A Randomized Controlled Trial of PCIT-ED for Preschool Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 229
- 试验地点
- 2
- 主要终点
- Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (KSADS-EC) MDD Core Symptom Score
研究概览
简要总结
Parent Child Interaction Therapy Emotion Development (PCIT-ED) will be conducted with a sample of preschoolers who exhibit symptoms of depression compared to a wait list (WL) control after which participants will receive the active treatment. PCIT-ED is an expansion of PCIT, a well-known, widely used and proven effective treatment for preschool disruptive disorders. To address early disturbances of mood and affect, a novel ED module was added based on empirical data in emotion development. The ED module targets parent emotion learning skills with the goal of training the parent to serve as a more effective emotion teacher and coach to the child. The goal of the ED module is to enhance the child's capacity for emotion recognition and regulation or "emotional competence." In order to test the efficacy of PCIT-ED, to estimate accurate effect sizes and to investigate mediators and moderators of treatment response participants will complete comprehensive pre-, interval, and post-assessments.
Preschoolers over 3 will be offered the option of enrolling in an add-on electroencephalography and magnetic resonance imagery study, to investigate neural changes associated with PCIT-ED.
Compared to those randomized to the WL, preschoolers who undergo PCIT-ED will show significantly increased rates of remission, greater reductions in MDD symptoms, and decreases in impairment; and will show significantly greater increases in emotional competence measured by the ability to accurately identify emotions in themselves and others and the ability to effectively regulate intense emotions. Compared to those on the WL, parents who undergo PCIT-ED will show significantly greater increases in emotion skill learning and reductions in MDD symptoms and parenting stress.
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
- 36 Months 至 83 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who meet all DSM-IV MDD symptom criteria (adjusted for development)
排除标准
- •Children with serious chronic medical illness
- •Children with Autistic Spectrum Disorders (based on clinical diagnosis or Social Responsiveness Scale scores which will be administered when there is suspicion of an ASD)
- •Children with significant speech delays
- •Children with general developmental delays or IQ < 70
- •Children with chronic neurological problems/illnesses
- •Children adopted after 12 months of age
- •Children on antidepressants
- •Children taking unstable doses of other psychotropic medications without antidepressant properties
- •Children participating in ongoing psychotherapy
- •Children in unstable placements (not with same caregiver for 6 months prior to study enrollment)
- •Children who are too ill to wait 18 weeks for treatment (e.g. having active suicidal ideation and/or in acute/serious distress)
结局指标
主要结局
Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (KSADS-EC) MDD Core Symptom Score
时间窗: completion of therapy (average of 20 weeks)
The Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (K-SADS-EC) is a semi-structured clinical interview for DSM-5 disorders adapted for use in children aged 3-6. The MDD core symptom score was the number of core MDD symptoms endorsed on the K-SADS-EC. These 9 symptoms were (1) depressed mood, (2) anhedonia, (3) insomnia/hypersomnia, (4) fatigue, (5) decreased concentration, (6) weight/appetite change, (7) psychomotor agitation/retardation, (8) worthlessness/guilt, (9) suicidal thoughts/behaviors. The range of possible values is 0-9, with 9 being the worst outcome.
次要结局
- Preschool Feelings Checklist-Scale Version (PFC-Scale) Score(completion of therapy (average of 20 weeks))
