Behavioral Economic and Wellness-based Approaches for Reducing Alcohol Use and Consequences Among Emerging Adults
- Conditions
- Alcohol Abuse
- Interventions
- Behavioral: Brief Alcohol Intervention (BAI)Other: Education ControlBehavioral: Substance-free Activity Session (SFAS)Behavioral: Relaxation Training (RT)
- Registration Number
- NCT04776278
- Lead Sponsor
- University of Memphis
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 525
- 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).
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brief Alcohol Intervention (BAI) + Substance Free Activity Session (SFAS) Substance-free Activity Session (SFAS) Participants first receive a 50-minute standard brief motivational intervention designed to reduce alcohol use. A week later, they will receive the Substance-free activity session (SFAS), a 50-minute counseling session designed to increase the salience of the individual's goals, to highlight the connection between their current patterns of behavior (including drinking and substance-free activities) and the attainment of these goals, and to increase future orientation and engagement in enjoyable and goal-directed activities that are inconsistent with substance use (even if the participant has no desire to change their use). Brief Alcohol Intervention (BAI) + Substance Free Activity Session (SFAS) Brief Alcohol Intervention (BAI) Participants first receive a 50-minute standard brief motivational intervention designed to reduce alcohol use. A week later, they will receive the Substance-free activity session (SFAS), a 50-minute counseling session designed to increase the salience of the individual's goals, to highlight the connection between their current patterns of behavior (including drinking and substance-free activities) and the attainment of these goals, and to increase future orientation and engagement in enjoyable and goal-directed activities that are inconsistent with substance use (even if the participant has no desire to change their use). Relaxation Training (RT) + Substance Free Activity Session (SFAS) Relaxation Training (RT) Participants will complete a relaxation training session that will include a clinician leading them through a diaphragmatic breathing exercise, a progressive muscle relaxation protocol, and then a brief breath-counting (mindfulness) exercise. A week later, the participant will receive the SFAS, a 50-minute counseling session designed to increase the salience of the individual's goals, to highlight the connection between their current patterns of behavior (including drinking and substance-free activities) and the attainment of these goals, and to increase future orientation and engagement in enjoyable and goal-directed activities that are inconsistent with substance use (even if the participant has no desire to change their use). Relaxation Training (RT) + Substance Free Activity Session (SFAS) Substance-free Activity Session (SFAS) Participants will complete a relaxation training session that will include a clinician leading them through a diaphragmatic breathing exercise, a progressive muscle relaxation protocol, and then a brief breath-counting (mindfulness) exercise. A week later, the participant will receive the SFAS, a 50-minute counseling session designed to increase the salience of the individual's goals, to highlight the connection between their current patterns of behavior (including drinking and substance-free activities) and the attainment of these goals, and to increase future orientation and engagement in enjoyable and goal-directed activities that are inconsistent with substance use (even if the participant has no desire to change their use). Education Control Education Control This minimal contact control condition will include a brief (2-3 minute) discussion where the research assistant (RA) who completed the assessment session will describe the educational handout. This condition is meant to approximate a 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 motivational interviewing. Participants will receive information on risks associated with alcohol/drug misuse, strategies for reducing alcohol problems, managing stress, and goal-setting. The handout will also include links to hotlines, websites, and apps related to these domains. This condition will not include booster contact
- Primary Outcome Measures
Name Time Method Change from Baseline Alcohol Consumption and Drug Use at 1-month Enrollment, 1-month post intervention At each assessment point, participants will complete a computer administered Daily Drinking Questionnaire (DDQ) concerning their daily drinking during a typical week in the past month, an interval found sufficiently long to characterize drinking patterns.
Change from Baseline Alcohol Consumption and Drug Use at 6-months Enrollment, 6-months post-intervention At each assessment point, participants will complete a computer administered Daily Drinking Questionnaire (DDQ) concerning their daily drinking during a typical week in the past month, an interval found sufficiently long to characterize drinking patterns.
