- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00258752
Comparison of Three Therapy-Based Interventions for Preventing Depression in Adolescents
Prevention of Depression in Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Jersey
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Piscataway, New Jersey, United States, 08554
- Rutgers University
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New York
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New York, New York, United States, 10032
- New York State Psychiatric Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST)
|
IPT-AST is a school based group treatment program that focuses on prevention, psychoeducation, and interpersonal skill building.
|
Experimental: 2
Enhanced IPT-AST
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Enhanced IPT-AST entails IPT-AST plus three parent-adolescent sessions.
|
Active Comparator: 3
Typical school counseling
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Usual care consists of standard treatments, including individual counseling with guidance counselor.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Score on the Center for Epidemiologic Studies Depression Scale
Time Frame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
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Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
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Rating on Children's Global Assessment Scale
Time Frame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
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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
Time Frame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
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Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Score on the Conflict Behavior Questionnaire
Time Frame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
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Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
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Score on the Social Adjustment Scale
Time Frame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
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Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
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Score on the Perceived Social Support scale
Time Frame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
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Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jami F. Young, PhD, Rutgers University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K23MH071320 (U.S. NIH Grant/Contract)
- DSIR 8K-RTCT (NIMH DSIR)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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