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

Primary Purpose

Depression, Anxiety

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Adolescent only Penn Resiliency Program (Adolescent PRP)
Parent Penn Resiliency Program (Parent PRP)
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Prevention, Child, Adolescent, Parent

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

1

2

3

Arm Description

Adolescent only Penn Resiliency Program

Adolescent plus parent Penn Resiliency Program

Control

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adolescents' externalizing symptoms by teacher report
Adolescents' attributional style by self-report
Parental depression by self-report
Parental anxiety by self-report
Parental attributional style by self-report

Full Information

First Posted
August 2, 2006
Last Updated
September 9, 2015
Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00360451
Brief Title
Effectiveness of School-Based Cognitive Behavioral Therapy in Preventing Depression in Young Adolescents
Official Title
Preventing Depression in School Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
Prevention, Child, Adolescent, Parent

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Adolescent only Penn Resiliency Program
Arm Title
2
Arm Type
Experimental
Arm Description
Adolescent plus parent Penn Resiliency Program
Arm Title
3
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Behavioral
Intervention Name(s)
Adolescent only Penn Resiliency Program (Adolescent PRP)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Parent Penn Resiliency Program (Parent PRP)
Intervention Description
Parent PRP teaches parents to model and reinforce the skills taught in the adolescent program.
Primary Outcome Measure Information:
Title
Adolescents' depressive symptoms by self-report
Time Frame
Measured at baseline, post-treatment, and 6-month follow-ups
Title
Adolescents' symptoms of anxiety by self-report
Time Frame
Measured at baseline, post-treatment, and 6-month follow-ups
Title
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
Secondary Outcome Measure Information:
Title
Adolescents' externalizing symptoms by teacher report
Time Frame
Measured at baseline and 6, 18, and 30-month follow-ups
Title
Adolescents' attributional style by self-report
Time Frame
Measured at baseline and 6, 18, and 30-month follow-ups
Title
Parental depression by self-report
Time Frame
Measured at baseline and 6, 18, and 30-month follow-ups
Title
Parental anxiety by self-report
Time Frame
Measured at baseline and 6, 18, and 30-month follow-ups
Title
Parental attributional style by self-report
Time Frame
Measured at baseline and 6, 18, and 30-month follow-ups

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin E.P. Seligman, PhD
Organizational Affiliation
Positive Psychology Center, University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jane E. Gillham, PhD
Organizational Affiliation
Swarthmore College & University of Pennsylvania
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Karen J. Reivich, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Director
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22889296
Citation
Gillham JE, Reivich KJ, Brunwasser SM, Freres DR, Chajon ND, Kash-Macdonald VM, Chaplin TM, Abenavoli RM, Matlin SL, Gallop RJ, Seligman ME. Evaluation of a group cognitive-behavioral depression prevention program for young adolescents: a randomized effectiveness trial. J Clin Child Adolesc Psychol. 2012;41(5):621-39. doi: 10.1080/15374416.2012.706517. Epub 2012 Aug 13.
Results Reference
derived

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

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