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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

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

Authors: Elena Longhi, Lynne Murray, Rachael Hunter, David Wellsted, Samantha Taylor-Colls, Kathryn MacKenzie, Gwynne Rayns, Richard Cotmore, Peter Fonagy, Richard M. Pasco Fearon

Published in: Trials | Issue 1/2016

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Abstract

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).
Appendix
Available only for authorised users
Literature
1.
Sadler LS, Slade A, Close N, Webb DL, Simpson T, Fennnie K, Mayer LC. Minding the Baby: enhancing reflectiveness to improve early health and relationship outcomes in an interdisciplinary home visiting program. Infant Mental Health J. 2013;34(5):391–405.CrossRef
2.
Olds D, Henderson Jr CR, Kitzman HJ, Enckerode JJ, Cole RE, Tatelbaum RC. Prenatal and infancy home visitation by nurses: recent findings. Future Child. 1999;9(1):44–65.CrossRefPubMed
3.
Olds D, Kitzman H, Cole R, Robinson JA. Theoretical foundations of a program of home visitation for pregnant women and parents of young children. J Community Psychol. 1997;25(1):9–25.CrossRef
4.
5.
Goldberg S. Attachment and development. London: Arnold; 2000.
6.
Ordway M, Sadler LS, Dixon J, Close N, Mayes L, Slade A. Lasting effects of an interdisciplinary home visiting program on child behavior: preliminary follow-up results of a randomized trial. J Pediatr Nurs. 2014;29(1):3–13.CrossRefPubMed
7.
Ermisch J. Does a ‘teen-birth’ have longer-term impacts on the mother? Suggestive evidence from the British Household Panel Study. IDEAS Working Papers Series of the Institute for Social and Economic Research, paper 2003–32. Colchester: University of Essex RePEc; 2003.
8.
Swann C, Bowe K, McCormick G, Kosmin M. Teenage pregnancy and parenthood: a review of reviews Great Britain: NHS Health Development Agency; National Institute for Health and Clinical Excellence. 2003.
9.
Lesser J, Koniak-Griffin D. The impact of physical or sexual abuse on chronic depression in adolescent mothers. J Pediatr Nurs. 2000;15(6):378–87.CrossRefPubMed
10.
Pearlin L, Menaghan EG, Lieberman MA, Mullan JT. The stress process. J Health Soc Behav. 1981;22(4):337–56.CrossRefPubMed
11.
Sadler L, Anderson SA, Sabatelli RM. Parental competence among African American adolescent mothers and grandmothers. J Pediatr Nurs. 2001;16(4):217–33.CrossRefPubMed
12.
Sadler LS, Swartz MK, Ryan-Krause P. Supporting adolescent mothers and their children through a high school-based child care center and parent support program. J Pediatr Health Care. 2003;17(3):109–17.PubMed
13.
Singh G, Ghandour RM. Impact of neighborhood social conditions and household socioeconomic status on behavioral problems among US children. Matern Child Health J. 2012;16(1):158–69.CrossRef
14.
15.
Sellström E, Bremberg S. The significance of neighbourhood context to child and adolescent health and well-being: a systematic review of multilevel studies. Scand J Public Health. 2006;34(5):544–54.CrossRefPubMed
16.
Olds D, Robinson J, O’Brien R, Luckey DW, Pettitt LM, Henderson CR, et al. Home visiting by paraprofessionals and by nurses: a randomized, controlled trial. Pediatrics. 2002;110(3):486–96.CrossRefPubMed
17.
Kitzman H, Olds DL, Henderson Jr CR, Hanks C, Cole R, Tatelbaum R, et al. Effect of prenatal and infancy home visitation by nurses on pregnancy outcomes, childhood injuries, and repeated childbearing: a randomized controlled trial. JAMA. 1997;278:644–52.CrossRefPubMed
18.
Kitzman H, Olds DL, Sidora K, Henderson CR, Hanks C, Cole R, et al. Enduring effects of nurse home visitation on maternal life course: a 3 year follow up of a randomised trial. JAMA. 2000;283(15):1983–9.CrossRefPubMed
19.
