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| ID | Type | Description | Link |
|---|---|---|---|
| K01AA031323 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Educational control | Active Comparator | This arm will receive educational materials on drinking problems and a list of local/online AA meetings |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hang Hai | Contact | 504-247-1457 | ahai@tulane.edu |
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The IPD will be shared on the NIAAA Data Archive.
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Educational materials | Behavioral | Educational materials on drinking problems and a list of local/online AA meetings. |
|
| 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. |
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. |
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. |