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Active Not RecruitingNCT04776278

Behavioral Economic and Wellness-based Approaches for Reducing Alcohol Use and Consequences Among Emerging Adults

Behavioral Economic and Wellness-based Approaches for Reducing Alcohol Use and Consequences Among Diverse Non-student Emerging Adults

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
525 (estimated)
Sponsor
University of Memphis · Academic / Other
Sex
All
Age
18 Years – 29 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate an intervention approach for non-student emerging adults that attempts to reduce alcohol use by decreasing stress and increasing engagement in positive and goal-directed activities that provide meaningful alternatives to alcohol use.

Detailed description

Brief alcohol interventions (BAI) are among the most cost-effective preventive care measures available and the evaluation of these interventions with high-risk and difficult-to-reach populations is an NIAAA priority. Although emerging adults (EAs) who attend college often have access to brief alcohol interventions (BAIs), there is a critical need to enhance both the efficacy and potential for dissemination of these approaches with high-risk non-student EAs. EAs who are not 4-year college students or graduates report higher levels of alcohol-related problems, greater levels of comorbid drug use and mental health symptoms, and higher risk for chronic alcohol use disorder compared to college graduates. Most BAIs include a single session focused explicitly on discussing risks associated with drinking and correcting normative beliefs about drinking rates without addressing the reasons why EAs may drink, including stress and limited behavioral alternatives to drinking. Because many EAs who do not graduate from college are socially and economically marginalized, an approach that encourages them to drink less without providing the tools to reduce stress and develop mood enhancing behavioral substitutes to drinking or drug use is unlikely to be successful. The Substance-Free Activity Session (SFAS) attempts to increase engagement goal-directed activities that might provide alternatives to alcohol use and also includes strategies for coping with stress/depression. The two-session (plus booster) BAI+SFAS approach has demonstrated efficacy for reducing both alcohol use/problems and depressive symptoms in two randomized clinical trials with college EAs and may be a more promising approach than single-session BAIs for higher-risk non-student EAs. Two critical next steps are to: 1) evaluate the BAI+SFAS with non-student EAs, and 2) determine if a two-session Relaxation Training (RT) +SFAS approach, which would enhance wellness and address two synergistic risk factors for alcohol misuse, demonstrates similar efficacy as the BAI+SFAS intervention. If so, this wellness-based approach may have greater potential for dissemination than approaches that include a BAI because the session content may be more appealing to EAs (managing stress and increasing positive activities). Thus, the primary goal of the proposed study is to establish the efficacy of these novel BAI approaches with high-risk community dwelling EAs, and a secondary goal is to identify factors that may increase potential for dissemination. We will conduct a randomized 3-group (BAI+SFAS vs. RT+SFAS vs. education control) trial with 525 EAs (175 per group; estimated 50% women \& 50% African American) who report recent heavy drinking and who are not students or graduates of 4-year colleges. Outcomes will be assessed at 1, 3, 6, and 12 months post-intervention.

Conditions

Interventions

TypeNameDescription
BEHAVIORALBrief Alcohol Intervention (BAI)This session includes a discussion related to harm reduction and the participant's autonomy to make decisions about the information provided in the session; an alcohol use decisional balance exercise; personalized alcohol-related feedback, and goal-setting. Elements included in the feedback are: (a) comparison of the participant's perception of how much he or she drinks and actual norms, (b) a comparison of the participant's alcohol consumption vs. norms, (c) an estimate of the participant's peak blood alcohol content in the past month, (d) alcohol-related problems experienced, (e) money spent on alcohol, and (f) calories consumed from alcohol. Participants discuss the personalized feedback with the clinician and review protective behavioral strategies if he or she indicates interest.
BEHAVIORALSubstance-free Activity Session (SFAS)The SFAS session includes : a) discussion of life goals, b) discussion of associations between alcohol and drug use, goals, and substance-free activities; c) a graph depicting the participant's ratings of the relative importance of various aspects of their life and how their actions in the past week have been consistent with these priorities; d) personalized feedback on recent time allocation to activities across life domains, and a discussion of any changes the participant would like to make; e) feedback on symptoms of stress, anxiety and discussion of adaptive coping strategies; f) discussion of enjoyable substance-free activities and hobbies and substance-free recreational activity suggestions tailored to individual's interests and neighborhood; g) a goal setting exercise for specific behavior change plans; h) a Future Thinking Writing Exercise. Participants will receive weekly text-message based booster prompts for four weeks after their SFAS session.
BEHAVIORALRelaxation Training (RT)The clinician will begin by establishing the credibility of the session by providing the participant with the rationale that developing relaxation or mindfulness training strategies can reduce stress and enhance wellness. The clinician will then lead the participant through a diaphragmatic breathing exercise, followed by a progressive muscle RT protocol, and then a brief breath-counting (mindfulness) exercise. The session will conclude with a brief discussion of additional stress and anxiety management strategies (e.g., apps to monitor heartrate and breathing). Participants will be asked about their reaction to the techniques and, if interested, encouraged to commit to a specific plan for practicing these techniques.
OTHEREducation ControlThis condition will not include any clinical contact other than a brief (2-3 minute) discussion with the research assistant (RA) who completed the assessment session and who will describe the educational handout. This condition is meant to approximate a low-threshold public health-level approach to providing referral information and some of the content included in the BAI+SFAS condition but without any of the personalized information or MI/clinical contact. Thus, participants will receive information on risks associated with alcohol and drug misuse, strategies for reducing use/problems, and strategies for managing stress and setting and follow-through with achievable goals. The handout will also include links to hotlines, websites, and apps related to these domains. This condition will not include booster contact.

Timeline

Start date
2022-01-17
Primary completion
2026-05-01
Completion
2026-05-01
First posted
2021-03-01
Last updated
2025-09-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04776278. Inclusion in this directory is not an endorsement.