Interpersonal Psychotherapy for Adolescent Girls (IPT)
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Psychotherapy for Adolescents
Enhanced Care
Sponsored by
About this trial
This is an interventional prevention trial for Depression focused on measuring Depression, Adolescents
Eligibility 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
Sites / Locations
- Mt. Hope Family Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Interpersonal Psychotherapy
Enhanced Care
Arm Description
Adolescents will receive Interpersonal Psychotherapy for the treatment and prevention of depression.
Adolescents will receive the Enhanced care model or care that they would typically receive in community setting to treat and prevent depression.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01534377
First Posted
February 2, 2012
Last Updated
August 2, 2018
Sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01534377
Brief Title
Interpersonal Psychotherapy for Adolescent Girls
Acronym
IPT
Official Title
Prevention of Depression in Maltreated and Nonmaltreated Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2011 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Adolescents
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
328 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interpersonal Psychotherapy
Arm Type
Experimental
Arm Description
Adolescents will receive Interpersonal Psychotherapy for the treatment and prevention of depression.
Arm Title
Enhanced Care
Arm Type
Experimental
Arm Description
Adolescents will receive the Enhanced care model or care that they would typically receive in community setting to treat and prevent depression.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy for Adolescents
Other Intervention Name(s)
IPT-A
Intervention Description
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
Intervention Name(s)
Enhanced Care
Other Intervention Name(s)
EC
Intervention Description
Adolescents will receive enhanced care which is consistent with care typically provided in community settings to treat and prevent depression.
Primary Outcome Measure Information:
Title
Change in adolescent depressive symptoms from baseline to post-intervention
Description
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
Time Frame
Baseline and 12 weeks, follow up at 1 year & again at 18 months post intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheree Toth, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dante Cicchetti, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mt. Hope Family Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14608
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Interpersonal Psychotherapy for Adolescent Girls
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