Alcohol Use Disorder (AUD)NCT06722690
eTSF for Latinx Young Adults With Alcohol Use Disorder
A study testing eTSF and Educational materials in people with Alcohol Use Disorder (AUD), run by Tulane University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- eTSF and Educational materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2027to Aug 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- eTSF, Educational materials
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eTSFBehavioural
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.
Educational materialsBehavioural
Educational materials on drinking problems and a list of local/online AA meetings.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: eTSF |
| Educational control | Active comparator | This arm will receive educational materials on drinking problems and a list of local/online AA meetings Receives: Behavioral: Educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility
Recruitment feasibility will be measured by the number of participants screened and enrolled each month.
Measured: 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.
Measured: From recruitment to baseline assessment up to two years
Retention/attrition feasibility
Retention/attrition feasibility will be measured by retention rates in each condition.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to the end of treatment at three months.
Secondary outcomes (2)
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.
Measured: 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.
Measured: From baseline to the end of treatment at three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study startAug 2027 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722690
- Sponsor's protocol ID
- 2024-779
- Other IDs
- K01AA031323
- Status last verified
- Oct 2026
- First submitted
- 26 Nov 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be shared on the NIAAA Data Archive.