Promoting Parental Skills and Enhancing Attachment in Early Childhood

Study Overview
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Brief Summary
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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
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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.

Official Title
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Promoting Parental Skills and Enhancing Attachment in Early Childhood

Conditions
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Behavioral Disorders

Intervention / Treatment
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* Behavioral: Promoting Parental Skills and Enhancing Attachment
* Behavioral: had home visits by community workers during pregnancy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Maximum Age: 26 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child mental disorder, Home visit, Postnatal depression, Social Support, Random selection