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

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University of Pennsylvania

Status and phase

Completed
Phase 3

Conditions

Depression
Anxiety

Treatments

Behavioral: Adolescent only Penn Resiliency Program (Adolescent PRP)
Behavioral: Parent Penn Resiliency Program (Parent PRP)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00360451
R01 MH0522070
5R01MH052270 (U.S. NIH Grant/Contract)
DSIR CT-P

Details and patient eligibility

About

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

Full 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.

Enrollment

400 patients

Sex

All

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

400 participants in 3 patient groups

1
Experimental group
Description:
Adolescent only Penn Resiliency Program
Treatment:
Behavioral: Adolescent only Penn Resiliency Program (Adolescent PRP)
2
Experimental group
Description:
Adolescent plus parent Penn Resiliency Program
Treatment:
Behavioral: Parent Penn Resiliency Program (Parent PRP)
Behavioral: Adolescent only Penn Resiliency Program (Adolescent PRP)
3
No Intervention group
Description:
Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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