<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/NCT03300713</url>
  </required_header>
  <id_info>
    <org_study_id>2015_04</org_study_id>
    <secondary_id>2016-A00540-51</secondary_id>
    <nct_id>NCT03300713</nct_id>
  </id_info>
  <brief_title>MOther-Child Interaction Assessment TRAINING for Pediatricians</brief_title>
  <acronym>MOCITRAINING</acronym>
  <official_title>MOther-Child Interaction Assessment TRAINING for Pediatricians</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The originality of the MOCITRAINING study lies in the integration of infant and maternal care&#xD;
      during the pediatric consultation and the assessment of the impact of this type of care in&#xD;
      the short and medium term on The MOCITRAINING program could contribute to improving the&#xD;
      quality of parent-child interactions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 2, 2017</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of pathological Alarm Distress BaBy (ADBB) scores</measure>
    <time_frame>in 12-month-aged children.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of pathological Alarm Distress BaBy (ADBB) scores</measure>
    <time_frame>in 4, 9 and 24 month-aged children</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of digestive disorders</measure>
    <time_frame>in 4, 9, 12 and 24 month-aged children</time_frame>
    <description>presence/absence of infantile regurgitations and colics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of daytime sleep hours</measure>
    <time_frame>in 4, 9, 12 and 24 month-aged children</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of nighttime awakenings</measure>
    <time_frame>in 4, 9, 12 and 24 month-aged children</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores on maternal self-evaluation scales (Likert scales)</measure>
    <time_frame>at 12 and 24 months postpartum</time_frame>
    <description>Scores on maternal self-evaluation scales (Likert scales) about parent-child relations (Items concerning comfort and pleasure during interactions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of dyads referred for psychiatric or perinatal psychiatric consultations</measure>
    <time_frame>in 4, 9, 12 and 24 month-aged children</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of maternal psychotropic medication</measure>
    <time_frame>in 4, 9, 12 and 24 month-aged children</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">3504</enrollment>
  <condition>Child Behavior Disorders</condition>
  <condition>Mother-child Relations</condition>
  <condition>Depression, Postpartum</condition>
  <arm_group>
    <arm_group_label>F+ group (Mocitraining program)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>including 8 pediatricians' clusters. F+ pediatricians will attend a specific training focused on mother-child interactions, maternal psychiatric disorders, particularly PND screening and early interventions for non-psychiatric physician.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>F- group (usual follow-up)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>grouping 8 pediatricians' clusters. They will not receive the initial training on early interactional disorders and PND screening</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MOCITRAINING program</intervention_name>
    <description>The program is clinical and psychometric tools for screening for interactions and postpartum psychiatric disorders. The program will expose the existing care arrangements and the different possible orientations of the families according to the identified problem.</description>
    <arm_group_label>F+ group (Mocitraining program)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>usual follow-up</intervention_name>
    <description>usual follow-up</description>
    <arm_group_label>F- group (usual follow-up)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Each child will be included WITH his biological mother at the first-month visit after&#xD;
             birth.&#xD;
&#xD;
          -  Age: 1 month + / - 15 days (child), accompanied by his biological mother&#xD;
&#xD;
          -  Mother able to read French;&#xD;
&#xD;
          -  Signed consent letter after complete information of parents about the MOCITRAINING&#xD;
             study, its principle, advantages and disadvantages.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preterm babies.&#xD;
&#xD;
          -  Children from a twin or multiple pregnancy.&#xD;
&#xD;
          -  Children with somatic diagnosis explaining the presence of digestive, sleeping or&#xD;
             interactional disorders.&#xD;
&#xD;
          -  Refusal to participate after clear information about the study;&#xD;
&#xD;
          -  Refusal to sign the consent letter;&#xD;
&#xD;
          -  Refusal to be informed of a diagnostic hypothesis;&#xD;
&#xD;
          -  Participants not covered by the Social Security system;&#xD;
&#xD;
          -  Participants incapable of consenting or under legal protection (guardianship or&#xD;
             curatorship).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>23 Days</minimum_age>
    <maximum_age>37 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Renaud Jardri, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Renaud Jardri, MD,PhD</last_name>
    <phone>(0) 320 446 747</phone>
    <phone_ext>+33</phone_ext>
    <email>renaud.jardri@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Renaud Jardri, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>September 30, 2022</last_update_submitted>
  <last_update_submitted_qc>September 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mass screening</keyword>
  <keyword>Pediatrician training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression, Postpartum</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Child Behavior Disorders</mesh_term>
  </condition_browse>
  <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/NCT03300713
org study id: 2015_04
secondary id: 2016-A00540-51
nct id: NCT03300713
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The originality of the MOCITRAINING study lies in the integration of infant and maternal care
      during the pediatric consultation and the assessment of the impact of this type of care in
      the short and medium term on The MOCITRAINING program could contribute to improving the
      quality of parent-child interactions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Frequency of pathological Alarm Distress BaBy (ADBB) scores
time frame: in 12-month-aged children.
measure: Frequency of pathological Alarm Distress BaBy (ADBB) scores
time frame: in 4, 9 and 24 month-aged children
measure: Frequency of digestive disorders
time frame: in 4, 9, 12 and 24 month-aged children
description: presence/absence of infantile regurgitations and colics
measure: Number of daytime sleep hours
time frame: in 4, 9, 12 and 24 month-aged children
measure: Number of nighttime awakenings
time frame: in 4, 9, 12 and 24 month-aged children
measure: Scores on maternal self-evaluation scales (Likert scales)
time frame: at 12 and 24 months postpartum
description: Scores on maternal self-evaluation scales (Likert scales) about parent-child relations (Items concerning comfort and pleasure during interactions)
measure: Frequency of dyads referred for psychiatric or perinatal psychiatric consultations
time frame: in 4, 9, 12 and 24 month-aged children
measure: Frequency of maternal psychotropic medication
time frame: in 4, 9, 12 and 24 month-aged children
arm group label: F+ group (Mocitraining program)
arm group type: Experimental
description: including 8 pediatricians' clusters. F+ pediatricians will attend a specific training focused on mother-child interactions, maternal psychiatric disorders, particularly PND screening and early interventions for non-psychiatric physician.
arm group label: F- group (usual follow-up)
arm group type: Sham Comparator
description: grouping 8 pediatricians' clusters. They will not receive the initial training on early interactional disorders and PND screening
intervention type: Other
intervention name: MOCITRAINING program
description: The program is clinical and psychometric tools for screening for interactions and postpartum psychiatric disorders. The program will expose the existing care arrangements and the different possible orientations of the families according to the identified problem.
arm group label: F+ group (Mocitraining program)
intervention type: Other
intervention name: usual follow-up
description: usual follow-up
arm group label: F- group (usual follow-up)
criteria: 
gender: All
minimum age: 23 Days
maximum age: 37 Days
healthy volunteers: No
last name: Renaud Jardri, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Renaud Jardri, MD,PhD
phone: (0) 320 446 747
phone ext: +33
email: renaud.jardri@chru-lille.fr
facility: 
status: Recruiting
investigator: 
country: France
responsible party type: Sponsor
mesh term: Depression, Postpartum
mesh term: Mental Disorders
mesh term: Child Behavior Disorders
sharing ipd: No