Preventing Depression in the Children of Depressed African American Mothers
2014年10月17日 更新者：Rhonda Boyd、Children's Hospital of Philadelphia
Children of Depressed Mothers: Culture & Prevention
The purpose of the study is to adapt and test the Preventive Intervention Project for urban African American mothers with depression and their children.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
34
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104
- The Children's Hospital of Philadelphia
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
8年 至 14年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Mothers:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Children:
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Adapted PIP
Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Prevention Intervention Project. |
Eight 1-hour sessions focused on psychoeducation, coping with stress, and cognitive-behavioral strategies.
The sessions were tailored as required to meet the clinical and cultural needs of each family; other family members, such as fathers, spouses, and grandparents, were invited to participate in the intervention.
|
|
有源比较器：Lecture
Mothers received psychoeducation about depression. The intervention was psychoeducation. |
Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Children Depression Inventory (CDI)
大体时间：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.
|
Measured at baseline and at post-treatment (8 weeks after baseline)
|
|
Multidimensional Anxiety Scale for Children (MASC)
大体时间：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.
|
Measured at baseline and post-treatment (8 weeks after baseline)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Understanding Mood Disorders Questionnaire (UMDQ)
大体时间：Measured at baseline and post-treatment (8 weeks after baseline)
|
Understanding Mood Disorders Questionnaire (UMDQ; Gavazzi, Fristad, & Law, 1997) measures attributions and knowledge of symptoms, course, and treatment of mood disorders and a symptom checklist.
It has 39 items and two subscales.
A range of total score is 0 to 59.
The first 20 questions are true/false questions and correct responses are scored 2 points each.
Nineteen questions are a checklist of symptoms and correct identification of those depression and manic symptoms are scored 1 point each.
All items are summed for a total score.
Higher scores indicate greater knowledge of mood disorders.
Both maternal and child reporters completed this measure.
|
Measured at baseline and post-treatment (8 weeks after baseline)
|
|
Child's Report on Parental Behavior Inventory (CRPBI)
大体时间：Measured at baseline and post-treatment (8 weeks after baseline)
|
Child's Report on Parental Behavior Inventory (CRPBI; Schludermann & Schludermann, 1970) assesses children's and parents' perceptions of parental acceptance, permitting psychological autonomy, and level of parental control.
The 10-item acceptance scale which assesses parental warmth was administered.
The acceptable scale has items scored from 1 to 3 (not like me, somewhat like me, a lot like me).
Items are summed with a total range is 10 to 30.
Higher scores represents greater warmth exhibited by mother to child.
Separate forms are available for both child and parent report.
|
Measured at baseline and post-treatment (8 weeks after baseline)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Rhonda C. Boyd, PhD、Children's Hospital of Philadelphia
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年2月1日
初级完成 (实际的)
2009年2月1日
研究完成 (实际的)
2009年2月1日
研究注册日期
首次提交
2009年5月19日
首先提交符合 QC 标准的
2009年5月19日
首次发布 (估计)
2009年5月20日
研究记录更新
最后更新发布 (估计)
2014年10月20日
上次提交的符合 QC 标准的更新
2014年10月17日
最后验证
2014年10月1日
更多信息
与本研究相关的术语
其他研究编号
- 2004-10-4041
- K01MH068619 (美国 NIH 拨款/合同)
- DSIR 8K-RTCT (NIMH DSIR)
- IRB NO: 2004-10-4041 (其他标识符：IRB No.)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Prevention Intervention Project的临床试验
-
UConn HealthUniversity of Texas at Austin; Oregon Social Learning Center邀请报名
-
London School of Hygiene and Tropical MedicineChildren's Investment Fund Foundation; Splash完全的
-
University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
-
University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人
-
University of North Carolina, Chapel HillCenters for Disease Control and Prevention完全的
-
Johns Hopkins UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)完全的