Clinical trial NCT02203708: Supportive Program for Mother With BPD
Official title: Effect on Relationship of a Brief Preventive Program: Pragmatic Pilot Randomized Controlled Trial." - Supportive Program for Mother With BPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent-child Problem
Borderline Personality Disorder
Keywords: BPD (Borderline Personality Disorder)
Mother/child
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)).


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.

Primary outcomes:
measure: Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).
timeFrame: Visit 3 at 6 months
Secondary outcomes:
measure: Brunet-Lezine Scale
timeFrame: Visit 2 (inclusion), 3 (6 months) and 4 (1 year)
measure: Borderline Personality Disorder Severity Index (BPDSI)
timeFrame: Visit 2 (inclusion), 3 (6 months) and 4 (1 year)
measure: Global Assessment Scale
timeFrame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 Year)
measure: Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).
timeFrame: Visit 2 (inclusion) and visit 4 (1 Year)
measure: M.I.N.I. 5.0.0 French version
timeFrame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
measure: Parenting Sense of Competence Scale (P.S.O.C)
timeFrame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
measure: social and demographic data
timeFrame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
measure: Data on care pathways
timeFrame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Service de psychiatrie de l'enfant et de l'adolescent - Hôpital La Grave - centre Hospitalier de Toulouse
Study officials:
affiliation: UTAMS PMI Empalot
name: CHEYNIER
role: PRINCIPAL_INVESTIGATOR
affiliation: UTAMS PMI Reynerie
name: LATOUR
role: PRINCIPAL_INVESTIGATOR
affiliation: UTAMS PMI Bonnefoy
name: BLEY-RIBET
role: PRINCIPAL_INVESTIGATOR
affiliation: UTAMS PMI Rangueil
name: MULQUIN
role: PRINCIPAL_INVESTIGATOR
affiliation: UTAMS PMI Cazères
name: KOUBAA
role: PRINCIPAL_INVESTIGATOR
affiliation: UTAMS PMI Montauban
name: BERTIN
role: PRINCIPAL_INVESTIGATOR
References: