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A home-visiting intervention targeting determinants of infant mental health: the study protocol for the CAPEDP randomized controlled trial in France.
Tubach F., Greacen T., Saïas T., Dugravier R., Guedeney N., Ravaud P., Tereno S., Tremblay R., Falissard B., Guedeney A.
BMC Public Health 12, 1 (2012) 648 - http://www.hal.inserm.fr/inserm-00749189
A home-visiting intervention targeting determinants of infant mental health: the study protocol for the CAPEDP randomized controlled trial in France.
Florence Tubach () 1, 2, Tim Greacen3, Thomas Saïas4, 5, Romain Dugravier6, Nicole Guedeney7, Philippe Ravaud8, 9, Susana Tereno10, Richard Tremblay11, Bruno Falissard12, Antoine Guedeney12, CAPEDP Study Group Collaboration(s)
1 :  Département d'Epidémiologie et Recherche Clinique
Hôpital Bichat - Claude Bernard – Assistance publique - Hôpitaux de Paris (AP-HP)
46 rue Henri Huchard, Secteur Claude Bernard, 75877 Paris Cedex 18
2 :  Centre d'Investigation Clinique - Epidémiologie Clinique
INSERM : CIE801 – Université Paris VII - Paris Diderot – PRES Sorbonne Paris Cité
46, rue Henri Huchard 75877 Paris cedex 18
3 :  Laboratoire de Recherche
Etablissement Public de Santé Maison Blanche
6-10 rue Pierre Bayle 75020 Paris
4 :  Prévention et Education
Institut National de Prévention et d'Éducation de la Santé (INPES)
42, boulevard de la Libération. 93203 Saint-Denis cedex
5 :  Département de psychologie
UQAM - Université du Québec à Montréal
405 rue Sainte-Catherine Street East Montréal, Québec H2L 2C4
6 :  Service de psychopathologie du jeune enfant, de l'enfant et de l'adolescent
Hôpital Bichat - Claude Bernard – Assistance publique - Hôpitaux de Paris (AP-HP)
46, rue Henri-Huchard 75018 Paris
7 :  Département de psychiatrie infanto juvénile
Institut mutualiste Montsouris
42 Boulevard Jourdan 75014 Paris
8 :  Centre d'Epidémiologie Clinique
Hôpital Hôtel Dieu – Assistance publique - Hôpitaux de Paris (AP-HP)
1, place du Parvis de Notre Dame 75181 Paris cedex 4
9 :  Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques
INSERM : U738 – Université Paris VII - Paris Diderot
Faculté de médecine Paris 7 16, Rue Henri Huchard 75018 Paris
10 :  LPPS - Laboratoire de Psychologie et Processus de Santé
Université Paris V - Paris Descartes : EA4057 – Institut de Psychologie – Centre Universitaire de Boulogne-Billancourt – PRES Sorbonne Paris Cité
71, avenue Edouard Vaillant - 92100 Boulogne-Billancourt
11 :  Développement de l'enfant
University College Dublin (UCB)
Stillorgan Rd, Belfield, Dublin 4, Co. Dublin
12 :  Troubles du comportement alimentaire de l'adolescent
INSERM : U669 – Université Paris XI - Paris Sud – Université Paris V - Paris Descartes
Maison de Solene 97, Boulevard de Port Royal 75679 PARIS cedex 14
ABSTRACT: BACKGROUND: Several studies suggest that the number of risk factors rather than their nature is key to mental health disorders in childhood.Method and DesignThe objective of this multicentre randomized controlled parallel trial (PROBE methodology) is to assess the impact in a multi-risk French urban sample of a home-visiting program targeting child mental health and its major determinants. This paper describes the protocol of this study. In the study, pregnant women were eligible if they were: living in the intervention area; able to speak French, less than 26 years old; having their first child; less than 27 weeks of amenorrhea; and if at least one of the following criteria were true: less than twelve years of education, intending to bring up their child without the presence of the child's father, and 3) low income. Participants were randomized into either the intervention or the control group. All had access to usual care in mother-child centres and community mental health services free of charge in every neighbourhood. Psychologists conducted all home visits, which were planned on a weekly basis from the 7th month of pregnancy and progressively decreasing in frequency until the child's second birthday. Principle outcome measures included child mental health at 24 months and two major mediating variables for infant mental health: postnatal maternal depression and the quality of the caring environment. A total of 440 families were recruited, of which a subsample of 120 families received specific attachment and caregiver behaviour assessment. Assessment was conducted by an independent assessment team during home visits and, for the attachment study, in a specifically created Attachment Assessment laboratory. DISCUSSION: The CAPEDP study is the first large-scale randomised, controlled infant mental health promotion programme to take place in France. A major specificity of the program was that all home visits were conducted by specifically trained, supervised psychologists rather than nurses. Significant challenges included designing a mental health promotion programme targeting vulnerable families within one of the most generous but little assessed health and social care systems in the Western World.Trial registrationCurrent Clinical trial number is NCT00392847.
Sciences du Vivant/Santé publique et épidémiologie

Articles dans des revues avec comité de lecture
BMC Public Health (BMC Public Health)
Publisher BioMed Central
ISSN 1471-2458 

Prevention – Mental health promotion – Home visiting Infant mental health – Postnatal depression – Security of attachment and attachment disorganisation in infants – Randomized controlled trial
The study received ethics approval (CPP Paris Saint Louis, advice n° 2006/37) and grants from major funding bodies: CAPEDP was supported by research grants from the French Ministry of Health Programme Hospitalier de Recherche Clinique (PHRC: AOM05056), the Institut National de Prévention et d'Education à la santé (INPES: DAS 08/2006 DAS 018/09 DAS 084/10), the Institut de Recherche en Santé Publique (IReSP: REV0702). The clinical trial number is NCT00392847. The sponsor was the Département à la Recherche Clinique et au Développement, Assistance Publique-Hôpitaux de Paris.
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