NCT01534377

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 16, 2012

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

6.9 years

First QC Date

February 2, 2012

Last Update Submit

August 2, 2018

Conditions

Keywords

DepressionAdolescents

Outcome Measures

Primary Outcomes (1)

  • Change in adolescent depressive symptoms from baseline to 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

Study Arms (2)

Interpersonal Psychotherapy

EXPERIMENTAL

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

Behavioral: Interpersonal Psychotherapy for Adolescents

Enhanced Care

EXPERIMENTAL

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

Interventions

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.

Also known as: IPT-A
Interpersonal Psychotherapy
Enhanced CareBEHAVIORAL

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

Also known as: EC
Enhanced Care

Eligibility Criteria

Age13 Years - 15 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mt. Hope Family Center

Rochester, New York, 14608, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sheree Toth, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR
  • Dante Cicchetti, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Mt. Hope Family Center

Study Record Dates

First Submitted

February 2, 2012

First Posted

February 16, 2012

Study Start

July 1, 2011

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

August 3, 2018

Record last verified: 2018-08

Locations