Supportive Program for Mother With BPD

NCT ID: NCT02203708

Last Updated: 2014-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-07-31

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)).

Detailed Description

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Conditions

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Parent-child Problem Borderline Personality Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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BPD prevention

Supportive Program for Mother with BPD (SuPMother-B) : BPD mothers participate to prevention program in groups or/and house calls.

Group Type ACTIVE_COMPARATOR

Supportive Program for Mother with BPD (SuPMother-B).

Intervention Type OTHER

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.

Usual care of BPD mothers

BPD mothers don't participate to Supportive Program (SuPMother-B).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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CHEYNIER

Role: PRINCIPAL_INVESTIGATOR

UTAMS PMI Empalot

LATOUR

Role: PRINCIPAL_INVESTIGATOR

UTAMS PMI Reynerie

BLEY-RIBET

Role: PRINCIPAL_INVESTIGATOR

UTAMS PMI Bonnefoy

MULQUIN

Role: PRINCIPAL_INVESTIGATOR

UTAMS PMI Rangueil

KOUBAA

Role: PRINCIPAL_INVESTIGATOR

UTAMS PMI Cazères

BERTIN

Role: PRINCIPAL_INVESTIGATOR

UTAMS PMI Montauban

Locations

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Service de psychiatrie de l'enfant et de l'adolescent - Hôpital La Grave - centre Hospitalier de Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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Interregional PHRC 2011

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

11 199 08

Identifier Type: -

Identifier Source: org_study_id

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