The Effectiveness and Change Mechanisms of Mentalization Based Therapy for Children (MBT-C)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 2
- 主要终点
- Change from Baseline to 36th week on the Child Behavior Checklist (CBCL)
研究概览
简要总结
The main aim of the project is to investigate the effectiveness and change mechanisms of Mentalization Based Therapy for Children (MBT-C; Midgley et al., 2017). MBT-C is a transdiagnostic treatment for children aged between 5 to 12 years old with the main aim of increasing mentalization and restoring epistemic trust. Parallel parental work takes place to increase parental mentalization. This project will test the effectiveness of MBT-C in a parallel group single blind pragmatic Randomized Controlled Trial (pRCT) conducted in Turkey in comparison to a parenting and social skills group. The sample will include 240 children between 5-12 years old with internalizing and externalizing and comorbid internalizing/externalizing problems and their parents. During the study, the patients will be randomized to two arms, and the treatment's effectiveness will be investigated both at short (8th and 12th weeks) and long terms (24th and 36th week) to also assess relapse prevention. Thelarge sample size and the longitudinal evaluation of primary (decrease in problems), and secondary outcomes will enable the investigation of mediators and moderators.
This project will also undertake a rigorous psychotherapy process study within the RCT, examining for the first time, for which children and under what circumstances MBT-C may be most effective, meaningfully linking process with outcome. For this purpose, patients' baseline characteristics, especially attachment security and mentalization deficits that may interact with treatment outcome (moderators) and different dimensions of mentalization that develop over the course of the treatment (change mechanisms/mediators) will be assessed.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Mentalization Based Treatment for Children (MBT-C)
Mentalization Based Therapy for Children (MBT-C) is a transdiagnostic time-limited (12 weekly sessions) and manualized treatment for children aged between 5 to 12 years old with the main aim of increasing mentalization and restoring epistemic trust. Parallel parental work takes place to increase parental mentalization.
干预措施: Mentalization-Based Treatment for Children (MBT-C) (Behavioral)
Parenting and Social Skills Group
Parenting groups will run for 12 weeks with 10 parents per group. They will involve activities to help parents develop effective parenting skills via working on a family genogram, providing information on child development, developing acceptance and empathy, setting boundaries and anger regulation.
The social skills groups will run for 12 weeks and will be conducted with 10 children per group. They will involve activities on self-presentation, peer communication, play skills, empathy and anger management.
干预措施: Parenting and Social Skills Group (Behavioral)
结局指标
主要结局
Change from Baseline to 36th week on the Child Behavior Checklist (CBCL)
时间窗: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
The Child Behavior Checklist (CBCL; Achenbach, 1991) is a widely used method of identifying problematic behaviors in children with two separate versions for ages 1.5-5 and 6-18. The CBCL asks the parents to indicate how true a series of 112 problem behavior items are for their child in the past two months on a 3-point likert scale (0 = "not true", 1= "sometimes true", and 2 = "very true or often true"). Outcomes can be determined for significant problems for Internalizing (e.g., depression, anxiety), Externalizing (e.g., aggression, violence) or Total Problems. The scale has been adapted to Turkish with good reliability and validity (Erol et al., 1995).
次要结局
- Change from Baseline to 36th week on the Me and My Feelings Questionnaire (M&MF)(Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4))
- Change from Baseline to 36th week on the Parental Stress Index - Short Form (PSI-SF)(Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4))
- Change from Baseline to 36th week on the Difficulties in Emotion Regulation Scale (DERS)(Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4))
- Change from Baseline to 36th week on the Emotion Regulation Checklist (ERC)(Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4))
- Change from Baseline to 12th week on the Children's Global Assessment Scale (CGAS)(Baseline (T0), 8th week (T1), 12th week (T2))
- Change from Baseline to 36th week on the Parent Reflective Functioning Questionnaire (PRF-Q)(Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4))
研究者
Sibel Halfon
Associate Professor
Istanbul Bilgi University