多中心 RCT 研究方案，针对边缘型人格障碍母亲进行基于小组的养育干预，与等待对照组进行比较（ProChild*-SP1）。
Study protocol for a multi-center RCT testing a group-based parenting intervention tailored to mothers with borderline personality disorder against a waiting control group (ProChild*-SP1).
机构信息
Department of Education and Psychology, Freie Universität Berlin, Berlin, Germany.
Department of Psychology, Universität Bremen, Bremen, Germany.
出版信息
Trials. 2022 Jul 23;23(1):589. doi: 10.1186/s13063-022-06531-2.
BACKGROUND/AIMS: Borderline personality disorder (BPD) is a severe mental disorder characterized by an unstable sense of self, intense and rapidly changing affect, as well as impulsive and self-destructive behaviors. Interpersonal relationships of individuals with BPD are characterized by marked instability, a lack of dependability, and quick changes between love and hate. For children of individuals with BPD, this can lead to permanent stress and attachment insecurity and an increased risk of adverse physical and mental health development. To reduce dysfunctional parenting and improve positive parenting, and in turn, to promote healthy child development, a group intervention for mothers with BPD was developed. This study aims to evaluate this first disorder-specific parenting intervention for BPD in a randomized controlled trial.
METHOD
In a parallel-group, two-arm, randomized controlled trial, an initial N = 178 mothers diagnosed with BPD and their children aged 6 months to 6 years are assigned to either the parenting intervention or a waiting control group. If taking place, participants of both groups continue their regular treatment for BPD diagnosis (e.g., individual therapy, medication). The primary outcomes are changes in parenting from baseline (day 0) to post intervention (week 12) and follow-up (6 months after group intervention; month 9). The waiting control group can attend the group intervention at the end of all assessments. Participants allocated to the intervention group are expected to show improvement in their parenting and a reduction in child abuse potential. Maternal emotion regulation and mental distress are analyzed as secondary outcomes.
DISCUSSION
Mothers with BPD may need tailored help when reporting difficulties raising their children. The first disorder-specific parenting intervention has been developed to close this gap. ProChild is part of a large government-supported consortium, which aims to investigate different aspects of abuse and maltreatment in childhood and adolescence.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04169048 . Registered on Nov 19, 2019.
背景/目的：边缘型人格障碍（BPD）是一种严重的精神障碍，其特征为自我意识不稳定、强烈且迅速变化的情绪，以及冲动和自我毁灭行为。BPD 患者的人际关系以显著不稳定、缺乏可靠性以及爱与恨之间的快速变化为特征。对于 BPD 患者的子女来说，这可能导致永久性压力和依恋不安全感，并增加身心健康不良发展的风险。为了减少功能失调的养育方式并改善积极的养育方式，从而促进儿童健康发展，为 BPD 患者的母亲开发了一种团体干预措施。本研究旨在通过随机对照试验评估这种针对 BPD 的首个特定于障碍的养育干预措施。
方法
在一项平行组、双臂、随机对照试验中，将最初被诊断患有 BPD 的 178 名母亲及其年龄在 6 个月至 6 岁的子女随机分配到养育干预组或等待对照组。如果有发生，两组的参与者都将继续接受他们的 BPD 诊断常规治疗（例如，个体治疗、药物治疗）。主要结局是从基线（第 0 天）到干预后（第 12 周）和随访（组干预后 6 个月；第 9 个月）期间的养育方式变化。等待对照组可以在所有评估结束后参加团体干预。预计干预组的参与者将在养育方面有所改善，并减少虐待儿童的可能性。母亲的情绪调节和精神困扰作为次要结局进行分析。
讨论
报告在养育子女方面有困难的 BPD 母亲可能需要有针对性的帮助。第一个特定于障碍的养育干预措施旨在弥补这一差距。ProChild 是一个大型政府支持的联盟的一部分，该联盟旨在研究儿童和青少年时期虐待和虐待的不同方面。
试验注册
ClinicalTrials.gov NCT04169048。于 2019 年 11 月 19 日注册。
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