NCT00392847

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2006

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 26, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

4.7 years

First QC Date

October 17, 2006

Last Update Submit

July 6, 2012

Conditions

Behavioral Disorders

Keywords

Child mental disorderHome visitPostnatal depressionSocial SupportRandom selection

Outcome Measures

Primary Outcomes (3)

  • Mothers' scores on a postnatal depression scale (baseline, and when the child is 3, 6 and 12 months old)

    baseline, and when the child is 3, 6 and 12 months old

  • Parental competencies (when the child is 3, 12 and 18 months old)

    when the child is 3, 12 and 18 months old

  • Child mental health (when the child is 18 and 24 months old)

    when the child is 18 and 24 months old

Secondary Outcomes (10)

  • Child attachment (when the child is 18 months old)

    when the child is 18 months old

  • Family use of medical and social services (baseline, and when the child is 3, 6, 12 and 24 months old)

    baseline, and when the child is 3, 6, 12 and 24 months old

  • Family social support (baseline, and when the child is 3, 12 and 24 months old)

    baseline, and when the child is 3, 12 and 24 months old

  • Mother's self-esteem as a parent (when the child is 3, 12 and 24 months old)

    when the child is 3, 12 and 24 months old

  • Child psychomotor development (when the child is 6, 12 and 24 months old)

    when the child is 6, 12 and 24 months old

  • +5 more secondary outcomes

Study Arms (2)

2

ACTIVE COMPARATOR

The first group will receive routine follow-up as currently provided by national community health and social services.

Behavioral: Promoting Parental Skills and Enhancing Attachment

1

EXPERIMENTAL

will receive home visits by community workers. These visits will start during pregnancy and will continue up to the child's second birthday.

Behavioral: had home visits by community workers during pregnancy

Interventions

Promoting Parental Skills and Enhancing AttachmentBEHAVIORAL

The first group will receive routine follow-up as currently provided by national community health and social services.

2
had home visits by community workers during pregnancyBEHAVIORAL

had home visits by community workers during pregnancy to the child's second birthday.

Also known as: to the child's second birthday.
1

Eligibility Criteria

AgeUp to 26 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bichat-Claude Bernard Hospital

Paris, 75018, France

Location

Related Publications (6)

  • 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.

    PMID: 20654860RESULT

  • 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.

    PMID: 21782020RESULT

  • 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.

    PMID: 22629341RESULT

  • 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.

    PMID: 28236309DERIVED

  • 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.

    PMID: 23977257DERIVED

  • 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.

    PMID: 22888979DERIVED

MeSH Terms

Conditions

Mental DisordersNeurodevelopmental DisordersDepression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood Disorders

Study Officials

  • Antoine Guedeney, PU-PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 26, 2006

Study Start

December 1, 2006

Primary Completion

August 1, 2011

Study Completion

January 1, 2012

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

FR(1)