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

February 18, 2020 updated by: Thomas Saias, L'Agence des Nouvelles Interventions Sociales et de Santé

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)

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.

Study Overview

Detailed Description

In translation

Study Type

Interventional

Enrollment (Actual)

447

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Saint Denis, France, 93203
        • Agence Nationale de Santé Publique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PANJO Intervention
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.
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.
ACTIVE_COMPARATOR: Service as usual
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Thomas Saïas, Ph.D., L'Agence des Nouvelles Interventions Sociales et de Santé

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Saïas, T, Delawarde, C, Colson, S, Planche, M, Vallée, V, Du Roscoät, E, Bonnard, A, Bodard, J, Dugravier, R. De l'expérimentation scientifique à l'implantation dans les services publics : le projet Panjo. Revue Francophone Internationale de Recherche Infirmière, 2 : 232-241, 2016.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (ACTUAL)

February 1, 2019

Study Completion (ACTUAL)

February 1, 2019

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 29, 2016

First Posted (ESTIMATE)

January 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • PANJO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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