Decreasing Alcohol Use Through Student Peer Leaders

August 17, 2022 updated by: Charles Drew University of Medicine and Science

Alcohol Awareness Peer Leaders (AAPL): A Multidisciplinary, Culturally Based Training Program for Underserved Minority Health Professional Students to Increase Alcohol Screening and Intervention

Problematic alcohol use can lead to worse social and health related consequences for underserved minorities, requiring urgent intervention. By training underserved minority health professional students, this proposed project will develop and test the feasibility of an innovative and culturally tailored intervention for adults studying at a minority institution, with specific focus on alcohol screening, brief intervention, and referral of treatment (SBIRT). This proposal is expected to have a positive impact on alcohol reduction and prevention for minority communities

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

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

Problematic alcohol use, including alcohol use disorders (AUD) and high episodic drinking (HED), remains a public health crisis among college students, particularly those from underserved minority groups. Less likely to disclose alcohol use, underserved minority college students participate in riskier drinking, attributed to multiple social factors, including racial/ethnic discrimination, financial strain, and neighborhood disadvantage. Faced with worse alcohol health-related consequences, effective interventions to reduce alcohol use among this population is critically needed. To reduce alcohol-related health disparities, the investigators aim to develop a public health-based, comprehensive program (Alcohol Awareness Peer Leaders) that will train underserved minority non-traditional health professional students to conduct alcohol screening, brief intervention, and referral to treatment (SBIRT) by using a culturally sensitive approach and screening tool (Rapid Alcohol Problems Screen - RAPS4-QF). By utilizing a culturally adapted SBIRT curriculum, AAPLs will be able to deliver alcohol education and messaging to motivate alcohol risk reduction and decrease in consumption for non-traditional college students studying at a predominantly minority academic institution in an underserved area. The Andersen Healthcare Utilization Model will be utilized to guide this intervention. This theoretically and culturally tailored proposed project is evidence-informed and promising for underserved minority college students and will be advanced through the following three aims: 1) Using an explanatory-sequential mixed methods design, examine a) alcohol consumption and HED patterns, b) attitudes toward alcohol use, c) social and environmental factors, and d) alcohol-related consequences among minority health professional students, 2) Through training of minority health professional students as Alcohol Awareness Peer Leaders (AAPLs), assess the acceptability and relevance of a peer-based SBIRT that was culturally-tailored based on Aim 1 findings, and 3) To compare the feasibility and effectiveness of delivering a culturally-tailored SBIRT using RAPS4-QF by AAPLs by race/ethnicity, drinking status (abstainer vs. drinker), and adverse life experiences. These outcomes will result in the training of 208 underserved minority AAPLs who will conduct culturally competent and evidence-based alcohol screening, brief intervention, and treatment referral for over 2000 students. The result of this innovative proposal will produce future healthcare professionals who will be a valuable community resource for underserved areas as they can continue to decrease alcohol health disparities for underrepresented minority populations, inducing sustainability.

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

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

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • enrolled student at CDU
  • age 18 or older
  • Speak and understand English

Exclusion Criteria:

  • not enrolled as a student at CDU
  • Under the age of 18
  • Unable to speak English

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: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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: Screening and Brief Intervention of Problematic Alcohol Use
We plan to test the feasibility and effectiveness of the delivery of the peer-based SBIRT using the RAPS4-QF screening tool with CDU students. Furthermore, we will compare delivery by AAPLs' race/ethnicity, drinking status (abstainer vs. non-abstainer), and adverse life experiences. Following the screening by AAPLs, we expect a 30% detection of problematic alcohol use (i.e. high episodic drinking [HED] or AUD) and at-risk alcohol use. Participants that screen positive will receive brief motivational interviewing and referral to treatment and will be contacted 6 months following the SBIRT to assess their drinking behaviors. We expect that participants will decrease their alcohol consumption or drinking risk at the 6-month follow up.
Behavioral: Screening and Brief Intervention of Problematic Alcohol Use
Provide/enhance knowledge, screening and detection, modify attitudes, motivate and provide skills and resources to reduce alcohol related risk and consumption.

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
Detection of problematic alcohol use (i.e. HED or AUD) and at-risk alcohol use Using the RAPS4-QF Instrument
Time Frame: 15 minutes
Following the RAPS4-QF screening by AAPL, we anticipate that we will detect a 30% detection of problematic alcohol use (i.e. HED or AUD) and at-risk alcohol use.
15 minutes
Detection of problematic alcohol use (i.e. HED or AUD) and at-risk alcohol use based on adverse life experiences Using the RAPS4-QF Instrument
Time Frame: 15 minutes
Following the RAPS4-QF screening by AAPL, we anticipate that AAPLs with adverse life experiences will have a 40% detection rate of problematic alcohol use (i.e. HED or AUD) and at-risk alcohol use.
15 minutes
Detection of problematic alcohol use (i.e. HED or AUD) and at-risk alcohol use based on Race/Ethnicity Using the RAPS4-QF Instrument
Time Frame: 15 minutes
Following the RAPS4-QF screening by AAPL, we anticipate that AAPLs with matching race/ethnicity will have a 30% detection rate of problematic alcohol use (i.e. HED or AUD) and at-risk alcohol use.
15 minutes
Detection of problematic alcohol use (i.e. HED or AUD) and at-risk alcohol use based on drinking status Using the RAPS4-QF Instrument
Time Frame: 15 minutes
Following the RAPS4-QF screening by AAPL, we anticipate that AAPLs that are alcohol non-abstainers will have a 30% detection rate of problematic alcohol use (i.e. HED or AUD) and at-risk alcohol use.
15 minutes
Percentage of Participants Achieving Decreased Levels of Alcohol Risk Using the SBIRT Intervention
Time Frame: Intervention: 15 minutes; Follow-up Point: 6 months post-intervention
By comparison of pre-, post- intervention, and six-months follow-up data, we anticipate the following compared to baseline: a 30% change in alcohol risk.
Intervention: 15 minutes; Follow-up Point: 6 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.
Charles Drew University of Medicine and Science

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 (ANTICIPATED)

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.
August 21, 2021

Primary Completion (ANTICIPATED)

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.
August 21, 2026

Study Completion (ANTICIPATED)

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.
October 20, 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).
October 1, 2020

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.
October 6, 2020

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.
October 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

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.
August 19, 2022

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.
August 17, 2022

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.
August 1, 2022

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.
  • AAPLCDU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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