Olds D, Henderson Jr CR, Phelps C, Kitzman H, Hanks C. Effects of prenatal and infancy nurse home visitation on government spending. Med Care. 1993;31(2):156–74.CrossRef
20.
Olds D, Henderson Jr CR, Cole R, Eckenrode J, Kitzman H, Luckey D, et al. Long-term effects of nurse home visitation on children’s criminal and antisocial behaviour: 15 year follow-up of a randomised controlled trial. JAMA. 1998;280(14):1238–44.CrossRefPubMed
21.
Olds D, Hill P, Robinson J, Song N, Little C. Update on home visiting for pregnant women and parents of young children. Curr Probl Pediatr. 2000;30(4):107–41.PubMed
22.
Olds D, Kitzman HJ. Review of research on home visiting for pregnant women and parents of young children. Future Child. 1993;3(3):53–92.CrossRef
23.
Olds D. Prenatal and infancy home visiting by nurses: from randomized trials to community replication. Prev Sci. 2002;3(3):153–72.CrossRefPubMed
24.
Lieberman A, Weston DR, Pawl JH. Preventive intervention and outcome with anxiously attached dyads. Child Dev. 1991;62(1):199–209.CrossRefPubMed
25.
Cassidy J, Shaver PR. Handbook of attachment: theory, research, and clinical applications. 2nd ed. London: Guilford Press; 2008.
26.
Ainsworth MDS, Blehar MC, Waters E, Wall S. Patterns of attachment: a psychological study of the strange situation. London: Wiley; 1978.
27.
Main M, Kaplan N, Cassidy J. Security in infancy, childhood, and adulthood: a move to the level of representation. Monogr Soc Res Child Dev. 1985;50(1/2):66–104.CrossRef
28.
De Wolff M, van Ijzendoorn MH. Sensitivity and attachment: a meta-analysis on parental antecedents of infant attachment. Child Dev. 1997;68(4):571–91.CrossRefPubMed
29.
Slade A, Belsky J, Aber JL, Phelps JL. Mothers’ representations of their relationships with their toddlers: links to adult attachment and observed mothering. Dev Psychol. 1999;36(3):611–9.CrossRef
30.
Slade A, Grienenberger J, Bernbach E, Levy D, Locker A. Maternal reflective functioning, attachment, and the transmission gap: a preliminary study. Attach Hum Dev. 2005;7(3):283–98.CrossRefPubMed
31.
Fonagy P, Bateman A, Bateman A. The widening scope of mentalizing: a discussion. Psychology and Psychotherapy. Psychol Psychother Theory Res Pract. 2011;84(1):98–110.CrossRef
32.
Grienenberger J, Kelly K, Slade A. Maternal reflective functioning, mother-infant affective communication, and infant attachment: exploring the link between mental states and observed caregiving behavior in the intergenerational transmission of attachment. Attach Hum Dev. 2005;7(3):299–311.CrossRefPubMed
33.
Moher DSK, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med. 2001;134:657–62.CrossRefPubMed
34.
Chan A-W TJ, Altman DG, Laupacis A, Gotzsche PC, et al. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.CrossRefPubMedPubMedCentral
35.
Belsky J, Fearon RMP, Bell B. Parenting, attention and externalizing problems: testing mediation longitudinally, repeatedly and reciprocally. J Child Psychol Psychiatry. 2007;48(12):1233–42.CrossRefPubMed
36.
Smith P, Pederson DR. Maternal sensitivity and patterns of infant-mother attachment. Child Dev. 1988;59(4):1097–101.CrossRefPubMed
37.
McElwain N, Booth-LaForce C. Maternal sensitivity to infant distress and nondistress as predictors of infant-mother attachment security. J Fam Psychol. 2006;20(2):247–55.CrossRefPubMed
38.
Biringen Z, Robinson JL, Emde RN. Appendix B: the Emotional Availability Scales (3rd ed.; an abridge Infancy/Early Childhood Version). Attach Hum Dev. 2000;2(2):256–70.CrossRef
39.
