Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04618653 |
| Other study ID # |
1525759-3 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 28, 2020 |
| Est. completion date |
September 20, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
University of New Mexico |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Alcoholics Anonymous (AA) is one of the most popular resources for dealing with
alcohol-related problems, and 12-step therapy (TS), based upon AA doctrine and practice, is
one of the prevailing alcohol treatment approaches in the United States. Two large multisite
trials, one high in internal validity and the second high in external validity came to the
same conclusion, TS was equally effective as more research supported therapies, and may
actually be superior when total abstinence is the treatment goal. A primary objective of TS
is to facilitate AA affiliation and strong evidence suggests that this aim is a major factor
accounting for the effectiveness of TS. High priority has therefore been assigned to the
investigation of what actually occurs in AA, with a special focus on identifying prescribed
AA behaviors and processes that are predictive of drinking reduction. The guiding assumption
of these efforts is that the key to improve TS is to first understand AA better. To this end,
this study will generate, for the first time, a comprehensive and definitive process model of
AA-related behavior change. This objective will be realized through the highly innovative use
of EMA data collection among early AA affiliates. Using real-time daily data, aim 1 will
determine if four MOBC identified by AA researchers (gains in social support, increased
abstinence self-efficacy, spiritual practices, and negative urgency) mediate the linkage
between three types of AA prescribed behaviors and drinking outcome. Noteworthy, these
analyses will include the first rigorous testing of six of seven of criteria to confirm (or
reject) that these four statistical mediators are MOBC. Aim 2 will investigate whether the
actions of the AA active ingredients on mediators (a path) and the actions of the mediators
(b path) are constant over time or, alternatively, if there are critical periods of
influence. Last, aim 3 will determine if the four MOBC operate differently across distinct
subpopulations. To achieve study aims, we propose a two-group randomized longitudinal study
(N = 190). In one group (n = 130) we will collect 6-months of continuous EMA data, allowing
us to examine near real-time associations between AA active ingredients in three domains,
four MOBC, and drinking. In tandem, we will also conduct in-person interviews at baseline, 3,
and 6-months. Assessment reactivity is a concern, especially so because this will be the
first study to use EMA in addition to in-person interviews in AA research. We will therefore
include a traditional fixed assessment group (n = 60) also interviewed at baseline, 3, and
6-months to identify potential measurement biases introduced in our innovative approach.
Achievement of study aims will generate the first empirically validated AA process model that
will inform TS with critical information for improving treatment outcomes.
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%).
