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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00392847
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : July 10, 2012
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Behavioral Disorders Behavioral: Promoting Parental Skills and Enhancing Attachment Behavioral: had home visits by community workers during pregnancy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Promoting Parental Skills and Enhancing Attachment in Early Childhood
Study Start Date : December 2006
Actual Primary Completion Date : August 2011
Actual Study Completion Date : January 2012

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 Name: to the child's second birthday.




Primary Outcome Measures :
  1. 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 ]
  2. Parental competencies (when the child is 3, 12 and 18 months old) [ Time Frame: when the child is 3, 12 and 18 months old ]
  3. Child mental health (when the child is 18 and 24 months old) [ Time Frame: when the child is 18 and 24 months old ]

Secondary Outcome Measures :
  1. Child attachment (when the child is 18 months old) [ Time Frame: when the child is 18 months old ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. Mother's attachment (at baseline) [ Time Frame: at baseline ]
  8. 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 ]
  9. 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 ]
  10. 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 ]


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Ages Eligible for Study:   up to 26 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392847


Locations
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France
Bichat-Claude Bernard Hospital
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
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Principal Investigator: Antoine Guedeney, PU-PH Assistance Publique - Hôpitaux de Paris
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00392847    
Other Study ID Numbers: P051045
First Posted: October 26, 2006    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Child mental disorder
Home visit
Postnatal depression
Social Support
Random selection
Additional relevant MeSH terms:
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Problem Behavior
Behavioral Symptoms