Change from Baseline Alcohol Consumption and Drug Use at 3-months Enrollment, 3-months post intervention At each assessment point, participants will complete a computer administered Daily Drinking Questionnaire (DDQ) concerning their daily drinking during a typical week in the past month, an interval found sufficiently long to characterize drinking patterns.
Change from Baseline Alcohol Consumption and Drug Use at 12-months Enrollment, 12-months post intervention At each assessment point, participants will complete a computer administered Daily Drinking Questionnaire (DDQ) concerning their daily drinking during a typical week in the past month, an interval found sufficiently long to characterize drinking patterns.
Change from Baseline Alcohol-related Consequences at 6-months Enrollment, 6-months The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) questionnaire asks about negative events over the past month (e.g., neglected obligations, driving after drinking). Research has shown that the BYAACQ is reliable yet sensitive to changes in alcohol use, has high internal consistency, and includes common but less severe consequences.
Change from Baseline Alcohol-related Consequences at 1-month Enrollment, 1-month The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) questionnaire asks about negative events over the past month (e.g., neglected obligations, driving after drinking). Research has shown that the BYAACQ is reliable yet sensitive to changes in alcohol use, has high internal consistency, and includes common but less severe consequences.
Change from Baseline Alcohol-related Consequences at 3-months Enrollment, 3-months The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) questionnaire asks about negative events over the past month (e.g., neglected obligations, driving after drinking). Research has shown that the BYAACQ is reliable yet sensitive to changes in alcohol use, has high internal consistency, and includes common but less severe consequences.
Change from Baseline Alcohol-related Consequences at 12-months Enrollment, 12-months The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) questionnaire asks about negative events over the past month (e.g., neglected obligations, driving after drinking). Research has shown that the BYAACQ is reliable yet sensitive to changes in alcohol use, has high internal consistency, and includes common but less severe consequences.
- Secondary Outcome Measures
Name Time Method Change from Baseline Substance-free and Substance-related Activity Participation at 3-months Enrollment, 3-months post intervention Participants report past month frequency and rate the enjoyment of 16 activities that are substance free vs. substance involved. Frequency and enjoyment ratings are multiplied to obtain a cross product that reflects reinforcement derived from the activity, and the relative reinforcement value of alcohol (R-ratio) is computed for analysis \[(alcohol-related total / (alcohol-free total + alcohol-related total)\]. Participants also report the number of hours spent engaging in several activity categories during a typical week in the past month (work, exercise, drinking, recreation). This information is used to generate the initial SFAS feedback on time allocation and potential alternatives to drinking and, at follow-up, will evaluate whether the interventions resulted in increased participation in substance-free activities, increased substance-free reinforcement, and decreased proportionate substance-related reinforcement relative to the control condition (R-ratio).
Change from Baseline Substance-free and Substance-related Activity Participation at 12-months Enrollment, 12-months post intervention Participants report past month frequency and rate the enjoyment of 16 activities that are substance free vs. substance involved. Frequency and enjoyment ratings are multiplied to obtain a cross product that reflects reinforcement derived from the activity, and the relative reinforcement value of alcohol (R-ratio) is computed for analysis \[(alcohol-related total / (alcohol-free total + alcohol-related total)\]. Participants also report the number of hours spent engaging in several activity categories during a typical week in the past month (work, exercise, drinking, recreation). This information is used to generate the initial SFAS feedback on time allocation and potential alternatives to drinking and, at follow-up, will evaluate whether the interventions resulted in increased participation in substance-free activities, increased substance-free reinforcement, and decreased proportionate substance-related reinforcement relative to the control condition (R-ratio).
Change from Baseline Alcohol Purchase Task responses at 1-month Enrollment, 1-month post intervention This questionnaire asks participants to report how many standard drinks they would consume across 20 prices ($0 to $20) in an imaginary drinking setting, which yields multiple observed and derived indices reflecting sensitivity to price changes that correspond with actual alcohol use. Elasticity of demand and intensity (consumption at $0) will be used for analysis. Relative insensitivity to price changes ("inelastic" demand) is related to risky drinking and alcohol problems, and intensity has incremental utility to predict alcohol use disorder symptoms beyond drinking practices. Consistent with previous research, alcohol demand will be evaluated as a mediator of treatment outcomes.
