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

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT00360451
Collaborator
National Institute of Mental Health (NIMH) (NIH)
400
1
3
66
6.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Adolescent only Penn Resiliency Program (Adolescent PRP)
  • Behavioral: Parent Penn Resiliency Program (Parent PRP)
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Preventing Depression in School Children
Study Start Date :
Sep 1, 2002
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Mar 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Adolescents' depressive symptoms by self-report [Measured at baseline, post-treatment, and 6-month follow-ups]

  2. Adolescents' symptoms of anxiety by self-report [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 [Measured at baseline and 6, 18, and 30-month follow-ups]

Secondary Outcome Measures

  1. Adolescents' externalizing symptoms by teacher report [Measured at baseline and 6, 18, and 30-month follow-ups]

  2. Adolescents' attributional style by self-report [Measured at baseline and 6, 18, and 30-month follow-ups]

  3. Parental depression by self-report [Measured at baseline and 6, 18, and 30-month follow-ups]

  4. Parental anxiety by self-report [Measured at baseline and 6, 18, and 30-month follow-ups]

  5. Parental attributional style by self-report [Measured at baseline and 6, 18, and 30-month follow-ups]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00360451
Other Study ID Numbers:
  • R01 MH0522070
  • 5R01MH052270
  • DSIR CT-P
First Posted:
Aug 4, 2006
Last Update Posted:
Sep 10, 2015
Last Verified:
Aug 1, 2008
Keywords provided by University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 10, 2015