Clinical trial NCT04776278: Behavioral Economic and Wellness-based Approaches for Reducing Alcohol Use and Consequences Among Emerging Adults
Official title: Behavioral Economic and Wellness-based Approaches for Reducing Alcohol Use and Consequences Among Diverse Non-student Emerging Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Abuse
Keywords: Alcohol
Brief Intervention
Lead sponsor: University of Memphis
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 18 to 29 years old
* Not a current student or graduate of a 4-year college with no plans to enroll in a 4-year college in the upcoming semester
* Stable domicile and contact information
* Fluent English speaker
* Adequate literacy (\>9th grade reading ability)
* Two or more heavy episodic drinking episodes in the past month (\>5/4 standard drinks for males/ females) or exceeding NIAAA guidelines for high risk drinking (\>14/7 drinks per week for men/women).

Exclusion Criteria:

* Current/past psychosis
* Current self-initiated AUD/SUD treatment
* Weekly or greater nonmedical use of prescription drugs or illegal drugs except cannabis
* Risk for alcohol withdrawal as evidenced by either 1) a recent history of alcohol withdrawal symptoms (tremors, anxiety, hallucinations, and seizures that occur after stopping drinking) or 2) very heavy weekly drinking reports on the alcohol screener (\> 40 standard drinks in a typical week in the past month, a value that is \> 2 standard deviations above the average drinks per week level observed in our previous brief alcohol intervention studies).

Primary outcomes:
measure: Change from Baseline Alcohol Consumption and Drug Use at 1-month
timeFrame: Enrollment, 1-month post intervention
measure: Change from Baseline Alcohol Consumption and Drug Use at 3-months
timeFrame: Enrollment, 3-months post intervention
measure: Change from Baseline Alcohol Consumption and Drug Use at 6-months
timeFrame: Enrollment, 6-months post-intervention
measure: Change from Baseline Alcohol Consumption and Drug Use at 12-months
timeFrame: Enrollment, 12-months post intervention
measure: Change from Baseline Alcohol-related Consequences at 1-month
timeFrame: Enrollment, 1-month
measure: Change from Baseline Alcohol-related Consequences at 3-months
timeFrame: Enrollment, 3-months
measure: Change from Baseline Alcohol-related Consequences at 6-months
timeFrame: Enrollment, 6-months
measure: Change from Baseline Alcohol-related Consequences at 12-months
timeFrame: Enrollment, 12-months
Secondary outcomes:
measure: Change from Baseline Substance-free and Substance-related Activity Participation at 1-month
timeFrame: Enrollment, 1-month post intervention
measure: Change from Baseline Substance-free and Substance-related Activity Participation at 3-months
timeFrame: Enrollment, 3-months post intervention
measure: Change from Baseline Substance-free and Substance-related Activity Participation at 6-months
timeFrame: Enrollment, 6-months post intervention
measure: Change from Baseline Substance-free and Substance-related Activity Participation at 12-months
timeFrame: Enrollment, 12-months post intervention
measure: Change from Baseline Alcohol Purchase Task responses at 1-month
timeFrame: Enrollment, 1-month post intervention
measure: Change from Baseline Alcohol Purchase Task responses at 3-months
timeFrame: Enrollment, 3-months post intervention
measure: Change from Baseline Alcohol Purchase Task responses at 6-months
timeFrame: Enrollment, 6-months post intervention
measure: Change from Baseline Alcohol Purchase Task responses at 12-months
timeFrame: Enrollment, 12-months post intervention
measure: Change from Baseline in the Depression, Anxiety, and Stress Scales (DASS) at 1-month
timeFrame: Enrollment, 1-month post intervention
measure: Change from Baseline in the Depression, Anxiety, and Stress Scales (DASS) at 3-month
timeFrame: Enrollment, 3-months post intervention
measure: Change from Baseline in the Depression, Anxiety, and Stress Scales (DASS) at 6-months
timeFrame: Enrollment, 6-months post intervention
measure: Anxiety, and Stress Scales (DASS) at 12-months
timeFrame: Enrollment, 12-months post intervention
measure: Change from Baseline in the Short Self-Regulation Questionnaire (SSRQ) at 1-month
timeFrame: Enrollment, 1-month post intervention
measure: Change from Baseline in the Short Self-Regulation Questionnaire (SSRQ) at 3-months
timeFrame: Enrollment, 3-months post intervention
measure: Change from Baseline in the Short Self-Regulation Questionnaire (SSRQ) at 6-months
timeFrame: Enrollment, 6-months post intervention
measure: Change from Baseline in the Short Self-Regulation Questionnaire (SSRQ) at 12-months
timeFrame: Enrollment, 12-months post intervention
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Memphis
state: Tennessee
Study officials:
References: