Effectiveness of School-Based Cognitive Behavioral Therapy in Preventing Depression in Young Adolescents

September 9, 2015 updated by: University of Pennsylvania

Preventing Depression in School Children

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Adolescent only Penn Resiliency Program
Behavioral: Adolescent only Penn Resiliency Program (Adolescent PRP)
In adolescent PRP, students learn both cognitive skills (recognizing the link between beliefs and emotions, challenging negative beliefs with evidence, making accurate attributions for events, and accurately assessing the ramifications of negative events) and behavioral problem-solving skills (decision making, assertiveness and negotiation, social skills, and relaxation).
Experimental: 2
Adolescent plus parent Penn Resiliency Program
Behavioral: Adolescent only Penn Resiliency Program (Adolescent PRP)
In adolescent PRP, students learn both cognitive skills (recognizing the link between beliefs and emotions, challenging negative beliefs with evidence, making accurate attributions for events, and accurately assessing the ramifications of negative events) and behavioral problem-solving skills (decision making, assertiveness and negotiation, social skills, and relaxation).
Behavioral: Parent Penn Resiliency Program (Parent PRP)
Parent PRP teaches parents to model and reinforce the skills taught in the adolescent program.
No Intervention: 3
Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adolescents' depressive symptoms by self-report
Time Frame: Measured at baseline, post-treatment, and 6-month follow-ups
Measured at baseline, post-treatment, and 6-month follow-ups
Adolescents' symptoms of anxiety by self-report
Time Frame: Measured at baseline, post-treatment, and 6-month follow-ups
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
Measured at baseline and 6, 18, and 30-month follow-ups

Secondary Outcome Measures

Outcome Measure
Time Frame
Adolescents' externalizing symptoms by teacher report
Time Frame: Measured at baseline and 6, 18, and 30-month follow-ups
Measured at baseline and 6, 18, and 30-month follow-ups
Adolescents' attributional style by self-report
Time Frame: Measured at baseline and 6, 18, and 30-month follow-ups
Measured at baseline and 6, 18, and 30-month follow-ups
Parental depression by self-report
Time Frame: Measured at baseline and 6, 18, and 30-month follow-ups
Measured at baseline and 6, 18, and 30-month follow-ups
Parental anxiety by self-report
Time Frame: Measured at baseline and 6, 18, and 30-month follow-ups
Measured at baseline and 6, 18, and 30-month follow-ups
Parental attributional style by self-report
Time Frame: Measured at baseline and 6, 18, and 30-month follow-ups
Measured at baseline and 6, 18, and 30-month follow-ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Martin E.P. Seligman, PhD, Positive Psychology Center, University of Pennsylvania
  • Study Director: Jane E. Gillham, PhD, Swarthmore College & University of Pennsylvania
  • Study Director: Karen J. Reivich, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

August 2, 2006

First Submitted That Met QC Criteria

August 2, 2006

First Posted (Estimate)

August 4, 2006

Study Record Updates

Last Update Posted (Estimate)

September 10, 2015

Last Update Submitted That Met QC Criteria

September 9, 2015

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01 MH0522070
  • DSIR CT-P (Other Identifier: NIMH)
  • 5R01MH052270 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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