Promoting Parental Skills and Enhancing Attachment in Early Childhood

Behavioral Disorders Clinical Trial

— CAPEDP  

Official title:

Promoting Parental Skills and Enhancing Attachment in Early Childhood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00392847
• Other study ID #: P051045
• Status: Completed
• Phase: N/A
• First received: October 17, 2006
• Last updated: July 6, 2012
• Start date: December 2006
• Est. completion date: January 2012

Study information

• Verified date: July 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: January 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 26 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Behavioral Disorders

Intervention

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

Locations

Country	Name	City	State
France	Bichat-Claude Bernard Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (3)

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. French. — View Citation

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 — View Citation

Saïas T, Lerner E, Greacen T, Simon-Vernier E, Emer A, Pintaux E, Guédeney 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 note — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Parental competencies (when the child is 3, 12 and 18 months old)		when the child is 3, 12 and 18 months old	Yes
Primary	Child mental health (when the child is 18 and 24 months old)		when the child is 18 and 24 months old	Yes
Secondary	Child attachment (when the child is 18 months old)		when the child is 18 months old	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Child psychomotor development (when the child is 6, 12 and 24 months old)		when the child is 6, 12 and 24 months old	Yes
Secondary	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	Yes
Secondary	Mother's attachment (at baseline)		at baseline	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes