Group Interpersonal Psychotherapy for Depressed Adolescents in School-based Clinics

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00270244
First received: December 21, 2005
Last updated: December 27, 2011
Last verified: December 2011

December 21, 2005
December 27, 2011
December 2005
January 2008   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • Overall impairment, as measured by the Global Assessment Scale for Children (C-GAS) [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
  • Social functioning, as measured by the Social Adjustment Scale-Self-report (SAS-SR) [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
  • Depressive symptoms as measured by the Hamilton Rating Scale for Depression (HRSD) and the Center for Epidemiological Studies-Depression Scale (CES-D)
  • Overall impairment, as measured by the Global Assessment Scale for Children (C-GAS)
  • Social functioning, as measured by the Social Adjustment Scale-Self-report (SAS-SR); measured at Months 6 and 12 post-treatment
Complete list of historical versions of study NCT00270244 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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
Not Provided
Not Provided
 
Group Interpersonal Psychotherapy for Depressed Adolescents in School-based Clinics
Group Interpersonal Psychotherapy for Depressed Adolescents (IPT-AG) in School-based Clinics

This study will assess the effectiveness of group interpersonal psychotherapy (IPT-AG) versus treatment as usual (TAU) in improving the treatment of depressed adolescents in school-based health clinics.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • Behavioral: Group interpersonal psychotherapy for depressed adolescents (IPT-AG)
    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.
  • Behavioral: Treatment as usual (TAU)
    TAU will consist of counseling sessions as regularly conducted by the school clinic social worker and/or referral to another agency.
  • Active Comparator: 1
    Participants will receive treatment as usual
    Intervention: Behavioral: Treatment as usual (TAU)
  • Experimental: 2
    Participants will receive group interpersonal psychotherapy for depressed adolescents
    Intervention: Behavioral: Group interpersonal psychotherapy for depressed adolescents (IPT-AG)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Female
12 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00270244
R01 MH73640, #5037, R01MH073640, DSIR 84-CTS
Yes
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Principal Investigator: Laura H. Mufson, PhD New York State Psychiatric Institute-Columbia University College of Physicians and Surgeons
New York State Psychiatric Institute
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP