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Open Access 01-12-2018 | Study protocol

Follow-up study regarding the medium-term effectiveness of the home-visiting program “Pro Kind” at age 7 years: study protocol for a randomized controlled trial

Authors: Sören Kliem, Malte Sandner, Anna Lohmann, Susan Sierau, Verena Dähne, Annette M. Klein, Tanja Jungmann

Published in: Trials | Issue 1/2018

Abstract

Background

Pro Kind is a German adaptation of the US Nurse Family Partnership program. It is an intervention based on home visits targeting first-time mothers from disadvantaged populations. Pro Kind was implemented as a randomized control trial from 2006 to 2012 with N = 755 first-time mothers (TG n = 394, CG n = 391). The 7–8-year follow-up aims to assess the mid-term effects of the program.

Methods/design

Mid-term outcomes are being assessed by trained assessors. In a multimethod approach telephone interviews, on-site interviews, observations and developmental tests will be held in order to assess children’s and mothers’ life satisfaction, mental health, cognitive and social development, parenting behavior, signs of child abuse or neglect as well as the family’s socio-economic status. Furthermore, administrative data will be accessed to obtain information regarding the mother’s usage of pediatric health care, welfare usage and employment history.

Discussion

Results regarding the mid-term effects of the intervention from the Pro Kind Follow-up will provide a scientific basis for future primary prevention programs as well as help stakeholders legitimizing early childhood investments.

Trial registration

German Clinical Trial Registration DRKS-ID, ID: DRKS00007554. Registered on 11 June 2015, updated on 6 October 2017.

Available only for authorised users

No odds ratio can be calculated because there was no event in the intervention group. The p-value is based on the relevant percentage points (linear model).

Mikton C, Butchart A. Child maltreatment prevention: a systematic review of reviews. Bull World Health Org. 2009;87:353–61. https://doi.org/10.2471/BLT.08.057075.CrossRefPubMedPubMedCentral

Peacock S, Konrad S, Watson E, Nickel D, Muhajarine N. Effectiveness of home visiting programs on child outcomes: a systematic review. BMC Public Health. 2013;13:17. https://doi.org/10.1186/1471-2458-13-17.CrossRefPubMedPubMedCentral

Sweet MA, Appelbaum MI. Is home visiting an effective strategy? A meta-analytic review of home visiting programs for families with young children. Child Dev. 2004;75:1435–56. https://doi.org/10.1111/j.1467-8624.2004.00750.x.CrossRefPubMed

MacMillan HL, Wathen CN, Barlow J, Fergusson DM, Leventhal JM, Taussig HN. Interventions to prevent child maltreatment and associated impairment. Lancet. 2009;373:250–66. https://doi.org/10.1016/S0140-6736(08)61708-0.CrossRefPubMed

Bilukha O, Hahn RA, Crosby A, Fullilove MT, Liberman A, Moscicki E, et al. The effectiveness of early childhood home visitation in preventing violence: a systematic review. Am J Prev Med. 2005;28:11–39. https://doi.org/10.1016/j.amepre.2004.10.004.CrossRefPubMed

Avellar SA, Supplee LH. Effectiveness of home visiting in improving child health and reducing child maltreatment. Pediatrics. 2013;132(Suppl 2):S90–9. https://doi.org/10.1542/peds.2013-1021G.CrossRefPubMed

Kendrick D. Does home visiting improve parenting and the quality of the home environment?: a systematic review and meta analysis. Arch Dis Child. 2000;82:443–51. https://doi.org/10.1136/adc.82.6.443.CrossRefPubMedPubMedCentral

Euser S, Alink LR, Stoltenborgh M, Bakermans-Kranenburg MJ, van IJzendoorn MH. A gloomy picture: a meta-analysis of randomized controlled trials reveals disappointing effectiveness of programs aiming at preventing child maltreatment. BMC Public Health. 2015;15:1068. https://doi.org/10.1186/s12889-015-2387-9.CrossRefPubMedPubMedCentral

Kamerman SB, Kahn AJ. Home health visiting in Europe. Future Child (Future Child). 1993;3:39. https://doi.org/10.2307/1602542.CrossRef

10.

