Preventing Maltreatment and Promoting Mental Health in Children of Mothers With Borderline Personality Disorder - ProChild
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change in dysfunctional discipline practices
研究概览
简要总结
The first disorder-specific parenting training program for mothers with Borderline Personality Disorder (M-BPD) is evaluated in a randomized controlled trial.
The training program is expected to have positive effects on parenting behavior, decrease the risk of maltreatment of the child, and improve emotion regulation in mothers at post treatment and at 6-month follow-up compared to a control group (treatment as usual; TAU).
Additionally, disorder-specific aspects of dysfunctional parenting behavior as well as BPD-specific aspects of child maltreatment are compared to a clinical control group (mothers with anxiety and/or depression, M-AD/D) and a healthy control group (M-CON).
To assess the differential development of parenting, the risk of maltreatment and emotion dysregulation in untreated M-BPD are compared to M-CON. The investigators expect the difference to increase over time, indicating a worsening in BPD parenting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •for mothers with BPD:
- •diagnosed with BPD (assessed via SCID-PD)
- •running or completed therapy for BPD symptoms
- •child between 6 months and 6 years
- •living with child or regular (weekly) contact
排除标准
- •for the mothers with BPD
- •Acute child endangerment
- •maternal acute suicidality
- •maternal psychotic symptoms (assessed via SCID-CV)
- •maternal acute alcohol or drug dependency (assessed via SCID-CV)
- •maternal diagnosed intellectual disability.
- •Inclusion criteria for mothers with depression and/or anxiety disorders:
- •diagnosed with acute affective or anxiety disorder (assessed via SCID-CV)
- •child between 6 months and 6 years
- •living with child or regular (weekly) contact
- •Exclusion criteria for mothers with depression and/or anxiety disorders:
- •Acute child endangerment
- •maternal acute suicidality
- •maternal psychotic symptoms (assessed via SCID-CV)
- •maternal acute alcohol or drug dependency (assessed via SCID-CV)
- •maternal diagnosed intellectual disability
- •lifetime diagnosis of BPD (assessed via SCID-PD)
- •Inclusion criteria for healthy control group:
- •child between 6 months and 6 years
- •living with child or regular (weekly) contact
- •Exclusion criteria for the healthy control group:
- •Acute child endangerment
- •maternal acute suicidality
- •maternal psychotic symptoms (assessed via SCID-CV)
- •maternal acute alcohol or drug dependency (assessed via SCID-CV)
- •maternal diagnosed intellectual disability.
- •lifetime diagnosis of BPD (assessed via SCID-PD)
- •any acute mental disorder (assessed via SCID-CV)
- •current psychotherapy
研究组 & 干预措施
Intervention group (BPD)
Participants (N=60) receive the weekly conducted intervention (group training for mothers with BPD) over the period of 12 weeks (12 sessions). Assessments of each participant: T0 (pre-intervention), T1 (post-intervention) and follow-up (6 months after T1).
干预措施: Group training for mothers with Borderline Personality Disorder (Behavioral)
waiting control group (BPD)
Members of this group (N=60) receive no intervention but treatment as usual (TAU). After completing all assessment points (T0, T1, T2), they can receive the intervention of the intervention group (group training).
clinical control group (AD/MDD)
Mothers with anxiety and/or depression (N=60) receive no intervention. Assessment point only T0.
healthy control group
Mothers with no actual mental disorder (N=60) receive no intervention.# Assessment points T0, T1, T2.
结局指标
主要结局
Change in dysfunctional discipline practices
时间窗: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Parenting Scale (Arnold, O'Leary, Wolff \& Acker, 1993; german version: Erziehungsfragebogen-Kurzform, EFB-K; Miller, 2001). Questionniare measuring dysfunctional discipline practices in parents. Mean values range between 1-7 with higher values indicating more negative parenting strategies.
Change in physical and psychological aggression towards child
时间窗: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Conflict Tactic Scale - Parent Child (CTS-PC; Strauss, 1998). The CTSPC measures the extent to which a parent has carried out specific acts of physical and psychological aggression. Range 0-300 with higher values indicating higher annual frequency
Change in positive and dysfunctional parenting strategies
时间窗: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Alabama Parenting Questionnaire (Frick, 1991; German DEAPQ-EL-GS; Reichle \& Franiek, 2007). The questionnaire assesses several parenting strategies with 7 subscales (positive parenting, responsible parenting, parental Involvement, poor monitoring/supervision, inconsistent discipline, corporal punishment, powerful implementation). Range 6-30, with higher values indicating more of the respective parenting strategy
Change in child rearing competence
时间窗: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Parenting Sense of Competence Scale (PSOC, Gibeau- Wallston \& Wandersman, 1978; German FKE; Miller, 2001). The PSOC measures how parents perceive their child rearing competence. Range 0-96 with higher values indicating higher sense of competence.
Change in parental stress
时间窗: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Parental Stress Index (PSI, Abidin, 1995; German EBI; Tröster, 2010). The PSI is a dimensional rating of parental stress. Range 48 - 240 with higher values indicating higher stress.
Change in physical abuse potential
时间窗: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment)
Child Abuse Potential Inventory (CAPI, Milner, 1986, German EBSK; Deegener et al., 2009). The CAPI measures physical abuse potential with reference to the individual burden and three validity scales: a lie scale, a random response scale, and an inconsistency scale. t-values are calculated considering all scales.
Change in child neglect
时间窗: day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment) and for the intervention group after each session.
Child Neglect Index (CNI; Trocmé, 1996). The CNI measures child neglect, rated by the diagnostician. Range 0-80 with higher values indicating higher neglect.
次要结局
- Change in emotion regulation(day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment))
- Change in borderline specific thoughts and feelings(day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment))
- Change in mental distress(day 0 (before treatment), week 12 (after treatment), month 9 (6 months after second assessment))
研究者
Babette Renneberg
Professor of Clinical Psychology
Freie Universität Berlin