Alcohol AbuseNCT04579068
Decreasing Alcohol Use Through Student Peer Leaders
A study testing Screening and Brief Intervention of Problematic Alcohol Use in people with Alcohol Abuse and Alcohol Drinking, run by Charles Drew University of Medicine and Science.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse, Alcohol Drinking, Alcohol Use Disorder
- What is being tested?
- Screening and Brief Intervention of Problematic Alcohol Use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 21 Aug 2021to 20 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- enrolled student at CDU
- age 18 or older
- Speak and understand English
Who cannot join
- not enrolled as a student at CDU
- Under the age of 18
- Unable to speak English
About this study
Official title: 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
Read the 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.
- Conditions
- Alcohol Abuse, Alcohol Drinking, Alcohol Use Disorder, Alcohol Problem
- Being tested
- Screening and Brief Intervention of Problematic Alcohol Use
- Keywords
- alcohol
- Medical subject headings
- Alcoholism, Alcohol Drinking, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening and Brief Intervention of Problematic Alcohol UseBehavioural
Provide/enhance knowledge, screening and detection, modify attitudes, motivate and provide skills and resources to reduce alcohol related risk and consumption.
| Study group | Role | What they receive |
|---|---|---|
| Screening and Brief Intervention of Problematic Alcohol Use | Experimental | 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. Receives: Behavioral: Screening and Brief Intervention of Problematic Alcohol Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of problematic alcohol use (i.e. HED or AUD) and at-risk alcohol use Using the RAPS4-QF Instrument
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 15 minutes
Percentage of Participants Achieving Decreased Levels of Alcohol Risk Using the SBIRT 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.
Measured: Intervention: 15 minutes; Follow-up Point: 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start21 Aug 2021 (estimated)
- Primary completion21 Aug 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Why it stopped: Study not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon Cobb, PhD, Principal investigator, Charles R. Drew University of Medicine & Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579068
- Sponsor's protocol ID
- AAPLCDU
- Status last verified
- Aug 2022
- First submitted
- 1 Oct 2020
- Last updated
- 19 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Awareness Peer Leaders (AAPL): A Multidisciplinary, Culturally Based Training Program for Underserved Minority Health Professional Students to Increase Alcohol Screening and Intervention
- ClinicalTrials.gov ID
- NCT04579068
- Acronym / sponsor ID
- AAPLCDU
- Conditions
- Alcohol Abuse, Alcohol Drinking, Alcohol Use Disorder, Alcohol Problem
- Keywords
- alcohol
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Study start
- 21 Aug 2021 (estimated)
- Primary completion
- 21 Aug 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening and Brief Intervention of Problematic Alcohol Use | Experimental | Behavioral: Screening and Brief Intervention of Problematic Alcohol UseWe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- enrolled student at CDU
- age 18 or older
- Speak and understand English
Key exclusion criteria (3 listed)
- not enrolled as a student at CDU
- Under the age of 18
- Unable to speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening and Brief Intervention of Problematic Alcohol UseProvide/enhance knowledge, screening and detection, modify attitudes, motivate and provide skills and resources to reduce alcohol related risk and consumption. | Behavioural | Screening and Brief Intervention of Problematic Alcohol Use |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Cobb, PhD principal investigator
Charles R. Drew University of Medicine & Science
Questions about this trial
What is this clinical trial studying?
A study testing Screening and Brief Intervention of Problematic Alcohol Use in people with Alcohol Abuse and Alcohol Drinking, run by Charles Drew University of Medicine and Science.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of problematic alcohol use (i.e. HED or AUD) and at-risk alcohol use Using the RAPS4-QF Instrument (time frame: 15 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.