Title: Randomised trial of the effectiveness of Group Family Nurse Partnership (gFNP) programme in improving outcomes for high-risk mothers and preventing abuse
Funder: Department of Health (England)

Abstract: Study design:The study will comprise a randomised controlled trial in which eligible families will be randomly allocated to one of two arms i) gFNP delivered over 76 weeks; ii) standard care. Setting:Family Nurses employed by the local NHS trust in conjunction with local councils as part of the Family Nurse Partnership team will provide the intervention in local Sure Start Childrens Centres.Inclusion criteria:Expectant mothers prior to 16 weeks gestation and with expected delivery dates within 4 to 6 weeks of each other (per site). Eligibility criteria are either: aged under 20 expecting second or subsequent child no qualifications or maximum 4 GCSEs at Grade C; or aged 20 to 23 expecting first or subsequent child no educational qualifications or maximum 4 GCSEs at C and one of: current or history of mental health problems ever in care of social services lives in workless household or never employed.Intervention:Group Family Nurse Partnership (gFNP) - groups of on average 10 women with similar due dates and partners if applicable starting at 16 weeks gestation and extending until infants are one year; comprises 14 2-hour pregnancy sessions and 30 in infancy all based on materials originally used for the Nurse Family Partnership(NFP) programme. One of the two Family Nurses is also a qualified midwife who provides routine antenatal midwifery care; both FNs provide postnatal routine infant checks.Recruitment (see Figure 1)Parents will with the support of the midwifery team be recruited by researchers at or soon after their the booking-in visit. The midwife will identify all eligible women and with oral agreement provide their details to the researcher who will then explain the study in more detail including the randomization. They will be given 24 hours to make a decision after which time the researcher will telephone. If verbal consent is given a home visit will be made immediately or as soon as possible to obtain written consent and baseline details. Researchers will telephone the clinical trials unit so that randomization can occur. Consenting participants will be informed about the group to which they have been allocated by the researcher and those receiving the intervention will be contacted by the FNP team who will be given the details of intervention families by the Trial Manager. SampleThe standard deviation (SD) of the short form Child Abuse Potential Inventory in the target population is approximately 6.3 (Ondersma et al. 2005). We propose to recruit sufficient mothers and babies (families) to allow the trial to detect a difference between groups of 0.5 standard deviations with 90% power at a significance level of 0.05 (2-tailed); this is considered to represent a moderate size of effect . Very conservatively assuming a correlation of 0.4 between pre and post intervention scores we would need 71 families in each arm of the trial to detect this difference. Conservatively allowing for an expected 30% drop out rate (based on pilot sites) we would therefore need to recruit a minimum of 84 families per arm of the trial. We therefore propose to recruit 100 families per arm. In the intervention arm this will consist of 10 groups of (generally) 10 families provided in 5 FNP sites (N=100). Allocation to groups:Consenting parents will be randomly allocated to one of two arms Randomisation will be conducted by the LSHTM Clinical Trials Unit who will provide a 24 hour telephone contact system.Data collection:The data will comprise a range of self-report questionnaires and (at 12-13 months) recorded observations of the parent and infant and hospital attendance data from HES. Data will be collected at baseline (before randomisation) for demographic data and all questionnaire outcomes at 2-3 months (CAP EPDS; PSI); and immediately post-intervention when the infants are 12 months (all outcomes including the CARE index). Maternal quality of life information (EuroQuol EQ-5D SF-36) will be collected at 2 6 and 12 months. Data will be collected in the respondent’s home.Participating families will be given a £20 Boots Gift Vouchers at each data collection point as an acknowledgment of their contribution and to promote compliance.Methods for protecting against bias:The researcher will be blind to the intervention groups at baseline data collection but from that point will be aware of allocation which would in any event become evident from participants responses and conversation. Measurement of outcomes and duration of follow-up:Primary outcomes: The short form of the Child Abuse Potential Inventory (CAP Milner 1990) a self-report questionnaire measuring distress rigidity family problems unhappiness feelings of persecution financial problems and loneliness discriminates between abusive and non-abusive parents; and at 12 months maternal sensitivity and infant cooperativeness as identified with the CARE-Index (Crittenden1974-2004; 1981) an observational measure which identifies relationships and interactions indicative of maltreatment.Secondary outcomes: maternal depression - Edinburgh Postnatal Depression Scale (Cox et al. 1987); parental distress (Parenting Stress Index Abidin 1995); contact with social services indicative of child abuse concerns; hospital A&E attendance (injuries ingestion poisoning); and maternal health related quality of life (EuroQuol EQ-5D SF-36).Programme integrity:Compliance with the programme will be assessed during supervision to assess the extent to which a number of key criteria are being met by the practitioners. In addition information from anonymised standardised data forms completed by the nurses will be examined so that it can be determined whether the content of the sessions conforms with the programme objectives for covering the five programme domains: maternal role maternal health family and friends life course and environmental health. Attendance per group and individual dosage will also be determined from these formsProcess data:Data will be collected about participants who a) refuse to take part in the study; b) drop-out of the intervention/study including quantitative demographic data and qualitative data to explore reasons for non-participation or discontinuation. Qualitative data will be collected to indicate the acceptability of the programme for clients and practitioners and other local service providers and commissioners.Data analysis:All primary analyses will be carried out according to the principle of intention-to-treat. Every effort will be made to obtain outcome measures on participants even if some drop out during the course of the group sessions. The data will be analysed by multiple regression modelling fitting baseline measures of outcomes as covariates where available. The small groups in which the intervention is delivered will be fitted as a random effect. A small number of secondary analyses based on explicit hypotheses e.g. subgroup/ explanatory analyses (considering compliance with the interventions) will be specified in advance. Qualitative data will be transcribed and analysed thematically using NVivo 8.Economic evaluation:We will assess the costs of gFNP implementation in each area and assess the extent to which variations in implementation and uptake have an impact on costs. Simple modeling will be used to assess cost changes given differential uptake (service providers staff training see section). Incremental cost-effectiveness ratios per unit of improvement will be calculated. Given the plethora of outcome measures across several domains a separate discrete choice experiment (DCE) will be conducted amongst trial participants at the final point of follow-up. The outputs of the DCE will be combined with cost estimates and changes in relevant outcomes to generate cost-benefit ratios.Research Governance:The proposed research will be conducted in accordance with the Research Governance framework. Ethical committee approval will be obtained from NHS research ethics committee for a multi-centre study and from each local R&D.Project timetable including recruitment rate (see Figure 2):5/12 to 8/12 gain ethical approval; finalise details of participant interviews; 9/12 to 3/13 recruit and collect baseline data one site in first month and two sites per month for 4 months with the final group in the 6th month to allow for some slippage (total N=200); 3/13 to 6/13 process interviews on recruitment; 6/13 to 12/13 conduct 2-3 month research visits 35 per month; 10/13 to 4/14 6 month telephone contacts; 3/14 to 6/14 process interviews with professionals; 3/14 to 9/14 conduct 12/13 month observations and interviews. 9/14 to 11/14 acceptability interviews with clients; 10/14 to 11/14 code CARE observations. Data entry cleaning and preliminary analysis ongoing. 11/14 to 4/15 prepare final report.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: GENERIC HEALTH RELEVANCE;REPRODUCTIVE HEALTH AND CHILDBIRTH