Interpersonal Psychotherapy for Adolescent Girls (IPT)
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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 |
- 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 |
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| Contact: Sheree Toth, PhD | 585-275-2991 | |
| Contact: Jody Todd Manly, PhD | 585-275-2991 |
| 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 | |
| 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: | December 3, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Rochester:
|
Depression Adolescents |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013