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临床试验/NCT01948167
NCT01948167已完成不适用

Bending Adolescent Depression Trajectories Through Personalized Prevention

Children's Hospital of Philadelphia8 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
205
试验地点
8
主要终点
Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)

研究概览

简要总结

Investigators will combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence.

详细描述

Investigators will innovatively combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence. A randomized controlled trial will examine the benefits of matching youth to two depression prevention programs of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) and Coping with Stress (CWS) for the prevention of depression in adolescents. These two programs are designed to address distinct risk factors for depression - CWS addresses cognitive risks and IPT-AST addresses interpersonal risks. A total of 210 participants across two sites, University of Denver and Rutgers University, will be stratified on cognitive and interpersonal risk and randomized to the two conditions. The goals of the study are to (1) demonstrate that prevention programs can modify depression trajectories among youth by examining within person changes in trajectories over time (three years before and three years after the prevention programs) and by comparing trajectories of prevention youth with changes in same aged cohorts; (2) evaluate a personalized prevention approach to bending depression trajectories by matching and mismatching youth to either CWS or IPT-AST based on individual risk profiles; (3) examine mechanisms of bending depression trajectories and test whether the prevention programs operate via their hypothesized processes; and (4) explore how genetic susceptibility, emotion regulation, and temperament may affect individual response to IPT-AST and CWS. By implementing evidence-based prevention programs after 3-years of prospective naturalistic data collection, this study will contribute essential data on personalized medicine and altering developmental trajectories of first-onset depression.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Currently in the 6th to 11th grades
  • Adolescent and parent must be English-speaking
  • Parental consent and adolescent consent

排除标准

  • Presence of current Major Depressive Disorder, dysthymia, bipolar disorder, or significant psychosis
  • Suicide attempt in the past week or significant suicidal ideation in the past week
  • Presence of significant psychopathology or significant pervasive developmental delays that would make the group inappropriate

结局指标

主要结局

Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)

时间窗: 36-months post-intervention

Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.

Presence of a Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)

时间窗: Post intervention (approximately 3 months post baseline)

Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.

Children's Depression Inventory (CDI)

时间窗: 36-months post-intervention

Self-reported depression scores

次要结局

  • Children's Global Assessment Scale (CGAS)(36-months followup)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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