The effectiveness and cost-effectiveness of the Family Nurse Partnership home visiting programme for first time teenage mothers in England: a protocol for the Building Blocks randomised controlled trial

BMC Pediatrics

Michael Robling⁵  David Torgerson²  Eugena Stamuli²  Julia Sanders⁵  Sarah Ronaldson⁷  Zoë Roberts¹  Gerry Richardson³  Kate E Pickett²  Gwenllian Moody⁵  Alan Montgomery⁴  Belen Corbacho Martin²  Joyce Kenkre⁷  Alison Kemp¹  John W Gregory⁶  Kerenza Hood⁵  Sue Channon¹  Rebecca Cannings-John⁵  Chris C Butler¹  Marie-Jet Bekkers⁵  Eleri Owen-Jones⁵ 

[1]Cochrane Institute of Primary Care and Public Health, School of Medicine, Cardiff University, Heath Park, Cardiff, Wales CF14 4YS, UK

[2]Department of Health Sciences, University of York, Seebohm Rowntree Building, Heslington, York YO10 5DD, UK

[3]Centre for Health Economics, University of York, Heslington, York YO10 5DD, UK

[4]Nottingham Clinical Trials Unit, Nottingham Health Science Partners, C Floor, South Block, Queen’s Medical Centre, Nottingham NG7 2UH, UK

[5]South East Wales Trials Unit (SEWTU), School of Medicine, Cardiff University, Neuadd Meirionnydd 7th Floor, Heath Park, Cardiff, Wales CF14 4YS, UK

[6]Institute of Molecular and Experimental Medicine, Cardiff University, Heath Park, Cardiff, Wales CF14 4XW, UK

[7]University of South Wales, Pontypridd, Wales CF37 1DL, UK

关键词: Randomised controlled trial;    Early years prevention;    Family nurse partnership;    Child maltreatment;    Smoking cessation;    Birth weight;    Home visiting;    Maternal health;    Prenatal care;    Pregnancy in adolescence;   

Others  :  1144675
DOI  :  10.1186/1471-2431-13-114

 received in 2013-07-12, accepted in 2013-07-22,  发布年份 2013

【 摘 要 】

Background

The Nurse Family Partnership programme was developed in the USA where it is made available to pregnant young mothers in some socially deprived geographic areas. The related Family Nurse Partnership programme was introduced in England by the Department of Health in 2006 with the aim of improving outcomes for the health, wellbeing and social circumstances of young first-time mothers and their children.

Methods / design

This multi-centre individually randomised controlled trial will recruit 1600 participants from 18 Primary Care Trusts in England, United Kingdom. The trial will evaluate the effectiveness of Family Nurse Partnership programme and usual care versus usual care for nulliparous pregnant women aged 19 or under, recruited by 24 weeks gestation and followed until the child’s second birthday. Data will be collected from participants at baseline, 34-36 weeks gestation, 6, 12, 18 and 24 months following birth. Routine clinical data will be collected from maternity, primary care and hospital episodes statistics. Four primary outcomes are to be reported from the trial: birth weight; prenatal tobacco use; child emergency attendances and/or admissions within two years of birth; second pregnancy within two years of first birth.

Discussion

This trial will evaluate the effectiveness and cost effectiveness of the Family Nurse Partnership in England. The findings will provide evidence on pregnancy and early childhood programme outcomes for policy makers, health professionals and potential recipients in three domains (pregnancy and birth, child health and development, and parental life course and self-sufficiency) up to the child’s second birthday.

