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

September 3, 2025 updated by: James G Murphy, University of Memphis

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
525

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38152
        • University of Memphis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Brief Alcohol Intervention (BAI) + 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).
Behavioral: Brief 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.
Behavioral: Substance-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.
Experimental: Relaxation Training (RT) + 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).
Behavioral: Substance-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.
Behavioral: Relaxation 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.
Active Comparator: 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
Other: Education Control
This 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Alcohol Consumption and Drug Use at 1-month
Time Frame: 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.
Enrollment, 1-month post intervention
Change from Baseline Alcohol Consumption and Drug Use at 3-months
Time Frame: 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.
Enrollment, 3-months post intervention
Change from Baseline Alcohol Consumption and Drug Use at 6-months
Time Frame: 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.
Enrollment, 6-months post-intervention
Change from Baseline Alcohol Consumption and Drug Use at 12-months
Time Frame: 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.
Enrollment, 12-months post intervention
Change from Baseline Alcohol-related Consequences at 1-month
Time Frame: 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.
Enrollment, 1-month
Change from Baseline Alcohol-related Consequences at 3-months
Time Frame: 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.
Enrollment, 3-months
Change from Baseline Alcohol-related Consequences at 6-months
Time Frame: 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.
Enrollment, 6-months
Change from Baseline Alcohol-related Consequences at 12-months
Time Frame: 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.
Enrollment, 12-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Substance-free and Substance-related Activity Participation at 1-month
Time Frame: 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).
Enrollment, 1-month post intervention
Change from Baseline Substance-free and Substance-related Activity Participation at 3-months
Time Frame: 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).
Enrollment, 3-months post intervention
Change from Baseline Substance-free and Substance-related Activity Participation at 6-months
Time Frame: 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).
Enrollment, 6-months post intervention
Change from Baseline Substance-free and Substance-related Activity Participation at 12-months
Time Frame: 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).
Enrollment, 12-months post intervention
Change from Baseline Alcohol Purchase Task responses at 1-month
Time Frame: 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.
Enrollment, 1-month post intervention
Change from Baseline Alcohol Purchase Task responses at 3-months
Time Frame: 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.
Enrollment, 3-months post intervention
Change from Baseline Alcohol Purchase Task responses at 6-months
Time Frame: 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.
Enrollment, 6-months post intervention
Change from Baseline Alcohol Purchase Task responses at 12-months
Time Frame: 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.
Enrollment, 12-months post intervention
Change from Baseline in the Depression, Anxiety, and Stress Scales (DASS) at 1-month
Time Frame: 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.
Enrollment, 1-month post intervention
Change from Baseline in the Depression, Anxiety, and Stress Scales (DASS) at 3-month
Time Frame: 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.
Enrollment, 3-months post intervention
Change from Baseline in the Depression, Anxiety, and Stress Scales (DASS) at 6-months
Time Frame: 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.
Enrollment, 6-months post intervention
Anxiety, and Stress Scales (DASS) at 12-months
Time Frame: 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.
Enrollment, 12-months post intervention
Change from Baseline in the Short Self-Regulation Questionnaire (SSRQ) at 1-month
Time Frame: 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.
Enrollment, 1-month post intervention
Change from Baseline in the Short Self-Regulation Questionnaire (SSRQ) at 3-months
Time Frame: 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.
Enrollment, 3-months post intervention
Change from Baseline in the Short Self-Regulation Questionnaire (SSRQ) at 6-months
Time Frame: 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.
Enrollment, 6-months post intervention
Change from Baseline in the Short Self-Regulation Questionnaire (SSRQ) at 12-months
Time Frame: 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.
Enrollment, 12-months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Memphis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01AA029031 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This study will submit and share data with NIAAA Data Archive (NIAAADA), a data repository housed within the NIMH Data Archive (NDA). We also plan to release the data to qualified researchers who wish to collaborate with the study investigators. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

IPD Sharing Time Frame

In this clinical trial, clinical assessments to establish baseline subject characteristics and eligibility criteria will be collected from all research participants at the screening and randomization visits, prior to the completion of the behavioral intervention. Assessment to measure changes in drinking and other dependent variables will take place a 1, 3, 6, and 12 months post-intervention.

IPD Sharing Access Criteria

Qualified researchers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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