Alcohol Use Disorder (AUD)
Conditions
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.
Interventions
BEHAVIORALeTSF
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.
BEHAVIORALEducational materials
Educational materials on drinking problems and a list of local/online AA meetings.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Tulane University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention engagement | 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. |
| Adherence feasibility | 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 | 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 | 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 | 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 | 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. |
| Recruitment feasibility | Every 4 weeks up to 2 years | Recruitment feasibility will be measured by the number of participants screened and enrolled each month. |
| Randomization feasibility | 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 | From recruitment to the end of the trial at three months. | Retention/attrition feasibility will be measured by retention rates in each condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol use | From baseline to the end of treatment at three months. | 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. |
| 12-Step fellowship engagement | From baseline to the end of treatment at three months. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Drug use | From baseline to the end of treatment at three months. | Drug use will be measured with the aforementioned TLFB-Form 90 |
| Psychological distress | From baseline to the end of treatment at three months. | 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. |
| Drinking consequences | From baseline to the end of treatment at three months. | 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. |
Contacts
Primary ContactHang Hai
Outcome results
None listed