Trial registration

Trial registration number: ISRCTN 23019866

【 授权许可】

   
2013 Owen-Jones et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Kuh D, Hardy R, Langenberg C, Richards M, Wadsworth MEJ: Mortality in adults aged 26-54 years related to socioeconomic conditions in childhood and adulthood: post war birth cohort study. Br Med J 2002, 325(7372):1076-1080.
• [2]Power C, Matthews S: Origins of health inequalities in a national population sample. Lancet 1997, 350(9091):1584-1589.
• [3]Lissau I, Sorensen TIA: Parental neglect during childhood and increased risk of obesity in young adulthood. Lancet 1994, 343(8893):324-327.
• [4]Galobardes B, Lynch JW, Smith GD: Childhood socioeconomic circumstances and cause-specific mortality in adulthood: systematic review and interpretation. Epidemiol Rev 2004, 26:7-21.
• [5]Evans GW, English K: The environment of poverty: multiple stressor exposure, psychophysiological stress, and socioemotional adjustment. Child Dev 2002, 73(4):1238-1248.
• [6]Office for National Statistics: Review of the National Statistician on births and patterns of family building in England and Wales, Correction Notices Birth Statistics 2008. Newport: ONS; 2010. FM1(37): 1-79
• [7]Botting B, Rosato M, Wood R: Teenage mothers and the health of their children. Popul Trends 1998, 93:19-28.
• [8]Moffitt TE: Teen-aged mothers in contemporary Britain. J Child Psychol Psychiatry 2002, 43(6):727-742.
• [9]Ward C, Lewis S, Coleman T: Prevalence of maternal smoking and environmental tobacci smoke exposure during pregnancy and impact on birth weight: retrospective study using Millenium Cohort. BMC Publ Health 2007, 7(81): . BioMed Central Full Text
• [10]NHS Information Centre: Statistics on smoking: England, 2006. Leeds: NHS 13/HSCIC; 2006:1-146.
• [11]Graham H, Inskip HM, Francis B, Harman J: Pathways of disadvantage and smoking careers: evidence and policy implications. J Epidemiol Community Health 2006, 60(2):ii7-ii12.
• [12]The US Department of Health and Human Services: 2004 Surgeon General’s Report - The Health Consequences of Smoking. Atlanta: Centers for Disease Control and Prevention; 2004:1-903.
• [13]Nabet C, Ancel P-Y, Burguet A, Kaminski M: Smoking during pregnancy and preterm birth according to obsteric history: French national perinatal surveys. Paediatr Perinat Epidemiol 2005, 19(2):88-96.
• [14]Wakschlag WS, Lahey BB, Loeber R, Green SM, Gordon RA, Leventhal BL: Maternal smoking during pregnancy and the risk of conduct disorder in boys. Arch Gen Psychiatry 1997, 54(7):670-676.
• [15]Wakschlag LS, Pickett KE, Cook E, Benowitz NL, Leventhal BL: Maternal smoking during pregnancy and severe antisocial behavior in offspring: a review. Am J Public Health 2002, 92(6):966-974.
• [16]Button TMM, Maughan B, McGuffin P: The relationship of maternal smoking to psychological problems in the offspring. Early Hum Dev 2007, 83(11):727-732.
• [17]Julvez J, Ribas-Fito N, Torrent M, Forns M, Garcia-Esteban R, Sunyer J: Maternal smoking habits and cognitive development of children at age 4 years in a population-based birth cohort. Int J Epidemiol 2007, 36(4):825-832.
• [18]Horta BL, Victoria CG, Menezes AM, Barros FC: Environmental tobacco smoke and breastfeeding duration. Am J Epidemiol 1997, 146(2):128-133.
• [19]United Nations Children’s Fund and World Health Organisation: Low birthweight: country, regional and global estimates. New York: UNICEF; 2004:1-31.
• [20]World Health Organization: Reproductive health indicators database. Geneva: World Health Organization; 2006.
• [21]Roberts EM: Neighborhood Social Environments and the Distribution of Low Birthwieght in Chicago. Am J Public Health 1997, 87(4):597-603.
• [22]Wiles NJ, Peters TJ, Leon DA, Lewis G: Birth weight and psychological distress at age 45-51 years Results from the Aberdeen Children of the 1950s cohort study. Br J Psychiatry 2005, 187:21-28.
• [23]Barker DJP: Fetal origins of cardiovascular disease. Ann Med 1999, 31(1):3-6.
• [24]NICE: Antenatal Care: NICE clinical guideline 62. Manchester: National Institute for Health and Clinical Excellence; 2008.
• [25]NICE: Routine postnatal care of women and their babies: NICE clinical guideline 37. Manchester: National Institute for Health and Clinical Excellence; 2006.
• [26]National Collaborating Centre for Women’s and Children’s Health: Pregnancy and complex social factors:A model for service provision for pregnant women with complex social factors. London: Royal College of Obstetricians and Gynaecologists; 2010:1-321.
• [27]Melhuish E, Belsky J, Barnes J: Evaluation and the value of Sure Start. Arch Dis Child 2010, 95:159-161.
