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Completed

NCT Number: NCT00360451

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

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

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adolescent only Penn Resiliency Program (Adolescent PRP)

Behavioral

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).

Parent Penn Resiliency Program (Parent PRP)

Behavioral

Parent PRP teaches parents to model and reinforce the skills taught in the adolescent program.

Primary outcomes

  1. Adolescents' depressive symptoms by self-report

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

  2. Adolescents' symptoms of anxiety by self-report

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

  3. 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 outcomes

  1. Adolescents' externalizing symptoms by teacher report

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

  2. Adolescents' attributional style by self-report

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

  3. Parental depression by self-report

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

  4. Parental anxiety by self-report

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

  5. Parental attributional style by self-report

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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Preventing Depression in School Children

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Aug 4, 2006
Registry last updated
Sep 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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