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Clinical Trials/NCT06722690
NCT06722690
Not yet recruiting
Not Applicable

Culturally Adapting Spiritually and Technologically Informed Interventions to Reduce Alcohol-Related Health Disparities Among Latinx Young Adults- Aim 3 RCT

Tulane University0 sites40 target enrollmentJanuary 2027

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alcohol Use Disorder (AUD)
Sponsor
Tulane University
Enrollment
40
Primary Endpoint
Recruitment feasibility
Status
Not yet recruiting
Last Updated
last year

Overview

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.
Registry
clinicaltrials.gov
Start Date
January 2027
End Date
February 2029
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Audrey Hai

Assistant Professor

Tulane University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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.)

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