Promoting Parental Skills and Enhancing Attachment in Early Childhood (CAPEDP)

July 6, 2012 updated by: Assistance Publique - Hôpitaux de Paris
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75018
        • Bichat-Claude Bernard Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 26 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
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
The first group will receive routine follow-up as currently provided by national community health and social services.
Experimental: 1
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
had home visits by community workers during pregnancy to the child's second birthday.
Other Names:
  • to the child's second birthday.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mothers' scores on a postnatal depression scale (baseline, and when the child is 3, 6 and 12 months old)
Time Frame: 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)
Time Frame: 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)
Time Frame: when the child is 18 and 24 months old
when the child is 18 and 24 months old

Secondary Outcome Measures

Outcome Measure
Time Frame
Child attachment (when the child is 18 months old)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: when the child is 6, 12 and 24 months old
when the child is 6, 12 and 24 months old
Mother's knowledge about child development (baseline, and when the child is 3 and 24 months old)
Time Frame: baseline, and when the child is 3 and 24 months old
baseline, and when the child is 3 and 24 months old
Mother's attachment (at baseline)
Time Frame: at baseline
at baseline
Mother's mental health (baseline, and when the child is 3 and 24 months old)
Time Frame: baseline, and when the child is 3 and 24 months old
baseline, and when the child is 3 and 24 months old
Mother's working alliance with home visitor (not for control group) (when the child is 3, 6, 12 and 24 months old)
Time Frame: not for control group,when the child is 3, 6, 12 and 24 months old
not for control group,when the child is 3, 6, 12 and 24 months old
Social-demographic data (all follow-up points: baseline, and when the child is 3, 6, 12, 18 and 24 months old)
Time Frame: baseline, and when the child is 3, 6, 12, 18 and 24 months old
baseline, and when the child is 3, 6, 12, 18 and 24 months old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Antoine Guedeney, PU-PH, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

October 17, 2006

First Submitted That Met QC Criteria

October 25, 2006

First Posted (Estimate)

October 26, 2006

Study Record Updates

Last Update Posted (Estimate)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 6, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P051045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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