Promoting Parental Skills and Enhancing Attachment in Early Childhood

Not Applicable

Completed

• Conditions: Behavioral Disorders
• Interventions: Behavioral: Promoting Parental Skills and Enhancing Attachment; Behavioral: had home visits by community workers during pregnancy

• Registration Number: NCT00392847
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2006-10-17
• Study First Submitted QC: 2006-10-25
• Study First Posted: 2006-10-26
• Study Start: 2006-12
• Primary Completion: 2011-08
• Study Completion: 2012-01
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-06
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 440

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Promoting Parental Skills and Enhancing Attachment	The first group will receive routine follow-up as currently provided by national community health and social services.
1	had home visits by community workers during pregnancy	will receive home visits by community workers. These visits will start during pregnancy and will continue up to the child's second birthday.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mother's attachment (at baseline)	at baseline
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
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
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

Trial Locations

Locations (1)

Bichat-Claude Bernard Hospital; 🇫🇷 Paris, France