Olds DL. The nurse-family partnership: an evidence-based preventive intervention. Infant Ment Health J. 2006;27(1):5–25. https://doi.org/10.1002/imhj.20077.

11.

Eckenrode J, Ganzel B, Henderson CR, Smith E, Olds DL, Powers J, et al. Preventing child abuse and neglect with a program of nurse home visitation: the limiting effects of domestic violence. JAMA. 2000;284:1385–91.CrossRefPubMed

12.

Eckenrode J, Campa M, Luckey DW, Henderson CR, Cole R, Kitzman H, et al. Long-term effects of prenatal and infancy nurse home visitation on the life course of youths: 19-year follow-up of a randomized trial. Arch Pediatr Adolesc Med. 2010;164:9–15. https://doi.org/10.1001/archpediatrics.2009.240.CrossRefPubMed

13.

Kitzman H, Olds DL, Henderson 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

14.

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 randomized trial. JAMA. 2000;283:1983–9.CrossRefPubMed

15.

Kitzman HJ, Olds DL, Cole RE, Hanks CA, Anson EA, Arcoleo KJ, et al. Enduring effects of prenatal and infancy home visiting by nurses on children: follow-up of a randomized trial among children at age 12 years. Arch Pediatr Adolesc Med. 2010;164:412–8. https://doi.org/10.1001/archpediatrics.2010.76.CrossRefPubMedPubMedCentral

16.

Olds D, Henderson CR, Cole R, Eckenrode J, Kitzman H, Luckey D, et al. Long-term effects of nurse home visitation on children’s criminal and antisocial behavior: 15-year follow-up of a randomized controlled trial. JAMA. 1998;280:1238–44.CrossRefPubMed

17.

Olds DL, Eckenrode J, Henderson CR, Kitzman H, Powers J, Cole R, et al. Long-term effects of home visitation on maternal life course and child abuse and neglect. Fifteen-year follow-up of a randomized trial. JAMA. 1997;278:637–43.CrossRefPubMed

18.

Olds DL, Henderson CR, Chamberlin R, Tatelbaum R. Preventing child abuse and neglect: a randomized trial of nurse home visitation. Pediatrics. 1986;78:65–78.PubMed

19.

Olds DL, Henderson CR, Kitzman H. Does prenatal and infancy nurse home visitation have enduring effects on qualities of parental caregiving and child health at 25 to 50 months of life? Pediatrics. 1994;93:89–98.PubMed

20.

Olds DL, Kitzman H, Cole R, Robinson J, Sidora K, Luckey DW, et al. Effects of nurse home-visiting on maternal life course and child development: age 6 follow-up results of a randomized trial. Pediatrics. 2004;114:1550–9. https://doi.org/10.1542/peds.2004-0962.CrossRefPubMed

21.

Olds DL, Kitzman H, Hanks C, Cole R, Anson E, Sidora-Arcoleo K, et al. Effects of nurse home visiting on maternal and child functioning: Age-9 follow-up of a randomized trial. Pediatrics. 2007;120:e832–45. https://doi.org/10.1542/peds.2006-2111.CrossRefPubMedPubMedCentral

22.

Olds DL, Kitzman H, Knudtson MD, Anson E, Smith JA, Cole R. Effect of home visiting by nurses on maternal and child mortality: results of a 2-decade follow-up of a randomized clinical trial. JAMA Pediatr. 2014;168:800–6. https://doi.org/10.1001/jamapediatrics.2014.472.CrossRefPubMedPubMedCentral

23.

Olds DL, Kitzman HJ, Cole RE, Hanks CA, Arcoleo KJ, Anson EA, et al. Enduring effects of prenatal and infancy home visiting by nurses on maternal life course and government spending: follow-up of a randomized trial among children at age 12 years. Arch Pediatr Adolesc Med. 2010;164:419–24. https://doi.org/10.1001/archpediatrics.2010.49.CrossRefPubMedPubMedCentral

24.

