Chicago Urban Resiliency Building (CURB): Phase 3 Clinical Trial in Primary Care to Engage Adolescents With a Web-based Depression Prevention Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- The Center for Epidemiological Studies of Depression (CES-D) Scale
研究概览
简要总结
The purpose of the study is to determine whether a culturally tailored, low-cost, primary care/internet based depression prevention intervention (CURB) is superior to wait-list control for African American and Hispanic youth in terms of depression-related outcomes. It is hypothesized that compared to teens in the wait-list control condition, teens in the CURB program will exhibit lower levels of depressed mood and/or more rapid changes in mood during the follow-up time.
详细描述
Additional aims and hypotheses are provided here:
Aim 2: To determine whether or not participants in the CURB primary care/Internet based depression prevention intervention will have a significantly lower cumulative incidence of any depressive episode at 3 months compared to adolescents in the usual care wait-list group.
Hypothesis 2: Compared to youth in the wait-list control condition, youth in the CURB program will have a lower incidence of depressive episodes at 6 month follow-up.
Aim 3: To determine whether CURB is sustainable in primary care from the perspective of health care professionals and primary care physicians in urban primary care settings.
Hypothesis 3: We hypothesize that providers will rate the intervention (by component) feasibility, acceptability, willingness to perform intervention and sustainability > 7 on a 1-10 scale (1, not feasible, 10 very feasible).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescents:
- •Male and female African American and Latino/a youth ages 13 -17 years old.
- •Adolescents with depressed mood (> 2 weeks duration) will be eligible unless they have already exceeded the diagnostic threshold for major depressive disorder or have a comorbid condition as defined in the exclusion criteria.
- •Parent of eligible adolescents
- •Primary Care Physicians (PCPs):
- •Physician at one of the four Mile Square Health Centers.
- •Health Care Professionals:
- •Employee at one of the four Mile Square Health Centers.
排除标准
- •Adolescents undergoing active treatment for depression [Active treatment for depression is defined as receiving anti-depressant medication or counseling within one year of remission of symptoms from the most recent episode]
- •Adolescents meeting probable diagnostic criteria for the following: Major depression, Substance and alcohol abuse, Panic attacks, Generalized anxiety disorder, Eating disorders, History of treatment for bi-polar disorder or schizophrenia or who are at elevated risk for suicide (often have suicidal thoughts or recent intent)
结局指标
主要结局
The Center for Epidemiological Studies of Depression (CES-D) Scale
时间窗: 0, 3, 6 months
Change in CESD from baseline Change in CESD scale between and within groups across the 6 months and for each assessment point
次要结局
- Vulnerability(6 months)
- Protective factors(6 months)
- Cost effective outcome measures(6 months)
研究者
Benjamin Van Voorhees, MD, MPH
Associate Professor of Pediatrics; Chief, Section of General Pediatrics and Adolescent Medicine; Director, TIKES Center Department of Pediatrics
University of Illinois at Chicago