Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use- Electronic Spanish Platform

Alcohol Abuse Clinical Trial

— TAPS-ESP  

Official title:

Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use- Electronic Spanish Platform

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05476588
• Other study ID #: 022-114
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: May 2025

Study information

• Verified date: July 2023
• Source: Baylor Research Institute
• Contact: Brittany Meredith, Masters
• Phone: (214) 265-3695
• Email: brittany.meredith[@]bswhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• Current patient of the clinic

• Spanish-language preferred

• Ability to read Spanish

Exclusion Criteria:

• Unable to provide informed consent

• Inability to comprehend or read Spanish

• Inability to self-administer the iPad tool due to physical limitations

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Prescription Drug Abuse
• Substance Use
• Substance-Related Disorders
• Tobacco Use

Intervention

Other:
• Screening
Screening and validation of assessment tool translated into Spanish

Locations

Country	Name	City	State
United States	Baylor Scott and White Community Care	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	COG Analytics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 year
Secondary	Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) for concurrent and convergent validity of the TAPS Tool	The ASSIST was developed for the World Health Organization to screen for alcohol, tobacco, and drug use in medical care settings. For each substance, the use dimensions include lifetime use, past 3 month use, urges or cravings to use, and adverse consequences from use, as well as concerns expressed by family or friends about use (lifetime, past 3 months), failed attempts to control, cut down, or stop use (lifetime, past 3 months), and drug injection (lifetime, past 3 months). The ASSIST provides substance-specific risk scores 9 substance classes, with scores of 1-3 corresponding to low risk, 4-26 (10-26 for alcohol) to moderate risk, and 27 or higher to high risk.	1 year
Secondary	Drug Abuse Screening Test (DAST-10) for concurrent and convergent validity of the TAPS Tool	The DAST-10 is a ten-item yes/no screen for general drug use problems (not including alcohol). Each item is worth one point, and respondents are tiered into risk categories based on score, with more intensive assessment recommended at a score of 6 or higher. It has been widely used in the substance use field, but does not distinguish between types of drugs used. A Spanish language version has been developed.	1 year
Secondary	CAGE (Cut Down, Annoyed, Guilty, Eye-Opener) for concurrent and convergent validity of the TAPS	The CAGE is a rapid alcoholism screening test comprised of four yes/no questions (Cut Down, Annoyed, Guilty, Eye-Opener) for which ONE yes answer to any of the four items indicates DSM-IV alcohol abuse or dependence. A Spanish language version was validated in both Spain and the US, where it performed well in identifying DSM-IV alcohol abuse or dependence among Latinx primary care patients.	1 year
Secondary	Alcohol Use Disorders Identification Test (AUDIT) for concurrent and convergent validity of the TAPS	The AUDIT is a 10-item questionnaire which covers the domains of alcohol consumption, drinking behavior, and alcohol-related problems. It was developed from a six-country World Health Organization collaborative project as a screening instrument for hazardous and harmful alcohol consumption. Responses to each of the 10 questions are scored according to a frequency rating of 0 (never) to 4 (daily), giving the entire questionnaire a possible score of 40. A score of 8 or more indicates harmful or hazardous alcohol use. A Spanish language version of the AUDIT is available.	1 year
Secondary	Fagerstrom Test for Nicotine Dependence (FTND) for concurrent and convergent validity of the TAPS	The FTND is comprised of six questions scored on a point system, with total scoring summing between 0 and 10. Higher scores indicate heavier reliance on nicotine. The FTDN has been widely used in the tobacco field for decades. It has been found to be internally consistent and an acceptable way to measure nicotine/tobacco dependency. The FTND has been translated into Spanish and validated.	1 year