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

Phase 3

Completed

• Conditions: Anxiety; Depression
• Interventions: Behavioral: Adolescent only Penn Resiliency Program (Adolescent PRP); Behavioral: Parent Penn Resiliency Program (Parent PRP)

• Registration Number: NCT00360451
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2006-08-02
• Study First Submitted QC: 2006-08-02
• Study First Posted: 2006-08-04
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2008-08
• Last Update Submitted: 2015-09-09
• Last Update Posted: 2015-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Adolescent only Penn Resiliency Program (Adolescent PRP)	Adolescent plus parent Penn Resiliency Program
2	Parent Penn Resiliency Program (Parent PRP)	Adolescent plus parent Penn Resiliency Program
1	Adolescent only Penn Resiliency Program (Adolescent PRP)	Adolescent only Penn Resiliency Program

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States