Comparison of Three Therapy-Based Interventions for Preventing Depression in Adolescents

Study Overview
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Brief Summary
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This study will compare Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), IPT-AST plus parent involvement (Enhanced IPT-AST), and Usual Care for the prevention of adolescent depression.

Detailed Description
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Depression is a serious medical illness that is difficult to diagnose and treat, especially in children and adolescents. Signs of depression in children may include the following behaviors: pretending to be sick; refusing to go to school; clinging to a parent; or worrying that a parent may die. Older children may sulk, behave inappropriately at school, act in a negative or grouchy manner, or feel misunderstood. Because normal behaviors vary from one childhood stage to another, it can be difficult to determine whether a child is going through a temporary phase or is suffering from depression. This study will compare IPT-AST, Enhanced IPT-AST, and Usual Care for the prevention of adolescent depression. Participation in this single-blind study will last approximately 21 months. Participants will be randomly assigned to receive either IPT-AST, Enhanced IPT-AST, or Usual Care for 12 weeks. IPT-AST is a school-based group intervention program that focuses on prevention, psychoeducation, and interpersonal skill-building. Enhanced IPT-AST will entail IPT-AST plus three parent-adolescent sessions. Usual Care will consist of standard treatments and will not include IPT-AST. Study visits will occur before and during the intervention at baseline and Weeks 6 and 12. Follow-up visits will occur 6, 12, and 18 months post-intervention. Study visit assessments will include depression symptoms, anxiety symptoms, psychiatric diagnoses, overall functioning, social adjustment, parent-child conflict, perceived support from parents and peers, and service utilization.

Official Title
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Prevention of Depression in Adolescents

Conditions
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Depression

Intervention / Treatment
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* Behavioral: IPT-AST
* Other: Enhanced IPT-AST
* Other: School counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between grades 7 and 10 in school Score of at least 16 on the Center for Epidemiologic Studies Short Depression Scale (CES-D) Currently experiencing at least 2 symptoms on the K-SADS depression section, one of which is either depressed mood, irritability, or an inability to feel pleasure during normal activities Score of at least 61 on the Children's Global Assessment Scale (CGAS), indicating mild to moderate impairment English-speaking Exclusion Criteria: Score of 15 or less on the CES-D scale Currently experiencing fewer than 2 depression symptoms on the K-SADS or 2 or more symptoms on the K-SADS with no report of depressed mood, irritability, or anhedonia Attempted suicide or self-mutilation in the year prior to study entry Current active suicidal ideation and/or history of a clinically significant suicidal behavior (i.e., with intent to die and high medical lethality) or repeated patterns of self-injurious behavior Current major depressive disorder or dysthymia as determined by K-SADS Current DSM-IV diagnosis of psychosis, substance abuse or dependence, bipolar disorder, obsessive compulsive disorder, post-traumatic stress disorder, panic disorder, or conduct disorder as determined by K-SADS Score of 60 or less on the CGAS, indicating substantial functional impairment

Ages Eligible for Study
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Minimum Age: 11 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<br>Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) | Behavioral: IPT-AST<br>* IPT-AST is a school based group treatment program that focuses on prevention, psychoeducation, and interpersonal skill building.<br>|
| Experimental: 2<br>Enhanced IPT-AST | Other: Enhanced IPT-AST<br>* Enhanced IPT-AST entails IPT-AST plus three parent-adolescent sessions.<br>|
| Active Comparator: 3<br>Typical school counseling | Other: School counseling<br>* Usual care consists of standard treatments, including individual counseling with guidance counselor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on the Center for Epidemiologic Studies Depression Scale |  | Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups | 
| Rating on Children's Global Assessment Scale |  | Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups | 
| Depression diagnoses on the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) diagnostic instrument |  | Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on the Conflict Behavior Questionnaire |  | Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups | 
| Score on the Social Adjustment Scale |  | Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups | 
| Score on the Perceived Social Support scale |  | Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups | 

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