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

NCT05476588 | Completed

• 1 other identifier: 022-114
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use; Alcohol Abuse; Prescription Drug Abuse; Substance Use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• CAGE (Cut Down, Annoyed, Guilty, Eye-Opener) for concurrent and convergent validity of the TAPS

  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

Study Arms (2)

Self-Administration followed by Interviewer-Administered

ACTIVE COMPARATOR

Screening and validation of assessment tool translated into Spanish

Other: Screening

Interviewer-Administered followed by Self-Administration

ACTIVE COMPARATOR

Screening and validation of assessment tool translated into Spanish

Other: Screening

Interventions

Screening OTHER

Screening and validation of assessment tool translated into Spanish

Interviewer-Administered followed by Self-Administration; Self-Administration followed by Interviewer-Administered

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Current patient of the clinic
• Spanish-language preferred
• Ability to read Spanish

You may not qualify if:

• Unable to provide informed consent
• Inability to comprehend or read Spanish
• Inability to self-administer the iPad tool due to physical limitations

Sponsors & Collaborators

• Baylor Research Institute: lead
• COG Analytics: collaborator

Study Sites (1)

Baylor Scott and White Community Care

Dallas, Texas, 75246, United States

Location

Related Publications (1)

• Gryczynski J, Sanchez K, Carswell SB, Schwartz RP. The Spanish language version of the TAPS tool: protocol for a validation and implementation study in primary care. Addict Sci Clin Pract. 2023 Nov 16;18(1):69. doi: 10.1186/s13722-023-00423-9.

  PMID: 37974265 DERIVED

MeSH Terms

Conditions

Tobacco Use; Alcoholism; Substance-Related Disorders

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Behavior; Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Katherine Sanchez, PhD

  Baylor Scott and White Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, two-group design.

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 27, 2022
• Study Start: July 15, 2022
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: January 26, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Two years
• Access Criteria: Contact Principal Investigators

Locations

US (1)