Olds DL, 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;110:486–96.CrossRefPubMed

25.

Olds DL, Robinson J, Pettitt L, Luckey DW, Holmberg J, Ng RK, et al. Effects of home visits by paraprofessionals and by nurses: age 4 follow-up results of a randomized trial. Pediatrics. 2004;114:1560–8. https://doi.org/10.1542/peds.2004-0961.CrossRefPubMed

26.

Zielinski DS, Eckenrode J, Olds DL. Nurse home visitation and the prevention of child maltreatment: impact on the timing of official reports. Dev Psychopathol. 2009;21:441–53. https://doi.org/10.1017/S0954579409000248.CrossRefPubMed

27.

Eckenrode J, Ganzel B, Henderson JCR, Smith E, Olds DL, Powers J, et al. Preventing child abuse and neglect with a program of nurse home visitation. JAMA. 2000;284:1385. https://doi.org/10.1001/jama.284.11.1385.CrossRefPubMed

28.

Kitzman H. Effect of prenatal and infancy home visitation by nurses on pregnancy outcomes, childhood injuries, and repeated childbearing. JAMA. 1997;278:644. https://doi.org/10.1001/jama.1997.03550080054039.CrossRefPubMed

29.

Kitzman H, Olds DL, Sidora K, Henderson JCR, Hanks C, Cole R, et al. Enduring effects of nurse home visitation on maternal life course. JAMA. 2000;283:1983. https://doi.org/10.1001/jama.283.15.1983.CrossRefPubMed

30.

Olds D, Henderson JCR, Cole R, Eckenrode J, Kitzman H, Luckey D, et al. Long-term effects of nurse home visitation on children’s criminal and antisocial behavior. JAMA. 1998;280:1238. https://doi.org/10.1001/jama.280.14.1238.CrossRefPubMed

31.

Miller TR. Projected outcomes of nurse-family partnership home visitation during 1996-2013. USA Prev Sci. 2015;16:765–77. https://doi.org/10.1007/s11121-015-0572-9+. CrossRefPubMed

32.

Karoly LA, Cannon JS, Kilburn MR. Early childhood interventions: proven results, future promise. Santa Monica: Rand; 2005.CrossRef

33.

Lee S, Aos S, Miller MG. Evidence-based programs to prevent children from entering and remaining in the child welfare system: benefits and costs for Washington. Olympia: Washington State Institute for Public Policy; 2008.

34.

Olds DL, Henderson CR, Phelps C, Kitzman H, Hanks C. Effect of prenatal and infancy nurse home visitation on government spending. Med Care. 1993;31:155–74.CrossRefPubMed

35.

Jack SM, Sheehan D, Gonzalez A, MacMillan HL, Catherine N, Waddell C. British Columbia healthy connections project process evaluation: a mixed methods protocol to describe the implementation and delivery of the nurse-family partnership in Canada. BMC Nurs. 2015;14:47. https://doi.org/10.1186/s12912-015-0097-3.CrossRefPubMedPubMedCentral

36.

Tubach F, Greacen T, Saïas T, Dugravier R, Guedeney N, Ravaud P, et al. A home-visiting intervention targeting determinants of infant mental health: the study protocol for the CAPEDP randomized controlled trial in France. BMC Public Health. 2012;12:648. https://doi.org/10.1186/1471-2458-12-648.CrossRefPubMedPubMedCentral

37.

Mejdoubi J, van den Heijkant SCCM, van Leerdam FJM, Crone M, Crijnen A, HiraSing RA. Effects of nurse home visitation on cigarette smoking, pregnancy outcomes and breastfeeding: a randomized controlled trial. Midwifery. 2014;30:688–95. https://doi.org/10.1016/j.midw.2013.08.006.CrossRefPubMed

38.

Mejdoubi J, van den Heijkant SCCM, van Leerdam FJM, Heymans MW, Crijnen A, HiraSing RA. The effect of VoorZorg, the Dutch nurse-family partnership, on child maltreatment and development: a randomized controlled trial. PLoS One. 2015;10:e0120182. https://doi.org/10.1371/journal.pone.0120182.CrossRefPubMedPubMedCentral

39.

