A Pragmatic Randomized Controlled Trial of Regulation-Focused Psychotherapy (RFP-C) for Children With Externalizing Problems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Turgay DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) Disruptive Behavior Disorders Rating Scale (T-DSM-IV-S; Turgay, 1994)
研究概览
简要总结
Regulation Focused Psychotherapy for Children (RFP-C) is a manualized, time-limited psychodynamic treatment for children with externalizing symptoms. RFP-C also holds the potential to treat a wider range of psychopathology, including comorbid internalizing conditions, because it aims to improve emotion regulation which is a transdiagnostic component of childhood mental health. This study will replicate previous findings supporting the efficacy of RFP-C. It will test the effectiveness of RFP-C in parallel groups via a pragmatic Randomized Controlled Trial (RCT) conducted at Istanbul Bilgi University's outpatient clinic in Istanbul, Turkey with a sample of 80 children with externalizing and comorbid internalizing/externalizing problems in comparison to a parental awareness and child social skills group. Primary outcomes will be child externalizing problems and oppositional defiance problems. The treatment's effectiveness and change mechanisms will be investigated both at the end of treatment (primary endpoint) and at 6-month follow-up (secondary endpoint). The project results will provide preliminary answers about the active ingredients of RFP-C, help improve therapeutic interventions, and design optimal treatments for externalizing problems.
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children must be between the ages of 6-12 years of age
- •Meet criteria for clinical levels of externalizing problems on the SDQ
- •Parent(s) able to attend four sessions of parent meetings
排除标准
- •Solely emotional problems and non-clinical problem levels (as assessed by the SDQ)
- •Primary diagnosis of psychosis or eating disorders (as assessed by KSADS-PL)
- •Risk for suicide and/or severe violence risk (as assessed by KSADS-PL)
- •Current enrollment in another psychosocial treatment
- •Intellectual disability or major developmental delay (e.g. moderate/severe autism spectrum disorder) (as assessed by KSADS-PL & WASI)
- •Families with high risk of domestic abuse
- •Parents with acute psychosis (as assessed by SCID)
- •Parents with severe substance abuse and dependence (as assessed by SCID)
- •Parents with intellectual disability (as assessed by WASI)
- •Parents with acute risk of harm to self and others (as assessed by SCID)
结局指标
主要结局
Turgay DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) Disruptive Behavior Disorders Rating Scale (T-DSM-IV-S; Turgay, 1994)
时间窗: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
Turgay DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) Disruptive Behavior Disorders Rating Scale (T-DSM-IV-S; Turgay, 1994) is based on DSM-IV diagnostic criteria and examines hyperactivity/impulsivity, inattention, opposition-defiance, and conduct disorder. Symptoms are scored on a four-point Likert scale (0= not at all, 1= just a little, 2= quite a bit, and 3= very much). T-DSM-IV-S has shown good reliability and validity.
Strengths and Difficulties Questionnaire - Parent version (SDQ-P; Goodman, 2001)
时间窗: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
Strengths and Difficulties Questionnaire - Parent version (SDQ-P; Goodman, 2001) is a 25-item scale that asks parents to rate their children's emotional and behavioral difficulties on a 3-point Likert scale, ranging from 0 = not true to 2 = very true. The questionnaire is composed of five subscales: Emotional Symptoms, Conduct Problems, Hyperactivity-Inattention, Peer Problems and Prosocial. In addition, the SDQ-P yields Internalizing Difficulties, Externalizing Difficulties and Total Difficulties scale scores. SDQ-P was demonstrated to be a valid and reliable scale for use in Turkish children and adolescents (Yalın et al., 2013).
次要结局
- The Emotion Awareness Questionnaire (EAQ-30; Rieffe et al., 2008)(Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3))
- The Children's Global Assessment Scale (CGAS; Schaffer et al., 1983)(Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2))
- Emotion Regulation Checklist (ERC; Shields & Cicchetti, 1997)(Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3))
- Parental Stress Index - Short Form (PSI-SF; Abidin, 1983)(Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3))
- Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)(Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3))
- Me and My Feelings Questionnaire (M&MF; Deighton et al., 2013)(Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3))
研究者
Sibel Halfon
Associate Professor
Istanbul Bilgi University