Supportive Program for Mother With BPD

Borderline Personality Disorder Clinical Trial

— PAM-B  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02203708
• Other study ID #: 11 199 08
• Secondary ID: Interregional PH
• Status: Completed
• Phase: N/A
• First received: January 22, 2013
• Last updated: July 28, 2014
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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)).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Parent-child Problem
• Personality Disorders

Intervention

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.

Locations

Country	Name	City	State
France	Service de psychiatrie de l'enfant et de l'adolescent - Hôpital La Grave - centre Hospitalier de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).		Visit 3 at 6 months	No
Secondary	Brunet-Lezine Scale	This scale permits to assess the psychomotor development of the child.	Visit 2 (inclusion), 3 (6 months) and 4 (1 year)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	social and demographic data	marital status, profession, socio-economic level, number of children	Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)	No
Secondary	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)	No