Mejdoubi J, van den Heijkant SCCM, van Leerdam FJM, Heymans MW, HiraSing RA, Crijnen AAM. Effect of nurse home visits vs. usual care on reducing intimate partner violence in young high-risk pregnant women: a randomized controlled trial. PLoS One. 2013;8:e78185. https://doi.org/10.1371/journal.pone.0078185.CrossRefPubMedPubMedCentral

40.

Robling M, Bekkers M-J, Bell K, Butler CC, Cannings-John R, Channon S, et al. Effectiveness of a nurse-led intensive home-visitation programme for first-time teenage mothers (building blocks): a pragmatic randomised controlled trial. Lancet. 2016;387:146–55. https://doi.org/10.1016/S0140-6736(15)00392-X.CrossRefPubMedPubMedCentral

41.

Prevention Research Center for Family and Child Health. Nurse-family partnership international program. 2014 http://www.ucdenver.edu/academics/colleges/medicalschool/departments/pediatrics/research/programs/prc/research/international/Pages/international.aspx. Accessed 23 Jun 2017.

42.

Brand T, Jungmann T. Implementation differences of two staffing models in the German home-visiting program Pro-Kind. J Community Psychol. 2012;40:891–905. https://doi.org/10.1002/jcop.21489.CrossRef

43.

Sierau S, Dähne V, Brand T, Kurtz V, von Klitzing K, Jungmann T. Effects of home visitation on maternal competencies, family environment, and child development: a randomized controlled trial. Prev Sci. 2016;17:40–51. https://doi.org/10.1007/s11121-015-0573-8.CrossRefPubMed

44.

Brand T, Jungmann T. Participant characteristics and process variables predict attrition from a home-based early intervention program. Early Child Res Q. 2014;29:155–67. https://doi.org/10.1016/j.ecresq.2013.12.001.CrossRef

45.

Sandner M, Jungmann T. Gender-specific effects of early childhood intervention: evidence from a randomized controlled trial. Labour Econ. 2017:59–78.

46.

Sandner M. Effects of early childhood intervention on fertility and maternal employment: Evidence from a randomized controlled trial. University of Chicago: HCEO Working Paper.-74; 2017.

47.

Sandner M, Cornelissen T, Jungmann T, Herrmann P. Evaluating the effects of a home visiting programme for at-risk mothers during pregnancy on mother and child health outcomes. J Health Econ. 2018;58:269–83.

48.

Meier-Pfeiffer A, Kutz K, Kosten SM. Nutzen und Finanzierung der Frühen Hilfen. In: Brand T, Jungmann T, editors. Kinder schützen, Familien stärken. Erfahrungen und Empfehlungen für die Ausgestaltung Früher Hilfen aus der Pro Kind Praxis und –Forschung. Weinheim: Beltz Juventa; 2013. p. 111–24.

49.

Siedler T, Schupp J, Spiess CK, Wagner GG. The German socio-economic panel (SOEP) as reference data set. Schmollers Jahr. 2009:367–74.

50.

Kamtsiuris P, Lange M, Schaffrath Rosario A. Der Kinder- und Jugendgesundheitssurvey (KiGGS): Stichprobendesign, Response und Nonresponse-Analyse. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2007;50:547–56. https://doi.org/10.1007/s00103-007-0215-9.CrossRefPubMed

51.

Wittchen H-U, Lachner G, Wunderlich U, Pfister H. Test-retest reliability of the computerized DSM-IV version of the Munich-composite international diagnostic interview (M-CIDI). Soc Psychiatry Psychiatr Epidemiol. 1998;33:568–78. https://doi.org/10.1007/s001270050095.CrossRefPubMed

52.

Schneider S, Margraf J. DIPS: Diagnostisches Interview bei psychischen Störungen. 4th ed. Berlin: Springer-Verlag Berlin Heidelberg; 2011.CrossRef

53.

