- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00270244
Group Interpersonal Psychotherapy for Depressed Adolescents in School-based Clinics
Group Interpersonal Psychotherapy for Depressed Adolescents (IPT-AG) in School-based Clinics
Study Overview
Status
Conditions
Detailed Description
Depression is a serious medical condition. It occurs in people of all ages, but only in the past two decades has depression in children and adolescents been taken seriously. Children and adolescents with depression may exhibit such behaviors as pretending to be sick, refusing to go to school or getting in trouble at school, clinging to a parent or worrying that the parent may die, sulking, or acting in a negative or grouchy manner. A previous study demonstrated that, when administered by clinicians in school-based clinics, individual interpersonal psychotherapy is effective in reducing depressive symptoms and improving global and social functioning. This study will assess the effectiveness of group interpersonal psychotherapy (IPT-AG) versus treatment as usual (TAU) in improving depressive symptoms of adolescents in school-based health clinics.
Participants in this 16-week single-blind study will be randomly assigned to receive either IPT-AG or TAU in a school-based clinic. Participants assigned to receive IPT-AG will attend two to three, 40-minute individual pre-group sessions, followed by 12, 90-minute group therapy sessions and two additional individual sessions-one midway through the group sessions and another upon completion of group therapy. TAU will consist of counseling sessions as regularly conducted by the school clinic social worker and/or referral to another agency. Study visits will occur at baseline and Weeks 4, 8, 12, and 16, or upon early termination. At the end of 16 weeks, participants assigned to receive IPT-AG will continue in a maintenance program in which they will receive IPT-AG once a month for an additional 6 months. All participants will also be assessed 6 and 12 months post-treatment to measure depressive symptoms, global and social functioning, satisfaction with care, and utilization of other services.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Meets diagnostic criteria for major depression, dysthymic disorder, depressive disorder not otherwise specified, or adjustment disorder with depressed mood
- Score of 24 or greater on the CES-D
- Score between 10 and 28 on the HRSD
- Score of 65 or less on the C-GAS
- English-speaking
- Parental or legal guardian consent to participate
Exclusion Criteria:
- Actively suicidal
- Score greater than 28 on the HRSD
- Mentally retarded
- Any life threatening medical illness
- Meets diagnostic criteria for current substance abuse, schizophrenia, or bipolar disorder
- Any evidence of psychosis, conduct disorder, or active eating disorder
- Currently in active treatment for depression
- Taking antidepressant medication at the time of baseline assessment
- Recent death of someone close
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Participants will receive treatment as usual
|
TAU will consist of counseling sessions as regularly conducted by the school clinic social worker and/or referral to another agency.
|
Experimental: 2
Participants will receive group interpersonal psychotherapy for depressed adolescents
|
Participants assigned to IPT-AG will attend two to three, 40-minute individual pre-group sessions, followed by 12, 90-minute group therapy sessions and two additional individual sessions-one midway through the group sessions and another upon completion of group therapy.
Sessions will focus on problems in interpersonal relationships.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Depressive symptoms as measured by the Hamilton Rating Scale for Depression (HRSD) and the Center for Epidemiological Studies-Depression Scale (CES-D)
Time Frame: Measured at Month 18
|
Measured at Month 18
|
Overall impairment, as measured by the Global Assessment Scale for Children (C-GAS)
Time Frame: Measured at Month 18
|
Measured at Month 18
|
Social functioning, as measured by the Social Adjustment Scale-Self-report (SAS-SR)
Time Frame: Measured at Month 18
|
Measured at Month 18
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Short Acculturation Scale for Hispanics, CES-D, HRSD, C-GAS, Clinical Global Improvement, Inventory of Parent and Peer Attachment, Family Adaptation and Cohesions Evaluation Scales III, and the Penn Helping Alliance Questionnaire-Revised
Time Frame: Measured at Month 18
|
Measured at Month 18
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Laura H. Mufson, PhD, New York State Psychiatric Institute-Columbia University College of Physicians and Surgeons
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 (Estimate)
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
- R01 MH73640, #5037
- DSIR 84-CTS (Division of Services and Intervention Research)
- R01MH073640 (U.S. NIH Grant/Contract)
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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