Interpersonal Psychotherapy for Adolescent Girls

NCT ID: NCT01534377

Last Updated: 2018-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Interpersonal Psychotherapy

Adolescents will receive Interpersonal Psychotherapy for the treatment and prevention of depression.

Group Type EXPERIMENTAL

Interpersonal Psychotherapy for Adolescents

Intervention Type BEHAVIORAL

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.

Enhanced Care

Adolescents will receive the Enhanced care model or care that they would typically receive in community setting to treat and prevent depression.

Group Type EXPERIMENTAL

Enhanced Care

Intervention Type BEHAVIORAL

Adolescents will receive enhanced care which is consistent with care typically provided in community settings to treat and prevent depression.

Interventions

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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.

Intervention Type BEHAVIORAL

Enhanced Care

Adolescents will receive enhanced care which is consistent with care typically provided in community settings to treat and prevent depression.

Intervention Type BEHAVIORAL

Other Intervention Names

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IPT-A EC

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Sheree Toth

Director Mt. Hope Family Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sheree Toth, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Dante Cicchetti, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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Mt. Hope Family Center

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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1R01MH091070-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

035457

Identifier Type: -

Identifier Source: org_study_id

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