Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use- Electronic Spanish Platform (TAPS-ESP)
Primary Purpose
Tobacco Use, Alcohol Abuse, Prescription Drug Abuse
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screening
Sponsored by
About this trial
This is an interventional screening trial for Tobacco Use
Eligibility Criteria
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
Sites / Locations
- Baylor Scott and White Community CareRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Self-Administration followed by Interviewer-Administered
Interviewer-Administered followed by Self-Administration
Arm Description
Screening and validation of assessment tool translated into Spanish
Screening and validation of assessment tool translated into Spanish
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05476588
First Posted
July 1, 2022
Last Updated
July 25, 2023
Sponsor
Baylor Research Institute
Collaborators
COG Analytics
1. Study Identification
Unique Protocol Identification Number
NCT05476588
Brief Title
Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use- Electronic Spanish Platform
Acronym
TAPS-ESP
Official Title
Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use- Electronic Spanish Platform
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute
Collaborators
COG Analytics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use, Alcohol Abuse, Prescription Drug Abuse, Substance Use
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, two-group design.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Self-Administration followed by Interviewer-Administered
Arm Type
Active Comparator
Arm Description
Screening and validation of assessment tool translated into Spanish
Arm Title
Interviewer-Administered followed by Self-Administration
Arm Type
Active Comparator
Arm Description
Screening and validation of assessment tool translated into Spanish
Intervention Type
Other
Intervention Name(s)
Screening
Intervention Description
Screening and validation of assessment tool translated into Spanish
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) for concurrent and convergent validity of the TAPS Tool
Description
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.
Time Frame
1 year
Title
Drug Abuse Screening Test (DAST-10) for concurrent and convergent validity of the TAPS Tool
Description
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.
Time Frame
1 year
Title
CAGE (Cut Down, Annoyed, Guilty, Eye-Opener) for concurrent and convergent validity of the TAPS
Description
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.
Time Frame
1 year
Title
Alcohol Use Disorders Identification Test (AUDIT) for concurrent and convergent validity of the TAPS
Description
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.
Time Frame
1 year
Title
Fagerstrom Test for Nicotine Dependence (FTND) for concurrent and convergent validity of the TAPS
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brittany Meredith, Masters
Phone
(214) 265-3695
Email
brittany.meredith@bswhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Martha Buendia, Bachelors
Phone
(214) 265-3695
Email
martha.buendia@bswhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Sanchez, PhD
Organizational Affiliation
Baylor Scott and White Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor Scott and White Community Care
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha Buendia, Bach
Phone
214-865-2422
Email
martha.buendia@bswhealth.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
Two years
IPD Sharing Access Criteria
Contact Principal Investigators
Learn more about this trial
Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use- Electronic Spanish Platform
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