Evaluation of the French Maternal and Child Protection Services From 11 French Territories That Have Received Common Intervention Guidelines

Study Overview
=================
Brief Summary
-----------------
The PANJO study aims to evaluate, within the French public health services, the impact of a home visitors training on parent-child attachment, families outcomes, use of services and child maltreatment indicators.

Detailed Description
-----------------
In translation

Official Title
-----------------
Evaluation de l'Intervention Des Services de Protection Maternelle et Infantile de 11 départements français Ayant bénéficié d'un référentiel Commun d'Intervention à Domicile (Projet Panjo : Promotion de la Santé et de l'Attachement Des Nouveau-nés et de Leurs Jeunes Parents : un Outil de Renforcement Des Services de PMI)

Conditions
-----------------
Parents, Parent-Child Relations, Maltreatment by Parent, Mental Health Wellness 1

Intervention / Treatment
-----------------
* Other: PANJO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nulliparous Pregnant <32 weeks of amenorrhea Answers yes to the following question: do you feel alone facing the upcoming changes related to your child Exclusion Criteria: Intends to move outside the area in which she can receive the intervention Sees a psychologist or psychiatrist at least once per week Refuses to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PANJO Intervention<br>201 nulliparous women will be recruited within the PMI public services. Nurses/Midwives will propose to enroll in the PANJO group, which consist in receiving 6 to 12 home visits by a home visitor trained by the PANJO team The visits will consist on 45 to 90-minutes interventions aiming at supporting the family in the everyday challenges they may encounter, and to support the development of qualitative parent-child relationships. | Other: PANJO<br>* PANJO consists on a 6 to 12 home visitation intervention aiming at supporting the parents, supporting their upcoming then relationship with their first newbord child and to help them reaching all services they may need.<br>|
| Active Comparator: Service as usual<br>246 nulliparous women will be recruited within several maternity wards. They will recieve the services they may request from (a) the maternities, (b) the maternal and child protection services (PMI, usually 1 or 2 home visit without any standards) or any other service available. They will be provided with the address and telephone of the closest maternity ward. | Other: PANJO<br>* PANJO consists on a 6 to 12 home visitation intervention aiming at supporting the parents, supporting their upcoming then relationship with their first newbord child and to help them reaching all services they may need.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental self-efficacy | 20-item questionnaire parental evaluating parental self efficacy and coercitive behaviors | Child 6th month | 
| Parental Stress Inventory | Subscale parent-child interactions | Child 6th month | 
| Service Use | Use of all social and health services by families | Child 6th month | 
| Accidents | Nb of accidents and accidents leading to hospitalization in children | Child 6th month | 
| Child Maltreatment | Number of services required within the child protection services | Child 6th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pacotis-Parental Impact | Subscale of parental impact self-reported | Child 6th and 12th month | 
| Parental Stress Inventory - Parental Distress | Measure of Parental Distress | Child 6th and 12th month | 
| Knowledge of Infant Development Inventory (KIDI questionnaire) | Measure of Knowledge of Infant Development | Child 6th and 12th month | 
| Edinburgh Postnatal Depression Scale | Measure of depression in mothers | Child 6th and 12th month |