• [28]Wiggins M, Rosato M, Austerberry H, Sawtell M, Oliver S: Sure Start Plus National Evaluation: Final Report. London: Social Science Research Unit, Institute of Education, University of London; 2005:1-110.
• [29]Olds DL: Prenatal and infancy home visiting by nurses: from randomized trials to community replication. Prev Sci 2002, 3(3):153-172.
• [30]Nurse-Family Partnership: National Snapshot – Nurse Family Partnership. Denver, CO: NFP National Service Office; 2013:1.
• [31]Bronfenbrenner U: The ecology of human development: experiments by nature and design. Boston, MA: Harvard University Press; 1979.
• [32]Bandura A: Self-efficacy: toward a unifying theory of behavioural change. Psychol Rev 1977, 84(2):191-215.
• [33]Bowlby J: Attachment and Loss, vol. 1: Attachment. New York: Basic Books; 1982.
• [34]Rollnick S, Miller WR, Butler CC: Motivational Interviewing In Healthcare. New York: Guildford Press; 2008.
• [35]Miller WR, Rollnick S: Motivational Interviewing: Preparing People for Change. 2nd edition. New York: Guildford Press; 2002.
• [36]Olds D, Henderson CRJ, Cole R, Eckenrode J, Kitzman H, Luckey D, Pettitt L, Sidora K, Morris P, Powers J: Long-term effects of nurse home visitation on behavior - 15-year follow-up of a randomized controlled trial. JAMA 1998, 280(14):1238-1244.
• [37]Olds D, Henderson CRJ, Kitzman H, Cole R: Effects of Prenatal and Infancy Nurse Home Visitation on Surveillance of Child Maltreatment. Pediatrics 1995, 95(3):365-372.
• [38]Olds DL, Henderson CRJ, Chamberlin R, Tatelbaum R: Preventing child abuse and neglect: a randomized trial of nurse home visitation. Pediatrics 1986, 78(1):65-78.
• [39]Olds DL, Henderson CRJ, Kitzman H: Does prenatal and infancy home visitation have enduring effects on qualities of parental caregiving and child health at 25 to 50 months of life? Pediatrics 1994, 93(1):89-98.
• [40]Olds DL, Henderson CRJ, Tatelbaum R, Chamberlin R: Improving the delivery of prenatal care and outcomes of pregnancy: a randomized trial of nurse home visitation. Pediatrics 1986, 77(1):16-28.
• [41]Olds DL, Henderson CRJ, Tatelbaum R, Chamberlin R: Improving the life-course development of socially disadvantaged mothers: a randomized trial of nurse home visitation. Am J Public Health 1988, 78(11):1436-1445.
• [42]Olds DL, Kitzman H, Cole R, Robinson J, Sidora K, Luckey DW, Henderson CRJ, Hanks C, Bondy J, Holmberg J: Effects of nurse home-visiting on maternal life course and child development: age 6 follow-up results of a randomized trial. Pediatrics 2004, 114(6):1550-1559.
• [43]Olds DL, Kitzman H, Hanks C, Cole R, Anson E, Sidora-Arcoleo K, Luckey DW, Henderson CRJ, Holmberg J, Tutt RA, et al.: Effects of nurse home visiting on maternal and child functioning: age 9 follow-up of a randomized trial. Pediatrics 2006, 120(4):832-845.
• [44]Olds DL, Robinson J, O’Brien R, Luckey D, Pettitt LM, Henderson CRJ, Ng RK, Sheff KL, Korfmacher J, Hiatt S, et al.: Home visiting by paraprofessionals and by nurses: a randomized, controlled trial. Pediatrics 2002, 110(3):486-496.
• [45]Olds DL, Robinson J, Pettitt L, Luckey DW, Holmberg J, Ng RK, Isacks K, Sheff K, Henderson CRJ: Effects of home visits by paraprofessionals and by nurses: age 4 follow-up results of a randomized trial. Pediatrics 2004, 114(6):1560-1568.
• [46]Karoly LA, Greenwood PW, Everingham SS, Hoube J, Kilburn RM, Rydell CP, Sanders M, Chiesa J: Investing in Our Children: What we know and don’t know about the costs and benefits of early childhood interventions. Santa Monica: The RAND Corporation; 1998.
• [47]Barnes J, Ball M, Meadows P, McLeish J, Belsky J, Team FIR: Nurse-Family Partnership Programme: First Year Pilot Sites Implementation in England - Pregnancy and the Post-partum Period. London: Birkbeck, University of London; 2008.
• [48]Barnes J, Ball M, Meadows P, Belsky J, Team FIR: Nurse-Family Partnership Programme: Second Year Pilot Sites Implementation in England - The Infancy Period. London: Birkbeck, University of London; 2009.
• [49]Ball M, Barnes J, Meadows P: Issues emerging from the first 10 pilot sites implementing the Nurse-Family Partnership home-visiting programme in England. London: Birkbeck, University of London; 2012.
• [50]Calderwood L, Ward K, other members of the Millennium Cohort Team: Millennium Cohort Study First Survey: Derived Variables. London: Centre for Longitudinal Studies, Bedford Group for Lifecourse & Statistical Studies, Institute of Education, University of London; 2004.
• [51]NatCen: Millennium Cohort Study First Survey: CAPI Questionnaire Documentation. London: Institute of Education, University of London; 2003.
• [52]EQ-5D Website. [http://www.euroqol.org/ webcite]
