ETSF for Latinx Young Adults with Alcohol Use Disorder

Culturally Adapting Spiritually and Technologically Informed Interventions to Reduce Alcohol-Related Health Disparities Among Latinx Young Adults- Aim 3 RCT

The goal of this clinical trial is to learn if the eTSF intervention is feasible among Latinx young adults with alcohol use disorder. The main questions it aims to answer are:

• Is eTSF feasible?
• Is eTSF effective in reducing alcohol use and increasing 12-step engagement compared to the control condition? The control condition will receive educational materials on drinking problems and a list of local/online AA meetings Participants will
• Be randomly assigned to either the eTSF condition or the control condition.
• Fill out the baseline online survey.
• Go through the eTSF app/control materials.
• And at 3 months post-baseline, fill out the follow-up online survey.

Study Overview

• Status: Not yet recruiting
• Conditions: Alcohol Use Disorder (AUD)
• Intervention / Treatment: Behavioral: eTSF; Behavioral: Educational materials

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hang Hai; Phone Number: 504-247-1457; Email: ahai@tulane.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• YAs age 18-29
• Identify as Latinx
• Meet the Diagnostic & Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnostic criteria for alcohol use disorder
• Are at least minimally motivated to change their drinking (i.e., scoring ≥3 on the University of Rhode Island Change Assessment Scale's contemplation, action, or maintenance subscales and ≤3 on the precontemplation subscale)
• Be able to provide at least one contact person to assist in tracking them for follow-up assessment

Exclusion Criteria:

• Attending any 12-step program (≥2 meetings in the past month)
• Experiencing psychotic symptoms or cognitive impairment
• In alcohol or drug treatment programs
• Taking addiction treatment medications
• Experiencing, expecting to experience, or had a history of severe/complicated withdrawal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eTSF; This arm will receive the eTSF intervention. eTSF is a smartphone app intervention featuring culturally relevant content aimed at supporting Latinx young adults with alcohol use disorder in participating in 12-step groups.	Behavioral: eTSF; eTSF is a smartphone app intervention featuring culturally relevant content aimed at supporting Latinx young adults with alcohol use disorder in participating in 12-step groups.
Active Comparator: Educational control; This arm will receive educational materials on drinking problems and a list of local/online AA meetings	Behavioral: Educational materials; Educational materials on drinking problems and a list of local/online AA meetings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment feasibility	Recruitment feasibility will be measured by the number of participants screened and enrolled each month.	Every 4 weeks up to 2 years
Randomization feasibility	Randomization feasibility will be measured by the number of baseline demographic variables with statistically significant group differences.	From recruitment to baseline assessment up to two years
Retention/attrition feasibility	Retention/attrition feasibility will be measured by retention rates in each condition.	From recruitment to the end of the trial at three months.
Adherence feasibility	Adherence feasibility will be measured by the percentage of eTSF app components used by the eTSF condition participants.	From recruitment to the end of the trial at three months.
Assessment feasibility	Assessment feasibility will be measured by the proportion of missing data in each assessment.	From recruitment to the end of the trial at three months.
Intervention credibility	Intervention credibility will be measured using a single-item question: "On a scale from 1 to 5, where 1 indicates 'not at all' and 5 indicates 'very much,' to what extent do you believe this treatment will be beneficial for you?" Only eTSF condition participants will receive this measure.	From baseline to the end of treatment at three months.
Intervention satisfaction	Intervention satisfaction will be measured using the mHealth Satisfaction Questionnaire, which has a total score range from 14 to 42. Higher total scores indicate greater user satisfaction with the mHealth app.	From baseline to the end of treatment at three months.
Intervention acceptability	Acceptability will be measured using the Abbreviated Acceptability Rating Profile, which scores range from 8 to 48. Higher scores indicate greater acceptability of the intervention.	From baseline to the end of treatment at three months.
Intervention engagement	Intervention engagement will be automatically recorded by the app during the study period and be measured in terms of app opening frequency, time spent on the app per use session (i.e., the time between opening and closing the app), most frequently used intervention component, time spent per intervention component, the completion rate of each selected component, reports of technical problems.	From baseline to the end of treatment at three months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol use	Alcohol use will be measured using the Time-Line Follow-Back (TLFB) method-Form 90, which helps participants recall and mark days on which they used alcohol during the past 90 days.	From baseline to the end of treatment at three months.
12-Step fellowship engagement	12-Step fellowship engagement will be measured with the Multi-Dimensional Mutual-help Activity Scale (MDMAS), which measures seven dimensions of experience (meeting attendance, meeting participation, fellowship involvement, step work, mandated attendance, affiliation, and safety). Total score ranges from 32-160 with higher scores within indicating greater engagement.	From baseline to the end of treatment at three months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drinking consequences	Drinking consequences will be measured with the Short Inventory of Problems (SIP-2R). Score ranges from 0-45 with higher scores indicating a greater frequency of experiencing problems related to substance use.	From baseline to the end of treatment at three months.
Drug use	Drug use will be measured with the aforementioned TLFB-Form 90	From baseline to the end of treatment at three months.
Psychological distress	Psychological distress will be assessed with the 18-item Brief Symptom Inventory. Score ranges 0-72 and higher scores indicate greater levels of psychological distress.	From baseline to the end of treatment at three months.

Collaborators and Investigators

• Sponsor: Tulane University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Alcoholism; Alcohol Drinking
• Other Study ID Numbers: 2024-779; K01AA031323 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD will be shared on the NIAAA Data Archive.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No