Kantor GK, Holt MK, Mebert CJ, Straus MA, Drach KM, Ricci LR, et al. Development and preliminary psychometric properties of the multidimensional neglectful behavior scale-child report. Child Maltreat. 2004;9:409–28. https://doi.org/10.1177/1077559504269530.CrossRefPubMed

54.

Straus MA, Hamby SL, Boney-McCoy SUE, Sugarman DB. The revised conflict tactics scales (CTS2). J Fam Issues. 1996;17:283–316. https://doi.org/10.1177/019251396017003001.CrossRef

55.

Esser G, Wyschkon A, Balaschk K. BUEGA Basisdiagnostik Umschriebener Entwicklungsstörungen im Grundschulalter. Göttingen: Hogrefe; 2008.

56.

Dohmen T, Falk A, Huffman D, Sunde U, Schupp J, Wagner GG. Individual risk attitudes: Measurement, determinants, and behavioral consequences. J Eur Econ Assoc. 2011;9:522–50. https://doi.org/10.1111/j.1542-4774.2011.01015.x. CrossRef

57.

Fehr E, Bernhard H, Rockenbach B. Egalitarianism in young children. Nature. 2008;454:1079–83. https://doi.org/10.1038/nature07155;.CrossRefPubMed

58.

Mischel W, Shoda Y, Rodriguez M. Delay of gratification in children. Science. 1989;244:933–8. https://doi.org/10.1126/science.2658056.CrossRefPubMed

59.

Bradley RH, Caldwell BM, Rock SL, Hamrick HM, Harris P. Home observation for measurement of the environment: development of a home inventory for use with families having children 6 to 10 years old. Contemp Educ Psychol. 1988;13:58–71. https://doi.org/10.1016/0361-476X(88)90006-9.CrossRef

60.

Achenbach TM, Rescorla LA. Manual for ASEBA school-age forms and profiles. Burlington: University of Vermont, Research Center for Children, Youth, and Families; 2001.

61.

Döpfner M, Plück J, Kinnen C, Arbeitsgruppe Deutsche Child Behavior Checklist. CBCL Handbuch-Schulalter. Manual zum Elternfragebogen über das Verhalten von Kindern und Jugendlichen. (CBCL/6-18R), zum Lehrerfragebogen über das Verhalten von Kindern und Jugendlichen (TRF/6-18R) und zum Fragebogen für Jugendliche (YSR/11-18R). Göttingen: Hogrefe; 2014.

62.

Elliot SN, Gresham FM. Social skills improvement system. Minneapolis: Pearson Assessments; 2008.

63.

Görtz-Dorten A, Döpfner M. Fragebogen zum aggressiven Verhalten von Kindern. Göttingen: Hogrefe; 2010.

64.

Essau CA, Sasagawa S, Frick PJ. Callous-unemotional traits in a community sample of adolescents. Assessment. 2006;13:454–69. https://doi.org/10.1177/1073191106287354.CrossRefPubMed

65.

Mattejat F, Remschmidt H. ILK: Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen. München: Huber; 2006.

66.

Arnold DS, O’Leary SG, Wolff LS, Acker MM. The parenting scale: a measure of dysfunctional parenting in discipline situations. Psychol Assess. 1993;5:137–44. https://doi.org/10.1037/1040-3590.5.2.137.CrossRef

67.

Straus MA, Hamby SL, Finkelhor D, Moore DW, Runyan D. Identification of child maltreatment with the parent-child conflict tactics scales: development and psychometric data for a National Sample of American parents. Child Abuse Negl. 1998;22:249–70. https://doi.org/10.1016/S0145-2134(97)00174-9.CrossRefPubMed

68.

Sierau S, White LO, Klein AM, Klitzing K von, Herzberg PY. Assessing physical abuse from children’s perspective: Factor structure, measurement invariance, and validity of the Child-report Abusive Parenting Scales (CAPS). submitted for publication; 2017.

69.