Waters E. The Attachment Q-Set. Monogr Soc Res Child Dev. 1995;60(2–3):234–46.CrossRef
40.
van Ijzendoorn M, Vereijken CM, Bakermans-Kranenburg MJ, Riksen-Walraven JM. Assessing attachment security with the Attachment Q Sort: meta-analytic evidence for the validity of the observer AQS. Child Dev. 2004;75(4):1188–213.CrossRefPubMed
41.
Fearon R, Bakermans-Kranenburg MJ, van Ijzendoorn MH, Lapsley AM, Roisman GI. The significance of insecure attachment and disorganization in the development of children’s externalizing behavior: a meta‐analytic study. Child Dev. 2010;81(2):435–56.CrossRefPubMed
42.
Bayley N. Bayley Scales of Infant and Toddler Development. 3rd ed. San Antonio: Harcourt Assessment; 2006.
43.
Marlow N, Wolke D, Bracewell MA, Samara M. Neurologic and developmental disability at six years of age after extremely preterm birth. N Engl J Med. 2005;352:1–11.CrossRef
44.
Achenbach T. Manual for the Child Behavior Checklist/4–18 and 1991 Profile. Burlington: University of Vermont Department of Psychiatry; 1991.
45.
Ivanova M, Achenbach TM, Rescorla LA, Harder VS, Ang RP, Bilenberg N, et al. Preschool psychopathology reported by parents in 23 societies: testing the seven-syndrome model of the child behavior checklist for ages 1.5–5. J Am Acad Child Adolesc Psychiatry. 2010;49(12):1215–24.PubMedPubMedCentral
46.
Cox J, Holden J, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987;150(6):782–6.CrossRefPubMed
47.
Cox J, Chapman G, Murray D, Jones P. Validation of the Edinburgh Postnatal Depression Scale (EPDS) in non-postnatal women. J Affect Disord. 1996;39(3):185–9.CrossRefPubMed
48.
Murray D, Cox JL. Screening for depression during pregnancy with the Edinburgh Depression Scale (EDDS). J Reprod Infant Psychol. 1990;8(2):99–107.CrossRef
49.
Coe C. The development and validation of a measure off parent‐reported child health and morbidity: the Warwick Child Health and Morbidity Profile. Child Care Health Dev. 1996;22(6):367–79.CrossRefPubMed
50.
Byford S, Harrington R, Torgerson D, Kerfoot M, Dyer E, Harrington V, et al. Cost-effectiveness analysis of a home-based social work intervention for children and adolescents who have deliberately poisoned themselves. Results of a randomised controlled trial. Br J Psychiatry. 1999;174:56–62.CrossRefPubMed
51.
Kohnstamm G, Bates J, Rothbart M. Temperament in childhood. Chichester: Wiley; 1989.
52.
53.
54.
DeSocio J, Kitzman H, Cole R. Testing the relationship between self‐agency and enactment of health behavior. Res Nurs Health. 2003;26(1):20–9.CrossRefPubMed
55.
Norbeck J, Lindsey AM, Carrieri VL. The development of an instrument to measure social support. Nurs Res. 1981;30(5):264–9.CrossRefPubMed
56.
Norbeck J, Lindsey AM, Carrieri VL. Further development of the Norbeck Social Support Questionnaire: normative data and validity testing. Nurs Res. 1983;32(1):4–9.CrossRefPubMed
57.
Gigliotti E. A confirmation of the factor structure of the Norbeck Social Support Questionnaire. Nurs Res. 2002;51(5):276–84.CrossRefPubMed
58.
Levy DW, Truman S. Reflective functioning as mediator between drug use, parenting stress and child behaviour. Quebec City: College of Problems of Drug Dependence; 2002.
59.
Slade A. Representation, symbolization and affect regulation in the concomitant treatment of a mother and child: attachment theory and child psychotherapy. Psychoanal Inq. 1999;19:824–57.CrossRef
60.
Aber J, Belsky J, Slade A, Crnic K. Stability and change in mothers’ representations of their relationship with their toddlers. Dev Psychol. 1999;35(4):1038–47.CrossRefPubMed
61.
