Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use- Electronic Spanish Platform
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool-Electronic Spanish Platform (TAPS-ESP) primary criterion validation against the modified World Mental Health Composite International Diagnostic Interview (CIDI) in Spanish
研究概览
简要总结
The goal of this study is to validate the TAPS-ESP as a screen and assessment that can be used in primary care for the screening and treatment of substance use.
详细描述
This Phase II study seeks to conduct further research to validate the TAPS-ESP as a Spanish language version of the screening and brief assessment and pave the way for its broad dissemination in the healthcare system. The investigators will use a novel application of a Type 1 hybrid effectiveness-implementation design, adapted to a screening validation study. The investigators will conduct a large-scale study to validate the TAPS-ESP against established diagnostic and biomarker metrics, replicating the design of the seminal English-language TAPS study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older
- •Current patient of the clinic
- •Spanish-language preferred
- •Ability to read Spanish
排除标准
- •Unable to provide informed consent
- •Inability to comprehend or read Spanish
- •Inability to self-administer the iPad tool due to physical limitations
研究组 & 干预措施
Self-Administration followed by Interviewer-Administered
Screening and validation of assessment tool translated into Spanish
干预措施: Screening (Other)
Interviewer-Administered followed by Self-Administration
Screening and validation of assessment tool translated into Spanish
干预措施: Screening (Other)
结局指标
主要结局
Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool-Electronic Spanish Platform (TAPS-ESP) primary criterion validation against the modified World Mental Health Composite International Diagnostic Interview (CIDI) in Spanish
时间窗: 1 year
TAPS-ESP is a two-stage screening and assessment tool that first screens for 4 broad substance abuse categories (tobacco, alcohol, prescription drug misuse, and illicit substances), then branches to the assessment for specific risks related to an array of substances. TAPS-ESP scores will be validated against the modified World Mental Health Composite International Diagnostic Interview (CIDI) including alcohol, tobacco, and 9 substance categories. The CIDI items mapped to the diagnostic criteria for each substance will serve as the primary criterion standard for validation of the TAPS-ESP. For detecting CIDI-derived substance use disorder (SUD) diagnosis, we will examine TAPS-ESP cut-points for the 4-item screener and the assessment in detecting problem severity defined by CIDI for detecting different tiers of substance use: Problem use (1+ criteria), SUD (2+ criteria), and moderate-to-severe SUD (4-11 criteria). Detection of SUD will be the primary outcome for each substance category.
次要结局
- CAGE (Cut Down, Annoyed, Guilty, Eye-Opener) for concurrent and convergent validity of the TAPS(1 year)
- Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) for concurrent and convergent validity of the TAPS Tool(1 year)
- Drug Abuse Screening Test (DAST-10) for concurrent and convergent validity of the TAPS Tool(1 year)
- Alcohol Use Disorders Identification Test (AUDIT) for concurrent and convergent validity of the TAPS(1 year)
- Fagerstrom Test for Nicotine Dependence (FTND) for concurrent and convergent validity of the TAPS(1 year)