COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Supportive Program for Mother With BPD (PAM-B)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02203708
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : July 30, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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)).


Condition or disease Intervention/treatment Phase
Parent-child Problem Borderline Personality Disorder Other: Supportive Program for Mother with BPD (SuPMother-B). Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect on Relationship of a Brief Preventive Program: Pragmatic Pilot Randomized Controlled Trial." - Supportive Program for Mother With BPD
Study Start Date : July 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: BPD prevention
Supportive Program for Mother with BPD (SuPMother-B) : BPD mothers participate to prevention program in groups or/and house calls.
 Other: Supportive Program for Mother with BPD (SuPMother-B).

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.
No Intervention: Usual care of BPD mothers
BPD mothers don't participate to Supportive Program (SuPMother-B).


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Brunet-Lezine Scale [ Time Frame: Visit 2 (inclusion), 3 (6 months) and 4 (1 year) ]
    This scale permits to assess the psychomotor development of the child.

  2. Borderline Personality Disorder Severity Index (BPDSI) [ Time Frame: Visit 2 (inclusion), 3 (6 months) and 4 (1 year) ]
    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).

  3. Global Assessment Scale [ Time Frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 Year) ]
    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.

  4. 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) ]
  5. M.I.N.I. 5.0.0 French version [ Time Frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year) ]
    Structured interview to assess 17 disorders such as actual or passed depression, mania, abuse...

  6. Parenting Sense of Competence Scale (P.S.O.C) [ Time Frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year) ]
    This scale assess the perceived competence of the parent's role as educator.

  7. social and demographic data [ Time Frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year) ]
    marital status, profession, socio-economic level, number of children

  8. Data on care pathways [ Time Frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year) ]
    Questionnaire established by the research team to evaluate the use of care services by the mothers and children.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Mother:

  • Women with children and at least one child aged 2 months to 2 years, Borderline Personality Disorder with SIDP (Structured Interview for DSM Personality Disorders)
  • age above 18 years
  • written consent

Child:

  • ages between 2 months and 2 years,
  • parental consent for research participation.

Exclusion Criteria:

Mother:

  • chronic psychotic disorder, major depressive disorder, current mania or hypomania,
  • legal protection,
  • if no child can be included, the mother cannot be included.

Child :

•major psychomotor development disorder or psychiatric disorder according to the investigator.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203708


Locations
Layout table for location information
France
Service de psychiatrie de l'enfant et de l'adolescent - Hôpital La Grave - centre Hospitalier de Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Layout table for investigator information
Principal Investigator: CHEYNIER UTAMS PMI Empalot
Principal Investigator: LATOUR UTAMS PMI Reynerie
Principal Investigator: BLEY-RIBET UTAMS PMI Bonnefoy
Principal Investigator: MULQUIN UTAMS PMI Rangueil
Principal Investigator: KOUBAA UTAMS PMI Cazères
Principal Investigator: BERTIN UTAMS PMI Montauban
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02203708    
Other Study ID Numbers: 11 199 08
Interregional PHRC 2011 ( Other Grant/Funding Number: French Ministry of Health )
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: July 2014
Keywords provided by University Hospital, Toulouse:
BPD (Borderline Personality Disorder)
Mother/child
Additional relevant MeSH terms:
Layout table for MeSH terms
Personality Disorders
Borderline Personality Disorder
Mental Disorders