• [53]Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SLT, Walters EE, Zaslavsky AM: Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med 2002, 32(6):959-976.
• [54]Whooley MA, Avins AL, Miranda J, Browner WS: Case-finding instruments for depression - two questions are as good as many. J Gen Intern Med 1997, 12(7):439-445.
• [55]Cox JL, Holden JM, Sagovsky R: Detection of postnatal depression - development of the 10-item edinburgh postnatal depression scale. Br J Psychiatry 1987, 150:782-786.
• [56]The General Self-Efficacy Scale. [http://userpage.fu-berlin.de/~health/selfscal.htm webcite]
• [57]Booth CL, Mitchell SK, Barnard KE, Sieker SJ: Development of Maternal Social Skills in Multiproblem Families: Effects on the Mother-Child Relationship. Dev Psychol 1989, 25(3):403-412.
• [58]Barnard K, Hilsinger G, Patteson D, Snyder C, Solchany J, Shangle M: Washington State Public Health Training Plan: Improving Child-Family Health. Parent Protective Factors Project (1995-1999) Final Report July, 1999. Washington: US Department of Health; 1999.
• [59]Hegarty K: Composite Abuse Scale Manual. Melbourne: Department of General Practice, University of Melbourne; 2007.
• [60]Wakschlag LS, Pickett KE, Middlecamp MK, Walton LL, Tenzer P, Leventhal BL: Pregnant smokers who quit, pregnant smokers who don’t: does history of problem behavior make a difference? Soc Sci Med 2003, 56(12):2449-2460.
• [61]Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO: The fagerstrom test for nicotine dependence - a revision of the fagerstrom tolerance questionnaire. Br J Addict 1991, 86(9):1119-1127.
• [62]Knight JR, Sherritt L, Shrier LA, Harris SK, Chang G: Validity of the CRAFFT substance abuse screening test among adolescent clinic patients. Arch Pediatr Adolesc Med 2002, 156(6):607-614.
• [63]Hays RD, Sherbourne CD, Mazel RM: User’s Manual for the Medical Outcomes Study (MOS) Core Measures of Health-Related Quality of Life. Santa Monica, CA: Rand; 1995.
• [64]Sherbourne CD, Stewart AL: The MOS social support survey. Soc Sci Med 1991, 32(6):705-714.
• [65]Dunst CJ, Leet HE: Measuring the adequacy of resources in households with young children. Child Care Health Dev 1987, 13(2):111-125.
• [66]Rust J, Bennun I, Crowe M, Golombok S: The GRIMS. A psychometric instrument for the assessment of marital discord. J Fam Ther 1990, 12(1):45-57.
• [67]Muller ME: A questionnaire to measure mother-to-infant attachment. J Nurs Meas 1994, 2(2):129-141.
• [68]Crittenden PM: CARE-Index: Coding Manual. Unpublished manuscript. Miami, FL: available from the author; 1979 - 2004.
• [69]Bellman M, Lingam S, Aukett A: Schedule of Growing Skills II (SOGS II). 2nd edition. London: GL Assessment Limited; 1996.
• [70]Coplan J, Gleason JR, Ryan R, Burke MG, Williams ML: Validation of an early language milestone scale in a high-risk population. Pediatrics 1982, 70(5):677-683.
• [71]Holtby S, Zahnd E, Lordi N, McCain C, Chia YJ, Kurata J: Health of California’s Adults, Adolescents and Children: Findings from CHIS 2003 and CHIS 2001. Los Angeles, CA: UCLA Center for Health Policy Research; 2006.
• [72]Barnes J, Ball M, Meadows P, Howden B, Jackson A, Henderson J, Niven L: The Family-Nurse Partnership Programme in England: Wave 1 implementation in toddlerhood & a comparison between Waves 1 and 2a of implementation in pregnancy and infancy. In London: Institute for the Study of Children, Families and Social Issues. Birkbeck: University of London; 2011:127.
• [73]Dukic VM, Niessner M, Benowitz N, Hans S, Wakschlag L: Modeling the relationship of cotinine and self-reported measures of maternal smoking during pregnancy: a deterministic approach. Nicotine Tob Res 2007, 9(4):453-465.
• [74]Oakley A, Strange V, Bonell C, Allen E, Stephenson J: Process evaluation in randomised controlled trials of complex interventions. BMJ 2006, 322(7538):413-416.
• [75]Saunders RP, Evans MH, Joshi P: Developing a process evaluation plan for assessing health promotion program implementation: a how-to guide. Health Promot Pract 2005, 6(2):134-147.
• [76]Rollnick S, Miller WR: What is motivational interviewing? Behav Cogn Psychother 1995, 23:325-334.
• [77]Moyers TB, Martin T, Manuel JK, Miller WR, Ernst D: Revised Global Scales: Motivational Interviewing Treatment Integrity 3.1.1 (MITI 3.1.1). Albuquerque, NM: University of New Mexico, Center on Alcoholism, Substance Abuse and Addictions (CASAA); 2010.
• [78]Curtis L: Unit Costs of Health & Social Care 2011. Canterbury: Personal Social Services Research Unit; 2011.
• [79]2010-11 reference costs publication[https://www.gov.uk/government/publications/2010-11-reference-costs-publication webcite]