Change from Baseline Substance-free and Substance-related Activity Participation at 6-months Enrollment, 6-months post intervention Participants report past month frequency and rate the enjoyment of 36 activities that are substance free vs. substance involved. Frequency and enjoyment ratings are multiplied to obtain a cross product that reflects reinforcement derived from the activity, and the relative reinforcement value of alcohol (R-ratio) is computed for analysis \[(alcohol-related total / (alcohol-free total + alcohol-related total)\]. Participants also report the number of hours spent engaging in several activity categories during a typical week in the past month (work, exercise, drinking, recreation). This information is used to generate the initial SFAS feedback on time allocation and potential alternatives to drinking and, at follow-up, will evaluate whether the interventions resulted in increased participation in substance-free activities, increased substance-free reinforcement, and decreased proportionate substance-related reinforcement relative to the control condition (R-ratio).
Change from Baseline Substance-free and Substance-related Activity Participation at 1-month Enrollment, 1-month post intervention Participants report past month frequency and rate the enjoyment of 16 activities that are substance free vs. substance involved. Frequency and enjoyment ratings are multiplied to obtain a cross product that reflects reinforcement derived from the activity, and the relative reinforcement value of alcohol (R-ratio) is computed for analysis \[(alcohol-related total / (alcohol-free total + alcohol-related total)\]. Participants also report the number of hours spent engaging in several activity categories during a typical week in the past month (work, exercise, drinking, recreation). This information is used to generate the initial SFAS feedback on time allocation and potential alternatives to drinking and, at follow-up, will evaluate whether the interventions resulted in increased participation in substance-free activities, increased substance-free reinforcement, and decreased proportionate substance-related reinforcement relative to the control condition (R-ratio).
Change from Baseline Alcohol Purchase Task responses at 3-months Enrollment, 3-months post intervention This questionnaire asks participants to report how many standard drinks they would consume across 20 prices ($0 to $20) in an imaginary drinking setting, which yields multiple observed and derived indices reflecting sensitivity to price changes that correspond with actual alcohol use. Elasticity of demand and intensity (consumption at $0) will be used for analysis. Relative insensitivity to price changes ("inelastic" demand) is related to risky drinking and alcohol problems, and intensity has incremental utility to predict alcohol use disorder symptoms beyond drinking practices. Consistent with previous research, alcohol demand will be evaluated as a mediator of treatment outcomes.
Change from Baseline Alcohol Purchase Task responses at 6-months Enrollment, 6-months post intervention This questionnaire asks participants to report how many standard drinks they would consume across 20 prices ($0 to $20) in an imaginary drinking setting, which yields multiple observed and derived indices reflecting sensitivity to price changes that correspond with actual alcohol use. Elasticity of demand and intensity (consumption at $0) will be used for analysis. Relative insensitivity to price changes ("inelastic" demand) is related to risky drinking and alcohol problems, and intensity has incremental utility to predict alcohol use disorder symptoms beyond drinking practices. Consistent with previous research, alcohol demand will be evaluated as a mediator of treatment outcomes.
Change from Baseline Alcohol Purchase Task responses at 12-months Enrollment, 12-months post intervention This questionnaire asks participants to report how many standard drinks they would consume across 20 prices ($0 to $20) in an imaginary drinking setting, which yields multiple observed and derived indices reflecting sensitivity to price changes that correspond with actual alcohol use. Elasticity of demand and intensity (consumption at $0) will be used for analysis. Relative insensitivity to price changes ("inelastic" demand) is related to risky drinking and alcohol problems, and intensity has incremental utility to predict alcohol use disorder symptoms beyond drinking practices. Consistent with previous research, alcohol demand will be evaluated as a mediator of treatment outcomes.
