Prevention of Depression in At-Risk Adolescents

Study Overview
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Brief Summary
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This study examines the impact of a group cognitive behavioral program aimed at preventing depressive disorders and symptoms in adolescents at risk for developing depression.

Detailed Description
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Depression is a prevalent, chronic, and impairing condition that is often undetected and becomes more difficult to treat as chronicity increases. There is an increasing need to conduct large-scale depression prevention studies in adolescents. This study evaluates a cognitive-behavioral prevention (CBP) program to determine its effectiveness in preventing depressive disorders in at-risk adolescents. The study also will ascertain the costs this intervention to inform attempts at future dissemination of the program in real world settings. Participants in this study are randomly assigned to receive either CBP for eight weekly and 6 monthly continuation sessions or usual care. Depressive symptoms and disorders, levels of functioning, and medical and mental health care utilization are assessed at baseline and again at 2, 8, 20, and 32 months after intake.

Official Title
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Prevention of Depression in At-Risk Adolescents

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Cognitive-behavioral prevention program
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A parent has had a depressive disorder during child's life Adolescent has had a past depressive episode or has current subsyndromal depressive symptoms measured on the Center for Epidemiological Studies Depression Scale (CES-D) Exclusion Criteria: adolescent or parent ever diagnosed with bipolar I or schizophrenia; adolescent has a current DSM-IV mood disorder diagnosis

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1= Cognitive behavioral prevention of depression program<br>Participants receive a group cognitive-behavioral prevention program, which involved 8 weekly sessions and 6 monthly sessions of CBT skills such as cognitive restructuring, problem-solving, assertivenss, and behavioral activation. Participants in this arm also were able to seek the same kinds of nonstudy treatments as described in the usual care arm. | Behavioral: Cognitive-behavioral prevention program<br>* Cognitive-behavioral prevention program includes 8 weekly and 6 monthly group sessions.<br>|
| Active Comparator: 2 = Usual care<br>Participants receive usual care, which involves any type of treatment (e.g., psychotherapy, counseling, pharmacotherapy). | Other: Usual care<br>* Participants receive usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of a probable or definite depressive episodes (i.e., Depression Symptom Rating greater or equal to 4) | a score of 4 or greater is considered an onset | Time to a score of 4 or higher between baseline and 9 months using survival analysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of depression-free days | Using the depression symptom ratings (DSR) (1-6), each week is given a score of 1 to 6; depression-free days are those with ratings of 1 or 2 on the DSR. | Measured continuously through Month 33 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent