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 University of Texas at Austin.
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
- May 2027to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 startMay 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.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Hang Hai, University of Texas at Austin
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
- 4 Nov 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapting Spiritually and Technologically Informed Interventions to Reduce Alcohol-Related Health Disparities Among Latinx Young Adults- Aim 3 RCT
- ClinicalTrials.gov ID
- NCT06722690
- Acronym / sponsor ID
- 2024-779
- Conditions
- Alcohol Use Disorder (AUD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- May 2027 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eTSF | Experimental | Behavioral: eTSFThis 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. |
| Educational control | Active comparator | Behavioral: Educational materialsThis arm will receive educational materials on drinking problems and a list of local/online AA meetings |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eTSFeTSF 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. | Behavioural | eTSF |
| Educational materialsEducational materials on drinking problems and a list of local/online AA meetings. | Behavioural | Educational control |
Primary outcome
Recruitment feasibility
Time frame: Every 4 weeks up to 2 years
Recruitment feasibility will be measured by the number of participants screened and enrolled each month.
Randomization feasibility
Time frame: From recruitment to baseline assessment up to two years
Randomization feasibility will be measured by the number of baseline demographic variables with statistically significant group differences.
Retention/attrition feasibility
Time frame: From recruitment to the end of the trial at three months.
Retention/attrition feasibility will be measured by retention rates in each condition.
Adherence feasibility
Time frame: From recruitment to the end of the trial at three months.
Adherence feasibility will be measured by the percentage of eTSF app components used by the eTSF condition participants.
Assessment feasibility
Time frame: From recruitment to the end of the trial at three months.
Assessment feasibility will be measured by the proportion of missing data in each assessment.
Intervention credibility
Time frame: From baseline to the end of treatment at three months.
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.
Intervention satisfaction
Time frame: From baseline to the end of treatment at three months.
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.
Intervention acceptability
Time frame: From baseline to the end of treatment at three months.
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.
Intervention engagement
Time frame: From baseline to the end of treatment at three months.
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.
2 secondary outcomes
Alcohol use
Time frame: From baseline to the end of treatment at three months.
12-Step fellowship engagement
Time frame: From baseline to the end of treatment at three months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. The IPD will be shared on the NIAAA Data Archive.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing eTSF and Educational materials in people with Alcohol Use Disorder (AUD), run by University of Texas at Austin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hang Hai (504-247-1457, ahai@tulane.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility (time frame: Every 4 weeks up to 2 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.