Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Alcohol Use Disorder (AUD)
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Recruitment. Adults will be recruited at AA clubs and other AA meeting locations in Albuquerque, NM. We have previously recruited from these AA clubs and have a solid record of achieving our recruitment goals. We will recruit and consent 4 participants per month. Recruitment efforts will begin in mo...

Recruitment. Adults will be recruited at AA clubs and other AA meeting locations in Albuquerque, NM. We have previously recruited from these AA clubs and have a solid record of achieving our recruitment goals. We will recruit and consent 4 participants per month. Recruitment efforts will begin in month 3 (year 01) and will continue until month 49 (year 4). Recruitment will be unrestricted with regard to gender and minorities. We expect that racial/ethnic diversity will be consistent with our past AA studies with similar inclusion/exclusion criteria (54-65% male, 41-43% Hispanic. Based on considerable expertise, research staff will recruit participants from AA club lounge areas (which will result with the staff member providing a study advertisement flyer to the prospect) or directly through flyers posted in AA clubs (detailed background information provided). Interested prospects will first complete a stage 1 eligibility screen via a web-based application (link provided on flyer) or through a telephone interview with research staff (phone number provided on flyer). All inclusion/exclusion criteria will be collected in stage 1 screening with the exceptions of inclusion criterion #1 (ADS) and exclusion criterion #4 (active psychosis/in ability to provide documented informed consent). Prospects that are deemed eligible and who remain interested will have an appointment scheduled at CASAA for stage 2 screening. In addition to verifying stage1 screening information, in stage 2 our research staff will administrer the ADS and determine if the prospect is actively psychotic and capable (or not) to provide informed consent. Randomization/Consent. After stage two screening, eligible clients who remain interested will be told the following by research staff, "It looks like this study is a good fit for you. The study has two groups, one involves a little time each day for six-months and it requires three in-person interviews, one today, the second in three-months, and then a six-month interview. The second group requires less time and effort on your part and, as a result, does not offer as much compensation. This second group has only three interviews, one today, the second in three-months, and then a six-month interview. Assignment to one of these groups is entirely random. To help you decide if you want to participate in this study we can tell you that you have about a one in three chance of being assigned to the low-effort compensation group. Do you have any questions? If not, would you like to participate this study?" Eligible prospects willing to proceed will then be randomized using the urn procedure. Urn variables are: (1) total ADS score, (2) PDA (past 90 days), and (3) percent days of AA attendance (past 90 days). Using data from two prior AA studies with similar inclusion/exclusion criteria, we calculated the median for these three variables. Our high-low values for this study are: AA attendance (8 or fewer days = 1, 9 or more days = 2), ADS (0-47 = 1, 48 and higher = 2), and PDA (0 to .55 = 1 and .56 to 1.0 = 2). Once group assignment has been determined, the RA will initiate the consent process with the consent form that corresponds to the assigned group. Participants electing to provide consent will be administered a breathalyzer test prior to signing of informed consent (must have a blood alcohol level < .05 to be consented). A consented person who has not completed the baseline assessment after two weeks of consenting date will be regarded as inactive and their "slot" in the study will be filled with another person. We have discussed and developed this consenting procedure in collaboration with the UNM IRB staff In-Person Assessments. All study participants will be interviewed and complete self-report questionnaires at baseline, 3, and 6-months. These battery's (Table 2; Appendix A), have 3 semi-structured interviews and 9 self-report questionnaires. All assessments have strong psychometric properties and will be administered by trained project research staff in an office dedicated to research assessment. To reduce the influence of assessment order effects, self-report questionnaires will be rotated, and the order of self-report and semi-structured interviews will also be rotated across assessment points. Table 2. Proposed In-Person Assessment Battery Assessment Type of Assessment Intake 3-mo 6-mo Screening Form (stage 1 and 2) Structured Interview X Informed Consent Structured Interview X Locator Form Structured Interview X p.r.n. p.r.n. Demographic Interview Structured Interview X Alcohol Dependence Severity (ADS) Self-Report X Form 90 - (Healthcare/Substance Use) Structured Interview X X X Drinker Inventory of Consequences (DrInC) Self-Report X X X Twelve-Step Participation Questionnaire (TSPQ) Self-Report X X X Important People and Activities (IPA) Structured Interview X X X Group Environment Scale (GES) Self-Report X X X What I got From Treatment (WFT) Self-Report X X X General AA Tools of Recover (GAATOR) Self-Report X X X Religious Practices and Beliefs (RPB) Self-Report X X X Alcohol Abstinence Self-Efficacy Scale (AASE) Self-Report X X X UPPS Impulsive Behavior Scale Self-Report X X X D.8.b. Scheduling Follow-up Interviews. At the end of the baseline assessment, research staff will schedule a date for the 3-month follow-up interview with each participant (N = 190). At this time, locator and contact information will be reviewed for accuracy. About 2 weeks before the scheduled 3-month interview, we will initiate a reminder using phone and/or mail, as necessary. All participants will have access to public transportation fare, if needed. At the end of the 3-month interview research staff will schedule the 6-month interview, review contact information with the participant, and repeat the two-week reminder call. Regardless of whether or not a 3-month interview had been conducted every possible effort will be made to locate, schedule, and conduct the 6-month interview. All 3 and 6-month interviews will be conducted at CASAA. D.8.c. Follow-Up Procedures and Attrition. Our research staff specializes in follow-up tracking of clinical samples. Specifically, our staff is highly experienced in using state-of-the-art techniques in locating and scheduling clients for interviews, e.g., multiple locator information, postal system, MVD checks, reverse phone directories, house calls, internet credit searches, county, state, and national death registries. All our procedures are IRB approved, and are explained to prospective study participants before obtaining informed consent. We are confident that we can achieve an 80-85%% follow-up rate at the three and six-month follow-up. Explained, when we conducted a 10-year follow-up of the Project MATCH outpatient sample recruited in Albuquerque, seven years had elapsed without participant contact of any kind. Of the 181 surviving participants that consented for a long-term follow-up at the 3-year interview (22 had died) we successfully interviewed 148 (82%).

Tracking Information

NCT #
NCT04618653
Collaborators
Not Provided
Investigators
Principal Investigator: JEFFREY TONIGAN, phd UNIVERSITY OF NEW MEXICO (CASAA) Study Director: Matthew r Pearson, phd UNIVERSITY OF NEW MEXICO (CASAA)