Viewing Study NCT02203708



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Last Modification Date: 2024-10-26 @ 11:28 AM
Study NCT ID: NCT02203708
Status: COMPLETED
Last Update Posted: 2014-07-30
First Post: 2013-01-22

Brief Title: Supportive Program for Mother With BPD
Sponsor: University Hospital Toulouse
Organization: University Hospital Toulouse

Study Overview

Official Title: Effect on Relationship of a Brief Preventive Program Pragmatic Pilot Randomized Controlled Trial - Supportive Program for Mother With BPD
Status: COMPLETED
Status Verified Date: 2014-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PAM-B
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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
Interregional PHRC 2011 OTHER_GRANT French Ministry of Health None