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
- 1
- 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
排除标准
- •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.
- •Exclusion Criteria:
- •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)
研究组 & 干预措施
CURB Intervention
The intervention is made up of 14 internet modules based on behavioral activation, cognitive behavioral therapy, and interpersonal psychotherapy as well as motivational interviews in the primary care setting (to enhance behavior change). It is suggested that an adolescent navigates through 2 modules a week. The motivational interviews with the physicians occur directly before and after the adolescent is exposed to the website (at baseline and 3 months) in the providers office. The parents of the enrolled adolescents are also invited to navigate through their own, 3 module, parent internet program.
干预措施: CURB (Behavioral)
CURB Intervention (Wait List)
Same as the CURB Intervention arm, however, individuals assigned to this arm wait 3 months before receiving the intervention.
干预措施: CURB (Behavioral)
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