Change from Baseline in the Depression, Anxiety, and Stress Scales (DASS) at 1-month Enrollment, 1-month post intervention The DASS is a reliable and valid self-report survey designed to measure symptoms of depression, anxiety and stress. Each of the three DASS scales contains seven items and participants are asked to use 4-point scales to rate the extent to which they have experienced each emotional state over the past week; scores for depression, anxiety and stress are calculated by summing the scores. For the purpose of this study, we will only include the depression and anxiety subscale items. Previous research indicates that the BAI+SFAS is associated with decreases in DASS scores, and we will evaluate DASS subscale scores as a secondary outcome and mediator of treatment effects.
Change from Baseline in the Short Self-Regulation Questionnaire (SSRQ) at 3-months Enrollment, 3-months post intervention The SSRQ is a reliable and valid measure of the extent to which individuals are able to organize their behavior around the pursuit of goals and has been shown to mediate the drinking reductions associated with the SFAS. We will examine the SSRQ as a secondary intervention outcome and mediator.
Change from Baseline in the Depression, Anxiety, and Stress Scales (DASS) at 3-month Enrollment, 3-months post intervention The DASS is a reliable and valid self-report survey designed to measure symptoms of depression, anxiety and stress. Each of the three DASS scales contains seven items and participants are asked to use 4-point scales to rate the extent to which they have experienced each emotional state over the past week; scores for depression, anxiety and stress are calculated by summing the scores. For the purpose of this study, we will only include the depression and anxiety subscale items. Previous research indicates that the BAI+SFAS is associated with decreases in DASS scores, and we will evaluate DASS subscale scores as a secondary outcome and mediator of treatment effects.
Change from Baseline in the Short Self-Regulation Questionnaire (SSRQ) at 1-month Enrollment, 1-month post intervention The SSRQ is a reliable and valid measure of the extent to which individuals are able to organize their behavior around the pursuit of goals and has been shown to mediate the drinking reductions associated with the SFAS. We will examine the SSRQ as a secondary intervention outcome and mediator.
Change from Baseline in the Short Self-Regulation Questionnaire (SSRQ) at 6-months Enrollment, 6-months post intervention The SSRQ is a reliable and valid measure of the extent to which individuals are able to organize their behavior around the pursuit of goals and has been shown to mediate the drinking reductions associated with the SFAS. We will examine the SSRQ as a secondary intervention outcome and mediator.
Change from Baseline in the Short Self-Regulation Questionnaire (SSRQ) at 12-months Enrollment, 12-months post intervention The SSRQ is a reliable and valid measure of the extent to which individuals are able to organize their behavior around the pursuit of goals and has been shown to mediate the drinking reductions associated with the SFAS. We will examine the SSRQ as a secondary intervention outcome and mediator.
Change from Baseline in the Depression, Anxiety, and Stress Scales (DASS) at 6-months Enrollment, 6-months post intervention The DASS is a reliable and valid self-report survey designed to measure symptoms of depression, anxiety and stress. Each of the three DASS scales contains seven items and participants are asked to use 4-point scales to rate the extent to which they have experienced each emotional state over the past week; scores for depression, anxiety and stress are calculated by summing the scores. For the purpose of this study, we will only include the depression and anxiety subscale items. Previous research indicates that the BAI+SFAS is associated with decreases in DASS scores, and we will evaluate DASS subscale scores as a secondary outcome and mediator of treatment effects.
Anxiety, and Stress Scales (DASS) at 12-months Enrollment, 12-months post intervention The DASS is a reliable and valid self-report survey designed to measure symptoms of depression, anxiety and stress. Each of the three DASS scales contains seven items and participants are asked to use 4-point scales to rate the extent to which they have experienced each emotional state over the past week; scores for depression, anxiety and stress are calculated by summing the scores. For the purpose of this study, we will only include the depression and anxiety subscale items. Previous research indicates that the BAI+SFAS is associated with decreases in DASS scores, and we will evaluate DASS subscale scores as a secondary outcome and mediator of treatment effects.
Trial Locations
- Locations (1)
University of Memphis
🇺🇸Memphis, Tennessee, United States