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临床试验/NCT01534377
NCT01534377已完成不适用

Prevention of Depression in Maltreated and Nonmaltreated Adolescents

University of Rochester2 个研究点 分布在 1 个国家目标入组 328 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
328
试验地点
2
主要终点
Change in adolescent depressive symptoms from baseline to post-intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
13 Years 至 15 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in adolescent depressive symptoms from baseline to post-intervention

时间窗: Baseline and 12 weeks, follow up at 1 year & again at 18 months 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheree Toth

Director Mt. Hope Family Center

University of Rochester

研究点 (2)

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