Supportive Program for Mother With BPD (PAM-B)
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|ClinicalTrials.gov Identifier: NCT02203708|
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : July 30, 2014
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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).
- 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 ]
- 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.
- 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).
- 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.
- 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) ]
- 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...
- 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.
- 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
- 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.
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
|Service de psychiatrie de l'enfant et de l'adolescent - Hôpital La Grave - centre Hospitalier de Toulouse|
|Toulouse, France, 31059|
|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|