- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03007277
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
Status
Completed
Intervention / Treatment
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.
Collaborators
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.
Clinical Trials on Parent-Child Relations
-
University of LiegeActive, not recruitingParent-Child Relations | Child DevelopmentBelgium
-
McGill UniversitySave the Children; European Network of Foundations Children and Violence Evaluation... and other collaboratorsUnknown
-
University of CalgaryRecruitingParent-Child RelationsCanada
-
University of OttawaRecruitingParent-Child RelationsCanada
-
Universitätsklinikum Hamburg-EppendorfCompleted
-
Penn State UniversityActive, not recruiting
-
VISN 17 Center of ExcellenceUnited States Department of Defense; University of Texas at AustinEnrolling by invitation
-
University of AarhusCompletedParent-Child RelationsDenmark
-
Penn State UniversityCompleted
-
University of Wisconsin, MadisonLoyola University Chicago; Iowa State UniversityCompletedParent-Child Relations