Clinical trial NCT01534377: Interpersonal Psychotherapy for Adolescent Girls
Official title: Prevention of Depression in Maltreated and Nonmaltreated Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Adolescents
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-02-16
Enrollment: 328
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in adolescent depressive symptoms from baseline to post-intervention
timeFrame: Baseline and 12 weeks, follow up at 1 year & again at 18 months post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mt. Hope Family Center
state: New York
Study officials:
affiliation: University of Rochester
name: Sheree Toth, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Dante Cicchetti, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: