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临床试验/NCT04399629
NCT04399629已完成不适用

Preschool Based Prevention Targeting Emotion Development in Young Children Facing Adversity

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2019年9月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
2
主要终点
McArthur Health and Behavior Questionnaire

研究概览

简要总结

A shorted form of the previously tested, Parent Child Interaction Therapy Emotion Development (PCIT-ED) will be conducted with a sample of preschoolers who exhibit symptoms of behavioral problems as rated by teacher. Children aged 3-7 will be randomized to a 12-week PCIT-ED delivered by trained therapists in the school setting or an on-line parent training called "Parenting Wisely (PW)". Children will have a 60% chance of being randomized to PCIT-ED and 40% to PW. The treatment will be provided to eligible children in the Jennings School District at the school site. 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- and post-assessments at Washington University School of Medicine Early Emotional Development Program.

Preschoolers over age 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 or PW.

Compared to those randomized to PW, we expect preschoolers who undergo PCIT-ED will show significantly increased rates of remission of behavioral problems, greater reductions in symptoms, and decreases in impairment. We hypothesize that they 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 PW, 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
48 Months 至 83 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Over the clinical threshold on the Teacher Report Form

排除标准

  • Major neurological disorder
  • Participating in active weekly individual or family therapy

结局指标

主要结局

McArthur Health and Behavior Questionnaire

时间窗: completion of therapy (average of 12 weeks)

The Health and Behavior Questionnaire was designed to assess children's mental health, physical health, and social and school functioning. The HBQ comprises multiple scales that measure children's symptoms (e.g., internalizing and externalizing symptoms and their subscales), physical health, social functioning (e.g., peer acceptance and rejection, prosocial behaviors), and school functioning (e.g., academic competence, school engagement). The HBQ also includes measures of children's health care utilization in the mental, physical, and school domains.

Teacher Report Form

时间窗: completion of therapy (average of 12 weeks)

This measure is used to obtain an overview of the child's behavior and functioning from the perspective of the teacher. The results of the form offer cross-informant comparisons in competencies, adaptive functioning and reported problems. This information is helpful for finding the child's strengths and where the child needs help.

次要结局

  • Parenting Styles and Dimensions Questionnaire(completion of therapy (average of 12 weeks))
  • Parent-Child Interaction: Marble Run and Drawing Task(completion of therapy (average of 12 weeks))
  • Eyberg Child Behavior Inventory(completion of therapy (average of 12 weeks))
  • Parenting Styles Questionnaire(completion of therapy (average of 12 weeks))
  • Coping with Children's Negative Emotions Scale(completion of therapy (average of 12 weeks))

研究者

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

Joan Luby, MD

Professor of Psychiatry

Washington University School of Medicine

研究点 (2)

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