<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03007277</url>
  </required_header>
  <id_info>
    <org_study_id>PANJO</org_study_id>
    <nct_id>NCT03007277</nct_id>
  </id_info>
  <brief_title>Evaluation of the French Maternal and Child Protection Services From 11 French Territories That Have Received Common Intervention Guidelines</brief_title>
  <acronym>PANJO</acronym>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>L'Agence des Nouvelles Interventions Sociales et de Santé</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut national de prevention et d'education pour la sante</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Université du Québec a Montréal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>L'Agence des Nouvelles Interventions Sociales et de Santé</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The PANJO study aims to evaluate, within the French public health services, the impact of a&#xD;
      home visitors training on parent-child attachment, families outcomes, use of services and&#xD;
      child maltreatment indicators.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In translation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">February 2019</completion_date>
  <primary_completion_date type="Actual">February 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Parental self-efficacy</measure>
    <time_frame>Child 6th month</time_frame>
    <description>20-item questionnaire parental evaluating parental self efficacy and coercitive behaviors</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parental Stress Inventory</measure>
    <time_frame>Child 6th month</time_frame>
    <description>Subscale &quot;parent-child interactions&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Service Use</measure>
    <time_frame>Child 6th month</time_frame>
    <description>Use of all social and health services by families</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accidents</measure>
    <time_frame>Child 6th month</time_frame>
    <description>Nb of accidents and accidents leading to hospitalization in children</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child Maltreatment</measure>
    <time_frame>Child 6th month</time_frame>
    <description>Number of services required within the child protection services</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pacotis-Parental Impact</measure>
    <time_frame>Child 6th and 12th month</time_frame>
    <description>Subscale of parental impact self-reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental Stress Inventory - Parental Distress</measure>
    <time_frame>Child 6th and 12th month</time_frame>
    <description>Measure of Parental Distress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge of Infant Development Inventory (KIDI questionnaire)</measure>
    <time_frame>Child 6th and 12th month</time_frame>
    <description>Measure of Knowledge of Infant Development</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Edinburgh Postnatal Depression Scale</measure>
    <time_frame>Child 6th and 12th month</time_frame>
    <description>Measure of depression in mothers</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">447</enrollment>
  <condition>Parent-Child Relations</condition>
  <condition>Maltreatment by Parent</condition>
  <condition>Parents</condition>
  <condition>Mental Health Wellness 1</condition>
  <arm_group>
    <arm_group_label>PANJO Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Service as usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PANJO</intervention_name>
    <description>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.</description>
    <arm_group_label>PANJO Intervention</arm_group_label>
    <arm_group_label>Service as usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nulliparous&#xD;
&#xD;
          -  Pregnant &lt;32 weeks of amenorrhea&#xD;
&#xD;
          -  Answers yes to the following question: &quot;do you feel alone facing the upcoming changes&#xD;
             related to your child&quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intends to move outside the area in which she can receive the intervention&#xD;
&#xD;
          -  Sees a psychologist or psychiatrist at least once per week&#xD;
&#xD;
          -  Refuses to participate&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Saïas, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>L'Agence des Nouvelles Interventions Sociales et de Santé</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Agence Nationale de Santé Publique</name>
      <address>
        <city>Saint Denis</city>
        <zip>93203</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>February 18, 2020</last_update_submitted>
  <last_update_submitted_qc>February 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>L'Agence des Nouvelles Interventions Sociales et de Santé</investigator_affiliation>
    <investigator_full_name>Thomas Saias</investigator_full_name>
    <investigator_title>Professeur</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03007277
org study id: PANJO
nct id: NCT03007277
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
In translation
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Parental self-efficacy
time frame: Child 6th month
description: 20-item questionnaire parental evaluating parental self efficacy and coercitive behaviors
measure: Parental Stress Inventory
time frame: Child 6th month
description: Subscale "parent-child interactions"
measure: Service Use
time frame: Child 6th month
description: Use of all social and health services by families
measure: Accidents
time frame: Child 6th month
description: Nb of accidents and accidents leading to hospitalization in children
measure: Child Maltreatment
time frame: Child 6th month
description: Number of services required within the child protection services
measure: Pacotis-Parental Impact
time frame: Child 6th and 12th month
description: Subscale of parental impact self-reported
measure: Parental Stress Inventory - Parental Distress
time frame: Child 6th and 12th month
description: Measure of Parental Distress
measure: Knowledge of Infant Development Inventory (KIDI questionnaire)
time frame: Child 6th and 12th month
description: Measure of Knowledge of Infant Development
measure: Edinburgh Postnatal Depression Scale
time frame: Child 6th and 12th month
description: Measure of depression in mothers
arm group label: PANJO Intervention
arm group type: Experimental
description: 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.
arm group label: Service as usual
arm group type: Active Comparator
description: 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.
intervention type: Other
intervention name: PANJO
description: 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.
arm group label: PANJO Intervention
arm group label: Service as usual
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas Saïas, Ph.D.
role: Principal Investigator
affiliation: L'Agence des Nouvelles Interventions Sociales et de Santé
facility: 
country: France
citation: 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.
responsible party type: Principal Investigator
investigator affiliation: L'Agence des Nouvelles Interventions Sociales et de Santé
investigator full name: Thomas Saias
investigator title: Professeur
sharing ipd: No