<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/NCT02203708</url>
  </required_header>
  <id_info>
    <org_study_id>11 199 08</org_study_id>
    <secondary_id>Interregional PHRC 2011</secondary_id>
    <nct_id>NCT02203708</nct_id>
  </id_info>
  <brief_title>Supportive Program for Mother With BPD</brief_title>
  <acronym>PAM-B</acronym>
  <official_title>Effect on Relationship of a Brief Preventive Program: Pragmatic Pilot Randomized Controlled Trial.&quot; - Supportive Program for Mother With BPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Borderline Personality Disorder (BPD) is characterized by a pervasive pattern of instability&#xD;
      of interpersonal relationships, self-image and emotions as well as marked impulsivity. When&#xD;
      patients have children, they are at high risk of severe emotional and relational disturbances&#xD;
      (withdrawal, low self-esteem, depression, suicidal thoughts). In addition, studies support&#xD;
      the effectiveness of parental guidance group to reduce emotional and behavioral difficulties&#xD;
      of children. To our knowledge there are no programs directed to mothers with BPD who received&#xD;
      a controlled evaluation.&#xD;
&#xD;
      From experience with parental guidance, data from the observation of children of patients&#xD;
      with BPD and psychosocial programs directed to patients BPD, we have built for preventive&#xD;
      intervention. The Supportive Program for Mothers with BPD (SuPMother-B) consists of 10 group&#xD;
      sessions providing information (education, childcare, care specific to BPD) and promotes&#xD;
      mother-child interactions (observation, games).&#xD;
&#xD;
      Purpose: Compare the effect of a program (SuPMother-B) group, of 10 sessions, offered to&#xD;
      mothers with a BPD in addition to a minimal intervention (diagnostic announcement and&#xD;
      provision of health care resources) on behavior withdrawal of children at 6 months compared&#xD;
      to a group of mothers receiving only minimal intervention.&#xD;
&#xD;
      Primary outcome: Difference at 6 months between the experimental and control groups on scores&#xD;
      on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).</measure>
    <time_frame>Visit 3 at 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brunet-Lezine Scale</measure>
    <time_frame>Visit 2 (inclusion), 3 (6 months) and 4 (1 year)</time_frame>
    <description>This scale permits to assess the psychomotor development of the child.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Borderline Personality Disorder Severity Index (BPDSI)</measure>
    <time_frame>Visit 2 (inclusion), 3 (6 months) and 4 (1 year)</time_frame>
    <description>Borderline Personality Disorder Severity Index (BPDSI) is a semi-structured interview assessing the frequency and severity of manifestations of borderline personality disorders of the mother during an agreed period (3 months to 1 year).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Assessment Scale</measure>
    <time_frame>Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 Year)</time_frame>
    <description>This scale corresponds to the 5th axis of the Diagnostic and Statistical Manual of Mental Disorders (DSM) and permits to assess the overall functioning of the mother.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).</measure>
    <time_frame>Visit 2 (inclusion) and visit 4 (1 Year)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>M.I.N.I. 5.0.0 French version</measure>
    <time_frame>Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)</time_frame>
    <description>Structured interview to assess 17 disorders such as actual or passed depression, mania, abuse...</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting Sense of Competence Scale (P.S.O.C)</measure>
    <time_frame>Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)</time_frame>
    <description>This scale assess the perceived competence of the parent's role as educator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>social and demographic data</measure>
    <time_frame>Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)</time_frame>
    <description>marital status, profession, socio-economic level, number of children</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Data on care pathways</measure>
    <time_frame>Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)</time_frame>
    <description>Questionnaire established by the research team to evaluate the use of care services by the mothers and children.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Parent-child Problem</condition>
  <condition>Borderline Personality Disorder</condition>
  <arm_group>
    <arm_group_label>BPD prevention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Supportive Program for Mother with BPD (SuPMother-B) : BPD mothers participate to prevention program in groups or/and house calls.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care of BPD mothers</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>BPD mothers don't participate to Supportive Program (SuPMother-B).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supportive Program for Mother with BPD (SuPMother-B).</intervention_name>
    <description>The development of the program is based on several principles: group process, groupware, mentalization, parental values, behavioral strategies and information on the child's needs, knowledge of the BPD and the strategies of get better. The program will last 10 sessions of group of about 2h.&#xD;
Minimal intervention. All study participants receive an individual interview about 45 minutes with a psychiatrist for three objectives: information on the diagnosis of BPD, information on resources for health care and educational aids.</description>
    <arm_group_label>BPD prevention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Mother:&#xD;
&#xD;
          -  Women with children and at least one child aged 2 months to 2 years, Borderline&#xD;
             Personality Disorder with SIDP (Structured Interview for DSM Personality Disorders)&#xD;
&#xD;
          -  age above 18 years&#xD;
&#xD;
          -  written consent&#xD;
&#xD;
        Child:&#xD;
&#xD;
          -  ages between 2 months and 2 years,&#xD;
&#xD;
          -  parental consent for research participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Mother:&#xD;
&#xD;
          -  chronic psychotic disorder, major depressive disorder, current mania or hypomania,&#xD;
&#xD;
          -  legal protection,&#xD;
&#xD;
          -  if no child can be included, the mother cannot be included.&#xD;
&#xD;
        Child :&#xD;
&#xD;
        •major psychomotor development disorder or psychiatric disorder according to the&#xD;
        investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>CHEYNIER</last_name>
    <role>Principal Investigator</role>
    <affiliation>UTAMS PMI Empalot</affiliation>
  </overall_official>
  <overall_official>
    <last_name>LATOUR</last_name>
    <role>Principal Investigator</role>
    <affiliation>UTAMS PMI Reynerie</affiliation>
  </overall_official>
  <overall_official>
    <last_name>BLEY-RIBET</last_name>
    <role>Principal Investigator</role>
    <affiliation>UTAMS PMI Bonnefoy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>MULQUIN</last_name>
    <role>Principal Investigator</role>
    <affiliation>UTAMS PMI Rangueil</affiliation>
  </overall_official>
  <overall_official>
    <last_name>KOUBAA</last_name>
    <role>Principal Investigator</role>
    <affiliation>UTAMS PMI Cazères</affiliation>
  </overall_official>
  <overall_official>
    <last_name>BERTIN</last_name>
    <role>Principal Investigator</role>
    <affiliation>UTAMS PMI Montauban</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de psychiatrie de l'enfant et de l'adolescent - Hôpital La Grave - centre Hospitalier de Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>January 22, 2013</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>July 28, 2014</last_update_submitted>
  <last_update_submitted_qc>July 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BPD (Borderline Personality Disorder)</keyword>
  <keyword>Mother/child</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Personality Disorders</mesh_term>
    <mesh_term>Borderline Personality Disorder</mesh_term>
  </condition_browse>
  <!-- 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/NCT02203708
org study id: 11 199 08
secondary id: Interregional PHRC 2011
nct id: NCT02203708
lead sponsor: 
has dmc: No
Borderline Personality Disorder (BPD) is characterized by a pervasive pattern of instability
      of interpersonal relationships, self-image and emotions as well as marked impulsivity. When
      patients have children, they are at high risk of severe emotional and relational disturbances
      (withdrawal, low self-esteem, depression, suicidal thoughts). In addition, studies support
      the effectiveness of parental guidance group to reduce emotional and behavioral difficulties
      of children. To our knowledge there are no programs directed to mothers with BPD who received
      a controlled evaluation.

