Supportive Program for Mother With BPD (PAM-B)
Primary Purpose
Parent-child Problem, Borderline Personality Disorder
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Supportive Program for Mother with BPD (SuPMother-B).
Sponsored by
About this trial
This is an interventional prevention trial for Parent-child Problem focused on measuring BPD (Borderline Personality Disorder), Mother/child
Eligibility 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.
Sites / Locations
- Service de psychiatrie de l'enfant et de l'adolescent - Hôpital La Grave - centre Hospitalier de Toulouse
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
BPD prevention
Usual care of BPD mothers
Arm Description
Supportive Program for Mother with BPD (SuPMother-B) : BPD mothers participate to prevention program in groups or/and house calls.
BPD mothers don't participate to Supportive Program (SuPMother-B).
Outcomes
Primary Outcome Measures
Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).
Secondary Outcome Measures
Brunet-Lezine Scale
This scale permits to assess the psychomotor development of the child.
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).
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.
Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).
M.I.N.I. 5.0.0 French version
Structured interview to assess 17 disorders such as actual or passed depression, mania, abuse...
Parenting Sense of Competence Scale (P.S.O.C)
This scale assess the perceived competence of the parent's role as educator.
social and demographic data
marital status, profession, socio-economic level, number of children
Data on care pathways
Questionnaire established by the research team to evaluate the use of care services by the mothers and children.
Full Information
NCT ID
NCT02203708
First Posted
January 22, 2013
Last Updated
July 28, 2014
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT02203708
Brief Title
Supportive Program for Mother With BPD
Acronym
PAM-B
Official Title
Effect on Relationship of a Brief Preventive Program: Pragmatic Pilot Randomized Controlled Trial." - Supportive Program for Mother With BPD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parent-child Problem, Borderline Personality Disorder
Keywords
BPD (Borderline Personality Disorder), Mother/child
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BPD prevention
Arm Type
Active Comparator
Arm Description
Supportive Program for Mother with BPD (SuPMother-B) : BPD mothers participate to prevention program in groups or/and house calls.
Arm Title
Usual care of BPD mothers
Arm Type
No Intervention
Arm Description
BPD mothers don't participate to Supportive Program (SuPMother-B).
Intervention Type
Other
Intervention Name(s)
Supportive Program for Mother with BPD (SuPMother-B).
Intervention 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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Brunet-Lezine Scale
Description
This scale permits to assess the psychomotor development of the child.
Time Frame
Visit 2 (inclusion), 3 (6 months) and 4 (1 year)
Title
Borderline Personality Disorder Severity Index (BPDSI)
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).
Time Frame
Visit 2 (inclusion), 3 (6 months) and 4 (1 year)
Title
Global Assessment Scale
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.
Time Frame
Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 Year)
Title
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)
Title
M.I.N.I. 5.0.0 French version
Description
Structured interview to assess 17 disorders such as actual or passed depression, mania, abuse...
Time Frame
Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
Title
Parenting Sense of Competence Scale (P.S.O.C)
Description
This scale assess the perceived competence of the parent's role as educator.
Time Frame
Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
Title
social and demographic data
Description
marital status, profession, socio-economic level, number of children
Time Frame
Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
Title
Data on care pathways
Description
Questionnaire established by the research team to evaluate the use of care services by the mothers and children.
Time Frame
Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CHEYNIER
Organizational Affiliation
UTAMS PMI Empalot
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
LATOUR
Organizational Affiliation
UTAMS PMI Reynerie
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BLEY-RIBET
Organizational Affiliation
UTAMS PMI Bonnefoy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MULQUIN
Organizational Affiliation
UTAMS PMI Rangueil
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
KOUBAA
Organizational Affiliation
UTAMS PMI Cazères
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BERTIN
Organizational Affiliation
UTAMS PMI Montauban
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de psychiatrie de l'enfant et de l'adolescent - Hôpital La Grave - centre Hospitalier de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
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Supportive Program for Mother With BPD
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