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临床试验/NCT00360451
NCT00360451已完成3 期

Preventing Depression in School Children

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2002年9月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
400
试验地点
2
主要终点
Adolescents' symptoms of anxiety by self-report

研究概览

简要总结

This study will evaluate the effectiveness of the Penn Resiliency Program, a school-based cognitive behavioral depression prevention program for young adolescents.

详细描述

Depression is a serious illness that affects a person's mood, thoughts, and physical well-being. Research suggests that approximately one in five children meets criteria for a major depressive episode by the end of high school. These children are at increased risk for a wide range of social, psychological, physical, and achievement-related problems. Thus, the potential benefits of effective and highly transportable depression prevention programs are enormous. The Penn Resiliency Program (PRP) is a school-based group intervention that teaches cognitive behavioral and social problem-solving skills to young adolescents. This study will examine the effectiveness of PRP in preventing symptoms of depression and anxiety among a group of young adolescents.

Participants in this open label study will be randomly assigned to one of three groups: adolescent only PRP, adolescent plus parent PRP, or no treatment control. In adolescent PRP, students will be taught cognitive and behavioral problem solving skills by school counselors and teachers. Parents in PRP will be taught to model and reinforce the skills taught in the adolescent program. Participants in the adolescent program will attend twelve 90-minute group sessions after school hours. Participants in the parent program will attend six 90-minute group sessions. Adolescent participants will attend booster sessions twice per year for 2 to 3 years after the initial treatment has ended. Parents will attend one booster session per year during the follow-up phase. Adolescents' depression and anxiety symptoms will be assessed through questionnaires at baseline, post-treatment, and 6-month intervals for 2 to 3 years following the intervention. Adolescents will also complete questionnaires about their coping behaviors, feelings of hopelessness, and several other outcomes related to depression and anxiety in adolescence. Data will be collected once per year from parents and teachers. Adolescent participants will also be assessed for depression and anxiety disorders each year the child is in the study.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Student with above average levels of depression and anxiety symptoms (students with average or below average symptoms will be enrolled into the study space permitting)

排除标准

  • Not a student in a participating school
  • Not a student in grades six through eight

结局指标

主要结局

Adolescents' symptoms of anxiety by self-report

时间窗: Measured at baseline, post-treatment, and 6-month follow-ups

Adolescents' symptoms of depression and anxiety, including clinical levels of symptoms, as assessed by diagnostic interview

时间窗: Measured at baseline and 6, 18, and 30-month follow-ups

Adolescents' depressive symptoms by self-report

时间窗: Measured at baseline, post-treatment, and 6-month follow-ups

次要结局

  • Parental depression by self-report(Measured at baseline and 6, 18, and 30-month follow-ups)
  • Parental anxiety by self-report(Measured at baseline and 6, 18, and 30-month follow-ups)
  • Parental attributional style by self-report(Measured at baseline and 6, 18, and 30-month follow-ups)
  • Adolescents' externalizing symptoms by teacher report(Measured at baseline and 6, 18, and 30-month follow-ups)
  • Adolescents' attributional style by self-report(Measured at baseline and 6, 18, and 30-month follow-ups)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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