The NSPCC UK Minding the Baby® (MTB) home-visiting programme, supporting young mothers (aged 14–25) in the first 2 years of their baby's life: study protocol for a randomised controlled trial

Longhi et al. Trials The NSPCC UK Minding the Baby® (MTB) home-visiting programme, supporting young mothers (aged 14-25) in the first 2 years of their baby's life: study protocol for a randomised controlled trial Elena Longhi 0 Lynne Murray 2 3 Rachael Hunter 1 David Wellsted 6 Samantha Taylor-Colls 5 Kathryn MacKenzie 0 Gwynne Rayns 4 Richard Cotmore 4 Peter Fonagy 0 Richard M. Pasco Fearon 0 0 Research Department of Clinical , Educational and Health Psychology , University College London , Gower Street, London WC1E 6BT , UK 1 Priment Clinical Trials Unit, Research Department of Primary Care and Population Health, UCL, Royal Free Campus , London NW3 2PF , UK 2 School of Psychology and Clinical Language Sciences, University of Reading , Harry Pitt Building, Early Gate, Reading RG6 7BE , UK 3 Department of Psychology, Stellenbosch University , Private Bag X1, Matieland, Stellenbosch 7602 , South Africa 4 National Society for the Prevention of Cruelty to Children (NSPCC) , Weston House, 42 Curtain Road, London EC2A 3NH , UK 5 The Anna Freud Centre , 21 Maresfield Gardens, London NW3 5SD , UK 6 University of Hertfordshire , Hatfield AL10 9AB , UK Background: Young mothers living in low-income urban settings often are exposed to significant and chronic environmental difficulties including poverty, social isolation and poor education and typically also have to cope with personal histories of abuse and depression. Minding the Baby® (MTB) is an interdisciplinary home-visiting programme developed to support first-time young mothers, which integrates primary care and mental health approaches into a single intensive intervention from the last trimester of pregnancy until the child's second birthday. The primary aim of the intervention is to promote caregiver sensitivity, and, secondarily, to promote both child and maternal socioemotional outcomes. Methods/design: This is a multisite randomised controlled trial (RCT) with a target recruitment of 200 first-time adolescent mothers (under 26 years of age). One hundred participants will be randomised to the MTB group and they will receive the MTB programme in addition to the usual services available in their areas. Those participants not allocated to MTB will receive Treatment as Usual (TAU) only. Researchers will carry out blind assessments at baseline (before the birth of the baby), and outcome assessments around the child's first and second birthdays. The primary outcome will be the quality of maternal sensitivity and the secondary outcomes will focus on attachment security, child cognitive/language development, behavioural problems, postponed childbearing, maternal mental health and incidents of child protection interventions. Discussion: This study evaluates the Minding the Baby® programme in the UK. In particular, this RCT explores the effectiveness of this integrative approach, which focusses on maternal mental issues as well as parent-infant interaction, parental concerns and developmental outcomes. Trial registration: ISRCTN08678682 (date of registration 3 April 2014). Minding the Baby®; Home-visiting programme; First-time mothers; Attachment; Reflective functioning - Background Overview and rationale The NSPCC, in collaboration with University College London, the University of Reading, the Yale Child Study Centre and the Yale School of Nursing, is initiating a multisite study of the effectiveness of a targeted prevention programme that incorporates well-established principles of home visiting with a more comprehensive package of care for the developing mother-infant relationship. The programme represents an important opportunity to advance the UK’s provision of evidence-based support for at-risk families and to intervene effectively in the intergenerational cycle of disadvantage. The Minding the Baby® (MTB) programme is an interdisciplinary intervention that was developed and tested by a team of researchers and clinicians at the Yale Child Study Centre and the Yale School of Nursing [1]. MTB combines many of the benefits of home-visiting programmes – particularly their relative cost-effectiveness, client acceptability and accessibility – with a coherent, evidence-based clinical dimension that is informed by, and directly targets, wellstudied mechanisms of risk in early child development. In focussing on key domains of parent-child relationships where disturbances are known risk factors for later child maladjustment, particularly the sensitivity of parental care, the security of infant-parent attachment and the parent’s capacity to reflect on the child as an autonomous agent with needs, feelings and thoughts, the programme aims to combine best clinical practice in early prevention with scientific evidence regarding the developmental processes that promote optimal child outcomes. Currently, the UK health and social care systems offer a range of services to young families targeting mental health or promoting family relationships from birth, which are not alwa (...truncated)