Abidin R. Parenting Stress Index, third edition: professional manual. Odessa: Psychological Assessment Resources, Inc.; 1995.
62.
Abidin R. Parenting Stress Index (PSI) Manual, Administration Booklet, and Research Update. Charlottesville: Pediatric Psychology Press; 1983.
63.
Weathers F, Litz B, Herman D, Huska J, Keane T. The PTSD Checklist (PCL): reliability, validity, and diagnostic utility. San Antonio: paper presented at the Annual Convention of the International Society for Traumatic Stress Studies; 1993.
64.
Ruggiero K, Del Ben K, Scotti JR, Rabalais AE. Psychometric properties of the PTSD Checklist—Civilian version. J Trauma Stress. 2003;16(5):495–502.CrossRefPubMed
65.
Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. Palo Alto: Consulting Psychologists Press; 1983.
66.
Spielberger CD. State-Trait Anxiety Inventory: a comprehensive bibliography. Palo Alto: Consulting Psychologists Press; 1989.
67.
68.
Cooper P, Murray L, Wilson A, Romaniuk H. Controlled trial of the short and long term effect of psychological treatment of postpartum depression. Br J Psychiatry. 2003;182(5):412–9.CrossRefPubMed
69.
Silove D, Parker G, Manicavasagar V. Perceptions of general and specific therapist behaviors. J Nerv Ment Dis. 1990;178:292–9.CrossRefPubMed
70.
Bakermans-Kranenburg M, IJ Zendoorn MH, van Juffer F. Less is more: meta-analyses of sensitivity and attachment interventions in early childhood. Psychol Bull. 2003;129(2):195–215.CrossRefPubMed
71.
Murray L, Cooper P, Hipwell A. Mental health of parents caring for infants. Arch Womens Ment Health. 2003;6(2):s71–7.CrossRefPubMed
72.
Pocock SJ, Simon R. Sequential Treatment Assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975;31(1):103–15.CrossRefPubMed
73.
Brugha T, Wheatley S, Taub NA, Culverwell A, Friedman T, Kirwan P, Jones DR, Shapiro DA. Pragmatic randomized trial of antenatal intervention to prevent post-natal depression by reducing psychosocial risk factors. Psychol Med. 2000;30(06):1273–81.CrossRefPubMed
74.
Roberts C. The implication of variation in outcome between health professionals for the design and analysis of randomised controlled trials. Stat Med. 1999;18:2605–15.CrossRefPubMed
75.
Sterne JA, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, et al. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ. 2009;338:b2393.CrossRefPubMedPubMedCentral
76.
MacKinnon D, Dwyer JH. Estimating mediated effects in prevention studies. Eval Rev. 1993;17(2):144–58.CrossRef
77.
Preacher K, Hayes AF. Asymptotic and resampling strategies for assessing and comparing indirect effects in multiple mediator models. Behav Res Methods. 2008;40(3):879–91.CrossRefPubMed
78.
McIntosh E, Clarke P, Frew E, Louviere J. Applied methods of cost-benefit analysis in health care. Handbooks in health economic evaluation series. Oxford: Oxford University Press; 2010.
79.
Della Jean D. Reliability and validity of the Emotional Availability Scale among Hispanic and African American mother-toddler dyads. Illinois: Rush University; 2012.
80.
Belfer ML. Child and adolescent mental disorders: the magnitude of the problem across the globe. J Child Psychol Psychiatry. 2008;49(3):226–36.CrossRefPubMed
81.
Wailoo A, Davis S, Tosh J. The incorporation of health benefits in cost utility analysis using the EQ-5D. School of Health and Related Research, University of Sheffield. 2010.
82.
Metadata
Title
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
Authors
Elena Longhi
Lynne Murray
Rachael Hunter
David Wellsted
Samantha Taylor-Colls
Kathryn MacKenzie
Gwynne Rayns
Richard Cotmore
Peter Fonagy
Richard M. Pasco Fearon
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1618-4

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