- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04618653
Comprehensive Process Model of AA-related Behavior Change
Development of a Comprehensive and Dynamic AA Process Model: One Day at a Time
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 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%).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: JEFFREY TONIGAN, phd
- Phone Number: 5056100932
- Email: jtonigan@unm.edu
Study Contact Backup
- Name: Matthew r pearson, phd
- Phone Number: 7572921799
- Email: mateo.pearson@gmail.com
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87106
- Center on Alcohol, Substance Use, and Addictions (CASAA)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- ADS score ≥ 8 (past 12 months)
- alcohol use, past 4 months
- attended ≥ 1 AA meeting, past three months
- ≥ 18 years of age
- speak and read English at the sixth grade level.
Exclusion Criteria:
- ≥ 4 months of continuous AA attendance (lifetime), with continuous defined as attending at least 1 AA meeting per week over a 4-month period
- admitted into inpatient or outpatient substance abuse treatment in the prior 12 months (currently seeking treatment will not be a basis to exclude)
- unable to provide the names of two locators
- active psychosis or a condition impairing ability to provide informed consent
- pending legal convictions involving ≥ 90-days incarceration
- plans to relocate to another state
- ≥ 3 formal treatment experiences (lifetime) for substance abuse
- ≥ 12 months of continuous abstinence from alcohol (lifetime) initiated in response to perceived alcohol-related problems.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Early AA Attenders with Alcohol Use Disorder
observational study that includes three fixed assessments (Baseline, 3, and 6-month).
Subset of participants will also provide daily EMA data.
|
Three assessment will include computerized assessments, interviews, and subset will provide daily reports of prescribed AA behaviors and practices
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Percent abstinent days at baseline, 3 months and six-months
Time Frame: baseline, 3, and 6, months
|
calculated as the number of abstinent days in an assessment window divided by the total number of days in an assessment window
|
baseline, 3, and 6, months
|
Change in daily Percent abstinent days baseline to six-months
Time Frame: baseline to six-months
|
mobile device will provide daily reported drinking
|
baseline to six-months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: JEFFREY TONIGAN, phd, UNIVERSITY OF NEW MEXICO (CASAA)
- Study Director: Matthew r Pearson, phd, UNIVERSITY OF NEW MEXICO (CASAA)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1525759-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Use Disorder (AUD)
-
Washington State UniversityRecruitingNicotine Use Disorder | Alcohol Use Disorder (AUD)United States
-
Centre Hospitalier Universitaire de NīmesRecruiting
-
Central Institute of Mental Health, MannheimNot yet recruitingAlcohol Use Disorder (AUD)Germany
-
Massachusetts General HospitalMbarara University of Science and TechnologyCompletedAlcohol Use Disorder (AUD)Uganda
-
Woebot HealthStanford UniversityCompletedSubstance Use Disorders | Alcohol Use Disorder (AUD)United States
-
Kaiser PermanenteNORC at the University of Chicago; Agency for Healthcare Research and Quality... and other collaboratorsCompleted
-
VA Office of Research and DevelopmentNot yet recruitingAlcohol Use Disorder (AUD)United States
-
University of SydneyMonash UniversityRecruitingAlcohol Use Disorder (AUD)Australia
-
Washington State UniversityRecruitingAlcohol Use Disorder (AUD)United States
-
SRI InternationalNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingAlcohol Use Disorder (AUD)United States
Clinical Trials on assessment only
-
Northwell HealthCornell University; Sage BionetworksCompletedImpulsive Behavior | Self-RegulationUnited States
-
Vanderbilt University Medical CenterNational Institute of Mental Health (NIMH)RecruitingAutism Spectrum DisorderUnited States
-
Network for Perioperative Critical CareDebre Berhan UniversityCompleted
-
University of OklahomaCompletedSymptom Management | Reduce Treatment Non-adherenceUnited States
-
VA Office of Research and DevelopmentCompleted
-
Truth InitiativeCompleted
-
Boston Medical CenterUniversity of Rhode IslandCompleted
-
Johns Hopkins UniversityRakai Health Sciences ProgramCompletedEcological Momentary Assessment and Intervention
-
Luzerner KantonsspitalRecruiting
-
University of LeipzigGerman Society of Neurocritical CareRecruitingSubarachnoid Hemorrhage | Intracerebral HemorrhageGermany