Supportive Program for Mother With BPD

Study Overview
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Brief Summary
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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)).

Official Title
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Effect on Relationship of a Brief Preventive Program: Pragmatic Pilot Randomized Controlled Trial. - Supportive Program for Mother With BPD

Conditions
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Parent-child Problem, Borderline Personality Disorder

Intervention / Treatment
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* Other: Supportive Program for Mother with BPD (SuPMother-B).


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BPD prevention<br>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).<br>* 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.<br>|
| No Intervention: Usual care of BPD mothers<br>BPD mothers don't participate to Supportive Program (SuPMother-B). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)). |  | Visit 3 at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brunet-Lezine Scale | This scale permits to assess the psychomotor development of the child. | Visit 2 (inclusion), 3 (6 months) and 4 (1 year) | 
| Borderline Personality Disorder Severity Index (BPDSI) | 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). | Visit 2 (inclusion), 3 (6 months) and 4 (1 year) | 
| Global Assessment Scale | 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. | Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 Year) | 
| Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)). |  | Visit 2 (inclusion) and visit 4 (1 Year) | 
| M.I.N.I. 5.0.0 French version | Structured interview to assess 17 disorders such as actual or passed depression, mania, abuse... | Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year) | 
| Parenting Sense of Competence Scale (P.S.O.C) | This scale assess the perceived competence of the parent's role as educator. | Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year) | 
| social and demographic data | marital status, profession, socio-economic level, number of children | Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year) | 
| Data on care pathways | Questionnaire established by the research team to evaluate the use of care services by the mothers and children. | Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPD (Borderline Personality Disorder), Mother/child