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临床试验/NCT00904917
NCT00904917已完成1 期

Children of Depressed Mothers: Culture & Prevention

Children's Hospital of Philadelphia2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2008年2月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
34
试验地点
2
主要终点
Multidimensional Anxiety Scale for Children (MASC)

研究概览

简要总结

The purpose of the study is to adapt and test the Preventive Intervention Project for urban African American mothers with depression and their children.

详细描述

Abstract

Background: There is limited representation of ethnic minorities in preventive interventions for the generational impact of maternal depression.

Methods: The Preventive Intervention Project (PIP) was adapted to be culturally and contextually relevant for urban African American mothers with depression and their children. A pilot clinical trial (PIP vs. lecture) was conducted.

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
Single (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • African American
  • Primary current or past-year diagnostic and statistical manual (DSM-IV) diagnosis of Major Depressive Disorder, Dysthymic Disorder, or Depressive Disorder not otherwise specified
  • Parent or guardian and primary caregiver of a child 8 to 14 years old
  • Resided at least part time for the past year with the targeted child
  • May be receiving psychopharmacological treatment, psychosocial services, or both

排除标准

  • Current or lifetime history of schizophrenia
  • Current or lifetime history of bipolar disorder
  • Current or past-year diagnosis of alcohol or drug dependency
  • Serious medical disorder, neurological disorder, condition, or chronic pain that prevents participation
  • Documented mental retardation
  • Current suicide risk sufficient to preclude outpatient treatment
  • Inclusion Criteria:
  • Have an African American mother with a depressive disorder
  • 8 to 14 years old
  • Reside at least part time with mother
  • Exclusion Criteria:
  • Currently in treatment for depression or an anxiety disorder
  • Presence of a medical or psychiatric condition contraindicating study intervention, such as mental retardation, suicidality, or pervasive developmental disorder

结局指标

主要结局

Multidimensional Anxiety Scale for Children (MASC)

时间窗: Measured at baseline and post-treatment (8 weeks after baseline)

Multidimensional Anxiety Scale for Children (MASC; March et al., 1997) is a self-report instrument that measures a broad range of anxiety symptoms in youth. The MASC consists of 39 items using a 4-point Likert scale that are distributed across four major factors, three of which can be parsed into two subfactors each. Main and subfactors include (1) physical symptoms (tense/restless and somatic/autonomic), (2) social anxiety (humiliation/rejection and public performance fears), (3) harm avoidance (perfectionism and anxious coping), and (4) separation anxiety. Scores are summed and converted to T-scores. The total T score ranges from 25 to 90 with higher scores representing greater levels of anxiety.

Children Depression Inventory (CDI)

时间窗: Measured at baseline and at post-treatment (8 weeks after baseline)

Children Depression Inventory (CDI; Kovacs, 1992) is a widely-used self-report scale of depressive symptoms suitable for use by youth ranging from 7 to 17 years. The CDI is a 27-item scale that is self-rated and symptom-oriented. The 27 items on the assessment are grouped into five major factor areas. The item score are rated 0-2 with a total scores summed and converted to T scores. The total T score ranges from 33 to 100 with high scores indicating higher levels of depressive symptoms.

次要结局

  • Understanding Mood Disorders Questionnaire (UMDQ)(Measured at baseline and post-treatment (8 weeks after baseline))
  • Child's Report on Parental Behavior Inventory (CRPBI)(Measured at baseline and post-treatment (8 weeks after baseline))

研究者

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

Rhonda Boyd

Associate Professor

Children's Hospital of Philadelphia

研究点 (2)

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