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Completed

NCT Number: NCT02203708

Supportive Program for Mother With BPD

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)).

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Key information

Conditions

Parent-child Problem Borderline Personality Disorder Mental Disorders Personality Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Visit 3 at 6 months

Secondary outcomes

  1. Brunet-Lezine Scale

    Time frame: Visit 2 (inclusion), 3 (6 months) and 4 (1 year)

    This scale permits to assess the psychomotor development of the child.

  2. Borderline Personality Disorder Severity Index (BPDSI)

    Time frame: Visit 2 (inclusion), 3 (6 months) and 4 (1 year)

    Borderline Personality Disorder Severity Index (BPDSI) is a semi-structured interview assessing the frequency and severity of manifestations of borderline personality disorders of the mother during an agreed period (3 months to 1 year).

  3. Global Assessment Scale

    Time frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 Year)

    This scale corresponds to the 5th axis of the Diagnostic and Statistical Manual of Mental Disorders (DSM) and permits to assess the overall functioning of the mother.

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

    Time frame: Visit 2 (inclusion) and visit 4 (1 Year)

  5. M.I.N.I. 5.0.0 French version

    Time frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)

    Structured interview to assess 17 disorders such as actual or passed depression, mania, abuse...

  6. Parenting Sense of Competence Scale (P.S.O.C)

    Time frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)

    This scale assess the perceived competence of the parent's role as educator.

  7. social and demographic data

    Time frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)

    marital status, profession, socio-economic level, number of children

  8. Data on care pathways

    Time frame: Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year)

    Questionnaire established by the research team to evaluate the use of care services by the mothers and children.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Effect on Relationship of a Brief Preventive Program: Pragmatic Pilot Randomized Controlled Trial." - Supportive Program for Mother With BPD

Acronym: PAM-B

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2014
Registry last updated
Jul 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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