Clinical trial NCT00392847: Promoting Parental Skills and Enhancing Attachment in Early Childhood
Official title: Promoting Parental Skills and Enhancing Attachment in Early Childhood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral Disorders
Keywords: Child mental disorder
Home visit
Postnatal depression
Social Support
Random selection
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2006-10-26
Enrollment: 440
Sex: FEMALE
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Child psychological/behavioural disorders such as withdrawal may persist when the psychosocial context is unfavourable. Health promotion strategies (Olds' paradigm) have proved their efficacy in vulnerable populations. CAPEDP project sets out to evaluate a program of home visits in France

Detailed description: This program aims at reducing psychosocial disorders and promoting mental health, social support and attachment amongst at-risk young women and their family. 440 primigravida (pregnant women) will be randomised into two groups. The first group will receive routine follow-up as currently provided by national community health and social services. The second group will receive home visits by community workers. These visits will start during pregnancy and will continue up to the child's second birthday.

Eligibility criteria: Inclusion Criteria:

* Being less than 26 years old
* Being pregnant for less than 27 weeks
* Being primiparous
* Living in the study area
* Being socially vulnerable: less than 12 years of education AND/OR socially isolated AND/OR eligible for a public health insurance for people with low resources.

Exclusion Criteria:

* Refusal to participate
* Not able to speak French
* Having a medical follow-up which necessitates regular contact with health professional
* Not having health insurance
* Persons for whom follow up at 27 months is impossible (evaluation at baseline)

Primary outcomes:
measure: Mothers' scores on a postnatal depression scale (baseline, and when the child is 3, 6 and 12 months old)
timeFrame: baseline, and when the child is 3, 6 and 12 months old
measure: Parental competencies (when the child is 3, 12 and 18 months old)
timeFrame: when the child is 3, 12 and 18 months old
measure: Child mental health (when the child is 18 and 24 months old)
timeFrame: when the child is 18 and 24 months old
Secondary outcomes:
measure: Child attachment (when the child is 18 months old)
timeFrame: when the child is 18 months old
measure: Family use of medical and social services (baseline, and when the child is 3, 6, 12 and 24 months old)
timeFrame: baseline, and when the child is 3, 6, 12 and 24 months old
measure: Family social support (baseline, and when the child is 3, 12 and 24 months old)
timeFrame: baseline, and when the child is 3, 12 and 24 months old
measure: Mother's self-esteem as a parent (when the child is 3, 12 and 24 months old)
timeFrame: when the child is 3, 12 and 24 months old
measure: Child psychomotor development (when the child is 6, 12 and 24 months old)
timeFrame: when the child is 6, 12 and 24 months old
measure: Mother's knowledge about child development (baseline, and when the child is 3 and 24 months old)
timeFrame: baseline, and when the child is 3 and 24 months old
measure: Mother's attachment (at baseline)
timeFrame: at baseline
measure: Mother's mental health (baseline, and when the child is 3 and 24 months old)
timeFrame: baseline, and when the child is 3 and 24 months old
measure: Mother's working alliance with home visitor (not for control group) (when the child is 3, 6, 12 and 24 months old)
timeFrame: not for control group,when the child is 3, 6, 12 and 24 months old
measure: Social-demographic data (all follow-up points: baseline, and when the child is 3, 6, 12, 18 and 24 months old)
timeFrame: baseline, and when the child is 3, 6, 12, 18 and 24 months old
Other outcomes:
Locations:
city: Paris
country: France
facility: Bichat-Claude Bernard Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Antoine Guedeney, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dugravier R. [Understanding consequences of hospitalization within attachment theory]. Arch Pediatr. 2010 Jun;17(6):723-4. doi: 10.1016/S0929-693X(10)70078-6. No abstract available. French.
citation: Guedeney A, Guedeney N, Tereno S, Dugravier R, Greacen T, Welniarz B, Saias T, Tubach F; CAPEDP Study Group. Infant rhythms versus parental time: promoting parent-infant synchrony. J Physiol Paris. 2011 Dec;105(4-6):195-200. doi: 10.1016/j.jphysparis.2011.07.005. Epub 2011 Jul 12.
citation: Saias T, Lerner E, Greacen T, Simon-Vernier E, Emer A, Pintaux E, Guedeney A, Dugravier R, Tereno S, Falissard B, Tubach F; CAPEDP Study Group; Revah-Levy A. Evaluating fidelity in home-visiting programs a qualitative analysis of 1058 home visit case notes from 105 families. PLoS One. 2012;7(5):e36915. doi: 10.1371/journal.pone.0036915. Epub 2012 May 18.
citation: Greacen T, Welniarz B, Purper-Ouakil D, Wendland J, Dugravier R, Saias T, Tereno S, Tubach F, Haddad A, Guedeney A; CAPEDP STUDY GROUP. BEST PRACTICE IN INDIVIDUAL SUPERVISION OF PSYCHOLOGISTS WORKING IN THE FRENCH CAPEDP PREVENTIVE PERINATAL HOME-VISITING PROGRAM: RESULTS OF A DELPHI CONSENSUS PROCESS. Infant Ment Health J. 2017 Mar;38(2):267-275. doi: 10.1002/imhj.21630. Epub 2017 Feb 25.
citation: Dugravier R, Tubach F, Saias T, Guedeney N, Pasquet B, Purper-Ouakil D, Tereno S, Welniarz B, Matos J; CAPEDP Study Group; Guedeney A, Greacen T. Impact of a manualized multifocal perinatal home-visiting program using psychologists on postnatal depression: the CAPEDP randomized controlled trial. PLoS One. 2013 Aug 19;8(8):e72216. doi: 10.1371/journal.pone.0072216. eCollection 2013.
citation: Tubach F, Greacen T, Saias T, Dugravier R, Guedeney N, Ravaud P, Tereno S, Tremblay R, Falissard B, Guedeney A; CAPEDP Study Group. 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 Aug 13;12:648. doi: 10.1186/1471-2458-12-648.