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Bending Adolescent Depression Trajectories Through Personalized Prevention

2021年3月2日 更新者:Children's Hospital of Philadelphia
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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

205

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Colorado
      • Denver、Colorado、美国、80208
        • University of Denver
    • Illinois
      • Champaign、Illinois、美国、61820
        • University of Illinois Urbana Champaign
    • New Jersey
      • Piscataway、New Jersey、美国、08854
        • Rutgers University
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19146
        • Children's Hospital of Philadelphia

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 17年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Interpersonal Psychotherapy- Adolescent Skills Training
A group prevention program that includes a 60-minute pre-group session, 8 weekly 90-minute group sessions, a 60-minute mid-group session, and 3 60-minute booster sessions. IPT-AST focuses on psychoeducation and interpersonal skill-building to decrease interpersonal conflict and increase interpersonal support and competence.
其他名称:
  • IPT-AST
  • Teen Talk
实验性的:Coping with Stress
A group prevention program that consists of 8 acute 90-minute group sessions, 2 parent group sessions, and 3 continuation sessions lasting 60 minutes each. Participants are taught to apply cognitive techniques to their personal thoughts, with the goal of generating effective counterarguments to unrealistic negative beliefs.
其他名称:
  • CWS

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
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)
大体时间:Post intervention (approximately 3 months post baseline)
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
Post intervention (approximately 3 months post baseline)
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)
大体时间:6-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
6-months post-intervention
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)
大体时间:12-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
12-months post-intervention
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)
大体时间:18-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
18-months post-intervention
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)
大体时间:24-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
24-months post-intervention
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)
大体时间:30-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
30-months post-intervention
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)
大体时间:36-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
36-months post-intervention
Children's Depression Inventory (CDI)
大体时间:Post intervention (approximately 3 months after baseline)
Self-reported depression scores
Post intervention (approximately 3 months after baseline)
Children's Depression Inventory (CDI)
大体时间:6-months post-intervention
Self-reported depression scores
6-months post-intervention
Children's Depression Inventory (CDI)
大体时间:12-months post-intervention
Self-reported depression scores
12-months post-intervention
Children's Depression Inventory (CDI)
大体时间:18-months post-intervention
Self-reported depression scores
18-months post-intervention
Children's Depression Inventory (CDI)
大体时间:24-months post-intervention
Self-reported depression scores
24-months post-intervention
Children's Depression Inventory (CDI)
大体时间:30-months post-intervention
Self-reported depression scores
30-months post-intervention
Children's Depression Inventory (CDI)
大体时间:36-months post-intervention
Self-reported depression scores
36-months post-intervention

次要结果测量

结果测量
措施说明
大体时间
Children's Global Assessment Scale (CGAS)
大体时间:Post Intervention (approximately 3 months following baseline)
Assesses global functioning
Post Intervention (approximately 3 months following baseline)
Children's Global Assessment Scale (CGAS)
大体时间:6-months followup
Assesses global functioning
6-months followup
Children's Global Assessment Scale (CGAS)
大体时间:12-months followup
Assesses global functioning
12-months followup
Children's Global Assessment Scale (CGAS)
大体时间:18-months followup
Assesses global functioning
18-months followup
Children's Global Assessment Scale (CGAS)
大体时间:24-months followup
Assesses global functioning
24-months followup
Children's Global Assessment Scale (CGAS)
大体时间:30-months followup
Assesses global functioning
30-months followup
Children's Global Assessment Scale (CGAS)
大体时间:36-months followup
Assesses global functioning
36-months followup

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jami F Young, Ph.D.、Children's Hospital of Philadelphia

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年9月1日

初级完成 (实际的)

2019年8月1日

研究完成 (实际的)

2019年8月1日

研究注册日期

首次提交

2013年9月18日

首先提交符合 QC 标准的

2013年9月18日

首次发布 (估计)

2013年9月23日

研究记录更新

最后更新发布 (实际的)

2021年3月4日

上次提交的符合 QC 标准的更新

2021年3月2日

最后验证

2021年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 17-013831
  • R01MH077178 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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