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临床试验/NCT04169048
NCT04169048Unknown不适用

Preventing Maltreatment and Promoting Mental Health in Children of Mothers With Borderline Personality Disorder - ProChild

Freie Universität Berlin1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2020年2月4日最近更新:
适应症

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

入选标准

  • 未提供

排除标准

  • 未提供

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Babette Renneberg

Professor of Clinical Psychology

Freie Universität Berlin

研究点 (1)

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