ETSF for Latinx Young Adults with Alcohol Use Disorder

NCT06722690 | Not Yet Recruiting

• 2 other identifiers: 2024-779K01AA031323
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alcohol Use Disorder (AUD)

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (2)

• Alcohol use

  From baseline to the end of treatment at three months.

• 12-Step fellowship engagement

  From baseline to the end of treatment at three months.

Other Outcomes (3)

• Drinking consequences

  From baseline to the end of treatment at three months.

• Drug use

  From baseline to the end of treatment at three months.

• Psychological distress

  From baseline to the end of treatment at three months.

Study Arms (2)

eTSF

EXPERIMENTAL

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

Educational control

ACTIVE COMPARATOR

This arm will receive educational materials on drinking problems and a list of local/online AA meetings

Behavioral: Educational materials

Interventions

eTSF BEHAVIORAL

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.

eTSF

Educational materials BEHAVIORAL

Educational materials on drinking problems and a list of local/online AA meetings.

Educational control

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tulane University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hang Hai

CONTACT

504-247-1457; ahai@tulane.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 9, 2024
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share