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Clinical Trials/NCT00392847
NCT00392847
Completed
Not Applicable

Promoting Parental Skills and Enhancing Attachment in Early Childhood

Assistance Publique - Hôpitaux de Paris1 site in 1 country440 target enrollmentDecember 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Behavioral Disorders
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
440
Locations
1
Primary Endpoint
Mothers' scores on a postnatal depression scale (baseline, and when the child is 3, 6 and 12 months old)
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2006
End Date
January 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

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

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

Time Frame: 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

Secondary Outcomes

  • Child psychomotor development (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)(baseline, and when the child is 3 and 24 months old)
  • 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)
  • Mother's attachment (at baseline)(at baseline)
  • Mother's mental health (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)(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)(baseline, and when the child is 3, 6, 12, 18 and 24 months old)

Study Sites (1)

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