Effect on Relationship of a Brief Preventive Program: Pragmatic Pilot Randomized Controlled Trial." - Supportive Program for Mother With BPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).
研究概览
简要总结
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)).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •ages between 2 months and 2 years,
- •parental consent for research participation.
排除标准
- •chronic psychotic disorder, major depressive disorder, current mania or hypomania,
- •legal protection,
- •if no child can be included, the mother cannot be included.
- •major psychomotor development disorder or psychiatric disorder according to the investigator.
研究组 & 干预措施
BPD prevention
Supportive Program for Mother with BPD (SuPMother-B) : BPD mothers participate to prevention program in groups or/and house calls.
干预措施: Supportive Program for Mother with BPD (SuPMother-B). (Other)
Usual care of BPD mothers
BPD mothers don't participate to Supportive Program (SuPMother-B).
结局指标
主要结局
Difference between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).
时间窗: Visit 3 at 6 months
次要结局
- 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))
- Parenting Sense of Competence Scale (P.S.O.C)(Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year))
- social and demographic data(Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year))
- Data on care pathways(Visit 2 (inclusion), Visit 3 (6 months), Visit 4 (1 year))