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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by National Institute of Mental Health (NIMH).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00360451
First received: August 2, 2006
Last updated: August 22, 2008
Last verified: August 2008
  Purpose

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


Condition Intervention Phase
Depression
Anxiety
Behavioral: Adolescent only Penn Resiliency Program (Adolescent PRP)
Behavioral: Parent Penn Resiliency Program (Parent PRP)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preventing Depression in School Children

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Adolescents' depressive symptoms by self-report [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-ups ] [ Designated as safety issue: No ]
  • Adolescents' symptoms of anxiety by self-report [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-ups ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adolescents' externalizing symptoms by teacher report [ Time Frame: Measured at baseline and 6, 18, and 30-month follow-ups ] [ Designated as safety issue: No ]
  • Adolescents' attributional style by self-report [ Time Frame: Measured at baseline and 6, 18, and 30-month follow-ups ] [ Designated as safety issue: No ]
  • Parental depression by self-report [ Time Frame: Measured at baseline and 6, 18, and 30-month follow-ups ] [ Designated as safety issue: No ]
  • Parental anxiety by self-report [ Time Frame: Measured at baseline and 6, 18, and 30-month follow-ups ] [ Designated as safety issue: No ]
  • Parental attributional style by self-report [ Time Frame: Measured at baseline and 6, 18, and 30-month follow-ups ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2002
Estimated Study Completion Date: March 2008
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360451

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martin E.P. Seligman, PhD, Positive Psychology Center, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00360451     History of Changes
Other Study ID Numbers: R01 MH0522070, DSIR CT-P
Study First Received: August 2, 2006
Last Updated: August 22, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Prevention
Child
Adolescent
Parent

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on August 20, 2014