NCT02203708|Completed
Supportive Program for Mother With BPD
PAM-B
Effect on Relationship of a Brief Preventive Program: Pragmatic Pilot Randomized Controlled Trial." - Supportive Program for Mother With BPD
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PAM-B
Effect on Relationship of a Brief Preventive Program: Pragmatic Pilot Randomized Controlled Trial." - Supportive Program for Mother With BPD
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · French Ministry of Health
interventional
10
1 country
1
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2014
Actual (reported)Study Completion
July 2014
Actual (reported)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)).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
January 22, 2013
Actual (reported)May 2014
Actual (reported)July 2014
Actual (reported)July 30, 2014
Actual (reported)Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).
Visit 3 at 6 months
Brunet-Lezine Scale
Visit 2 (inclusion), 3 (6 months) and 4 (1 year)
Borderline Personality Disorder Severity Index (BPDSI)
Visit 2 (inclusion), 3 (6 months) and 4 (1 year)
Global Assessment Scale
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
Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
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).
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Service de psychiatrie de l'enfant et de l'adolescent - Hôpital La Grave - centre Hospitalier de Toulouse
Toulouse, 31059, France
CHEYNIER
UTAMS PMI Empalot
LATOUR
UTAMS PMI Reynerie
BLEY-RIBET
UTAMS PMI Bonnefoy
MULQUIN
UTAMS PMI Rangueil
10 participants (actual enrollment reported by the registry).
First Submitted
January 22, 2013
First Posted
July 30, 2014
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
KOUBAA
UTAMS PMI Cazères
BERTIN
UTAMS PMI Montauban
Primary Completion
May 2014
Actual (reported)Study Completion
July 2014
Actual (reported)Last Updated
July 30, 2014
Record last verified: 2014-07
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Source: ClinicalTrials.gov.
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