Promoting Parental Skills and Enhancing Attachment in Early Childhood

NCT ID: NCT00392847

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Behavioral Disorders

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Child mental disorder Home visit Postnatal depression Social Support Random selection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2

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

Group Type ACTIVE_COMPARATOR

Promoting Parental Skills and Enhancing Attachment

Intervention Type BEHAVIORAL

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

1

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

Group Type EXPERIMENTAL

had home visits by community workers during pregnancy

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Promoting Parental Skills and Enhancing Attachment

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

Intervention Type BEHAVIORAL

had home visits by community workers during pregnancy

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

to the child's second birthday.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Maximum Eligible Age

26 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Antoine Guedeney, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bichat-Claude Bernard Hospital

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 20654860 (View on PubMed)

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.

Reference Type RESULT
PMID: 21782020 (View on PubMed)

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.

Reference Type RESULT
PMID: 22629341 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28236309 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23977257 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22888979 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P051045

Identifier Type: -

Identifier Source: org_study_id