms [difference also adjusted for baseline 0.08, 95% confidence interval (CI) –0.15 to 0.28;p = 0.50]. CARE-Index maternal sensitivity mean: intervention 4.0 (SE 0.3); control 4.7 (SE 0.4) (difference –0.76, 95% CI –1.67 to 0.13;p = 0.21). The sensitivity analyses supported the primary analyses. The probability that the gFNP intervention was cost-effective based on the QALY measure did not exceed 3%. However, in terms ofchangein AAPI-2 score (baseline to 12 months), the probability that gFNP was cost-effective reached 25.1%. A separate discrete choice experiment highlighted the value placed by both pregnant women and members of the general population on non-health outcomes that were not included in the QALY metric.LimitationsSlow recruitment resulted in smaller than ideal group sizes. In some cases, few or no sessions took place owing to low initial group size, and small groups may have contributed to attrition from the intervention. Exposure to gFNP sessions was below maximum for most group members, with only 58 of the 97 intervention participants receiving any sessions; FNs were experienced with FNP but were mainly new to delivering gFNP.ConclusionsThe trial does not support the delivery of gFNP as a means of reducing the risk of child abuse or neglect in this population.Future workA randomised controlled trial with modified eligibility to enable first-time mothers aged Trial registrationCurrent Controlled Trials ISRCTN78814904.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 5, No. 9. See the NIHR Journals Library website for further project information.