Interpersonal Psychotherapy for Adolescent Girls

Depression Clinical Trial

— IPT  

Official title:

Prevention of Depression in Maltreated and Nonmaltreated Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534377
• Other study ID #: 035457
• Secondary ID: 1R01MH091070-01A
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: June 2018

Study information

• Verified date: August 2018
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Mt. Hope Family Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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