      From experience with parental guidance, data from the observation of children of patients
      with BPD and psychosocial programs directed to patients BPD, we have built for preventive
      intervention. The Supportive Program for Mothers with BPD (SuPMother-B) consists of 10 group
      sessions providing information (education, childcare, care specific to BPD) and promotes
      mother-child interactions (observation, games).

      Purpose: Compare the effect of a program (SuPMother-B) group, of 10 sessions, offered to
      mothers with a BPD in addition to a minimal intervention (diagnostic announcement and
      provision of health care resources) on behavior withdrawal of children at 6 months compared
      to a group of mothers receiving only minimal intervention.

      Primary outcome: Difference at 6 months between the experimental and control groups on scores
      on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).
time frame: Visit 3 at 6 months
measure: Brunet-Lezine Scale
time frame: Visit 2 (inclusion), 3 (6 months) and 4 (1 year)
description: This scale permits to assess the psychomotor development of the child.
measure: Borderline Personality Disorder Severity Index (BPDSI)
time frame: Visit 2 (inclusion), 3 (6 months) and 4 (1 year)
description: Borderline Personality Disorder Severity Index (BPDSI) is a semi-structured interview assessing the frequency and severity of manifestations of borderline personality disorders of the mother during an agreed period (3 months to 1 year).
measure: Global Assessment Scale
time frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 Year)
description: This scale corresponds to the 5th axis of the Diagnostic and Statistical Manual of Mental Disorders (DSM) and permits to assess the overall functioning of the mother.
measure: Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).
time frame: Visit 2 (inclusion) and visit 4 (1 Year)
measure: M.I.N.I. 5.0.0 French version
time frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
description: Structured interview to assess 17 disorders such as actual or passed depression, mania, abuse...
measure: Parenting Sense of Competence Scale (P.S.O.C)
time frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
description: This scale assess the perceived competence of the parent's role as educator.
measure: social and demographic data
time frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
description: marital status, profession, socio-economic level, number of children
measure: Data on care pathways
time frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
description: Questionnaire established by the research team to evaluate the use of care services by the mothers and children.
arm group label: BPD prevention
arm group type: Active Comparator
description: Supportive Program for Mother with BPD (SuPMother-B) : BPD mothers participate to prevention program in groups or/and house calls.
arm group label: Usual care of BPD mothers
arm group type: No Intervention
description: BPD mothers don't participate to Supportive Program (SuPMother-B).
intervention type: Other
intervention name: Supportive Program for Mother with BPD (SuPMother-B).
description: The development of the program is based on several principles: group process, groupware, mentalization, parental values, behavioral strategies and information on the child's needs, knowledge of the BPD and the strategies of get better. The program will last 10 sessions of group of about 2h.
Minimal intervention. All study participants receive an individual interview about 45 minutes with a psychiatrist for three objectives: information on the diagnosis of BPD, information on resources for health care and educational aids.
arm group label: BPD prevention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: CHEYNIER
role: Principal Investigator
affiliation: UTAMS PMI Empalot
last name: LATOUR
role: Principal Investigator
affiliation: UTAMS PMI Reynerie
last name: BLEY-RIBET
role: Principal Investigator
affiliation: UTAMS PMI Bonnefoy
last name: MULQUIN
role: Principal Investigator
affiliation: UTAMS PMI Rangueil
last name: KOUBAA
role: Principal Investigator
affiliation: UTAMS PMI Cazères
last name: BERTIN
role: Principal Investigator
affiliation: UTAMS PMI Montauban
facility: 
country: France
responsible party type: Sponsor
mesh term: Personality Disorders
mesh term: Borderline Personality Disorder