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Clinical Trials/NCT00360451
NCT00360451
Completed
Phase 3

Preventing Depression in School Children

University of Pennsylvania1 site in 1 country400 target enrollmentSeptember 2002

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Depression
Sponsor
University of Pennsylvania
Enrollment
400
Locations
1
Primary Endpoint
Adolescents' symptoms of anxiety by self-report
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 2002
End Date
March 2008
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

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

Outcomes

Primary Outcomes

Adolescents' symptoms of anxiety by self-report

Time Frame: 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

Time Frame: Measured at baseline and 6, 18, and 30-month follow-ups

Adolescents' depressive symptoms by self-report

Time Frame: Measured at baseline, post-treatment, and 6-month follow-ups

Secondary Outcomes

  • 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)

Study Sites (1)

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