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Interpersonal Psychotherapy for Adolescent Girls (IPT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Rochester
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sheree Toth, University of Rochester
ClinicalTrials.gov Identifier:
NCT01534377
First received: February 2, 2012
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

This study will evaluate the efficacy of Interpersonal Psychotherapy for Adolescents (IPT-A) for the treatment of depression and prevention of depression in maltreated and nonmaltreated girls between the ages of 13-15 years old.


Condition Intervention Phase
Depression
Behavioral: Interpersonal Psychotherapy for Adolescents
Behavioral: Enhanced Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Depression in Maltreated and Nonmaltreated Adolescents

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Change in adolescent depressive symptoms from baseline to post-intervention [ Time Frame: Baseline and 12 weeks, follow up at 1 year & again at 18 months post intervention ] [ Designated as safety issue: No ]
    To evaluate the efficacy of Interpersonal Psychotherapy for Adolescents (IPT-A) for decreasing depressive symptoms and preventing depression in low-income ethnically and culturally diverse adolescent girls with and without histories of child maltreatment


Estimated Enrollment: 350
Study Start Date: July 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interpersonal Psychotherapy
Adolescents will receive Interpersonal Psychotherapy for the treatment and prevention of depression.
Behavioral: Interpersonal Psychotherapy for Adolescents
Adolescents will receive IPT-A a manualized intervention for depression and prevention of depression that emphasizes current interpersonal relationships, focusing on their immediate social context.
Other Name: IPT-A
Experimental: Enhanced Care
Adolescents will receive the Enhanced care model or care that they would typically receive in community setting to treat and prevent depression.
Behavioral: Enhanced Care
Adolescents will receive enhanced care which is consistent with care typically provided in community settings to treat and prevent depression.
Other Name: EC

Detailed Description:

Child maltreatment poses a serious public health problem and heightens the risk of psychopathology across the life course. Adolescence also represents a peak time for the emergence of depressive disorders particularly in girls. Effective interventions to prevent and treat depression in low income adolescent girls with or without histories of maltreatment are needed.

Three groups will be recruited: Maltreated Depressive Symptoms (MDS), Nonmaltreated Depressive Symptoms (NDS), and a Nonmaltreated Nonsymptomatic Comparison (NNC), comparable in SES, race/ethnicity, and household composition. The MDS and NDS groups will be randomized into IPT-A or Enhanced Care (EC). Adolescent girls in these groups will receive 13 sessions of therapy. Girls in the NNC group will only complete research visits.

Research assessments will be conducted at T1 (baseline/prior to intervention), T2 (6-weeks mid-intervention), T3 (end of intervention), T4 (1-year post) and T5 (18 months post). Girls and their mothers will participate in these research sessions. A multi-level-of-analysis approach, integrating genotyping, hormone assays, cognitive testing, adolescent- and maternal-report, mother-teen observation, and DHS and school records will be utilized to assess the effectiveness of the interventions.

  Eligibility

Ages Eligible for Study:   13 Years to 15 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • girls
  • ages 13-15 years old
  • low SES status
  • live in Rochester or surrounding counties
  • girls in the maltreated depressive symptom group will have CPS-documented child maltreatment
  • girls in the nonmaltreated depressive symptom group will not have CPS- documented child maltreatment
  • girls in the nonmaltreated nonsymptomatic comparison group will have no current or past mental illness and no documented child maltreatment

Exclusion Criteria:

  • taking antidepressants or prescription medications for anxiety
  • already receiving mental health treatment
  • actively suicidal
  • diagnosed with a severe mental disorder
  • abusing drugs or alcohol
  • evidence of compromised cognitive ability
  • evidence of a pervasive developmental disorder
  • evidence of a major physical or neurological disorder
  • non-English speaking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534377

Contacts
Contact: Sheree Toth, PhD 585-275-2991
Contact: Jody Todd Manly, PhD 585-275-2991

Locations
United States, New York
Mt. Hope Family Center Recruiting
Rochester, New York, United States, 14608
Contact: Sheree Toth, PhD    585-275-2991      
Principal Investigator: Sheree Toth, PhD         
Sub-Investigator: Jody Todd Manly, PhD         
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Sheree Toth, PhD University of Rochester
Principal Investigator: Dante Cicchetti, Ph.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Sheree Toth, Director Mt. Hope Family Center, University of Rochester
ClinicalTrials.gov Identifier: NCT01534377     History of Changes
Other Study ID Numbers: 035457, 1R01MH091070-01A1
Study First Received: February 2, 2012
Last Updated: September 2, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Rochester:
Depression
Adolescents

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 25, 2014