Clinical trial NCT00360451: Effectiveness of School-Based Cognitive Behavioral Therapy in Preventing Depression in Young Adolescents
Official title: Preventing Depression in School Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Anxiety
Keywords: Prevention
Child
Adolescent
Parent
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-08-04
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Adolescents' depressive symptoms by self-report
timeFrame: Measured at baseline, post-treatment, and 6-month follow-ups
measure: Adolescents' symptoms of anxiety by self-report
timeFrame: Measured at baseline, post-treatment, and 6-month follow-ups
measure: Adolescents' symptoms of depression and anxiety, including clinical levels of symptoms, as assessed by diagnostic interview
timeFrame: Measured at baseline and 6, 18, and 30-month follow-ups
Secondary outcomes:
measure: Adolescents' externalizing symptoms by teacher report
timeFrame: Measured at baseline and 6, 18, and 30-month follow-ups
measure: Adolescents' attributional style by self-report
timeFrame: Measured at baseline and 6, 18, and 30-month follow-ups
measure: Parental depression by self-report
timeFrame: Measured at baseline and 6, 18, and 30-month follow-ups
measure: Parental anxiety by self-report
timeFrame: Measured at baseline and 6, 18, and 30-month follow-ups
measure: Parental attributional style by self-report
timeFrame: Measured at baseline and 6, 18, and 30-month follow-ups
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Positive Psychology Center, University of Pennsylvania
name: Martin E.P. Seligman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Swarthmore College & University of Pennsylvania
name: Jane E. Gillham, PhD
role: STUDY_DIRECTOR
affiliation: University of Pennsylvania
name: Karen J. Reivich, PhD
role: STUDY_DIRECTOR
References:
citation: Gillham JE, Reivich KJ, Brunwasser SM, Freres DR, Chajon ND, Kash-Macdonald VM, Chaplin TM, Abenavoli RM, Matlin SL, Gallop RJ, Seligman ME. Evaluation of a group cognitive-behavioral depression prevention program for young adolescents: a randomized effectiveness trial. J Clin Child Adolesc Psychol. 2012;41(5):621-39. doi: 10.1080/15374416.2012.706517. Epub 2012 Aug 13.