Supportive Program for Mother With BPD

NCT02203708 | Completed

• 2 other identifiers: 11 199 08Interregional PHRC 2011
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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)).

Conditions

Parent-child Problem; Borderline Personality Disorder

Keywords

BPD (Borderline Personality Disorder); Mother/child

Outcome Measures

Primary Outcomes (1)

• Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).

  Visit 3 at 6 months

Secondary Outcomes (8)

• 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)

Study Arms (2)

BPD prevention

ACTIVE COMPARATOR

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

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

Usual care of BPD mothers

NO INTERVENTION

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

Interventions

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

BPD prevention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

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

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• CHEYNIER

  UTAMS PMI Empalot

  PRINCIPAL INVESTIGATOR

• LATOUR

  UTAMS PMI Reynerie

  PRINCIPAL INVESTIGATOR

• BLEY-RIBET

  UTAMS PMI Bonnefoy

  PRINCIPAL INVESTIGATOR

• MULQUIN

  UTAMS PMI Rangueil

  PRINCIPAL INVESTIGATOR

• KOUBAA

  UTAMS PMI Cazères

  PRINCIPAL INVESTIGATOR

• BERTIN

  UTAMS PMI Montauban

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: July 30, 2014
• Study Start: July 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 30, 2014

Record last verified: 2014-07

Locations

FR (1)