Straus MA, Kinard EM, Williams LM. The multidimensional neglectful behavior scale, Form A: Adolescent and adult-recall version. 1995. https://www.researchgate.net/publication/228920879_The_multidimensional_neglectful_behavior_scale_Form_A_Adolescent_and_adult-recall_version.

70.

Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the depression anxiety stress scales (DASS) with the Beck depression and anxiety inventories. Behav Res Ther. 1995;33:335–43. https://doi.org/10.1016/0005-7967(94)00075-U.CrossRefPubMed

71.

Kliem S, Mößle T, Rehbein F, Hellmann DF, Zenger M, Brähler E. A brief form of the perceived social support questionnaire (F-SozU) was developed, validated, and standardized. J Clin Epidemiol. 2015;68:551–62. https://doi.org/10.1016/j.jclinepi.2014.11.003.CrossRefPubMed

72.

Abidin RR. Parenting stress index (PSI). Charlottesville: Pediatric Psychology Press; 1990.

73.

Tröster H. Eltern-Belastungs-Inventar: EBI; deutsche Version des Parenting Stress Index (PSI) von RR Abidin. Göttingen: Hogrefe; 2011.

74.

Kliem S, Job A-K, Kröger C, Bodenmann G, Stöbel-Richter Y, Hahlweg K, Brähler E. Entwicklung und Normierung einer Kurzform des Partnerschaftsfragebogens (PFB-K) an einer repräsentativen deutschen Stichprobe. Z Klin Psychol Psychother. 2012;41:81–9. https://doi.org/10.1026/1616-3443/a000135.CrossRef

75.

Kliem S, Foran HM, Beller J, Hahlweg K, Stöbel-Richter Y, Brähler E. Dimensional latent structure of relationship quality: results of three representative population samples. Fam Relat. 2015;77:1190–201. https://doi.org/10.1111/jomf.12211.CrossRef

76.

Ohan JL, Leung DW, Johnston C. The parenting sense of competence scale: evidence of a stable factor structure and validity. Can J Behav Sci. 2000;32:251–61. https://doi.org/10.1037/h0087122.CrossRef

77.

Fahrenberg J, Myrtek M, Schumacher J. Fragebogen zur Lebenszufriedenheit (FLZ)Handanweisung, Fragebogen, Auswertungsbogen. Göttingen: Hogrefe; 2000.

78.

Trappmann M, Gundert S, Wenzig C, Gebhardt D. PASS–A household panel survey for research on unemployment and poverty. Schmollers Jahr. 2010;130:609–22.CrossRef

79.

Andersen HH, Mühlbacher A, Nübling M, Schupp J, Wagner GG. Computation of standard values for physical and mental health scale scores using the SOEP version of SF-12. Schmollers Jahr. 2007;127(1):171–82.

80.

Kurth B-M. Der Kinder- und Jugendgesundheitssurvey (KiGGS): Ein Überblick über Planung, Durchführung und Ergebnisse unter Berücksichtigung von Aspekten eines Qualitätsmanagements. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2007;50:533–46. https://doi.org/10.1007/s00103-007-0214-x.CrossRefPubMed

81.

Taubner S, Munder T, Unger A, Wolter S. Zur Wirksamkeit präventiver Früher Hilfen in Deutschland - ein systematisches Review und eine Metaanalyse. Prax Kinderpsychol Kinderpsychiatr. 2013;62:598–619. https://doi.org/10.13109/prkk.2013.62.8.598.CrossRefPubMed

Title: Follow-up study regarding the medium-term effectiveness of the home-visiting program “Pro Kind” at age 7 years: study protocol for a randomized controlled trial
Authors: Sören Kliem
Malte Sandner
Anna Lohmann
Susan Sierau
Verena Dähne
Annette M. Klein
Tanja Jungmann
Publication date: 01-12-2018
Publisher: BioMed Central
Published in: Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-018-2707-3

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Follow-up study regarding the medium-term effectiveness of the home-visiting program “Pro Kind” at age 7 years: study protocol for a randomized controlled trial

Abstract

Background

Methods/design

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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