Interpersonal Psychotherapy for Adolescent Girls (IPT)

August 2, 2018 updated by: Sheree Toth, University of Rochester

Prevention of Depression in Maltreated and Nonmaltreated Adolescents

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

328

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14608
        • Mt. Hope Family Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • EC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Baseline and 12 weeks, follow up at 1 year & again at 18 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Sheree Toth, PhD, University of Rochester
  • Principal Investigator: Dante Cicchetti, Ph.D., University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2011

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

February 2, 2012

First Submitted That Met QC Criteria

February 13, 2012

First Posted (Estimate)

February 16, 2012

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 035457
  • 1R01MH091070-01A1 (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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