Alcohol Drinking in CollegeNCT05011903
Integrative Alcohol and Risky Sex Feedback for College Students
A study testing Cross-tailored Dynamic Feedback, Personalized Feedback Intervention and Dynamic Feedback on General Health Behaviors in people with Alcohol Drinking in College and Sexual Behavior, run by Anne E Ray at 2 sites in United States.
Trial summary
Alcohol misuse and related risky sexual behaviors are significant health concerns for college students. Two-thirds of students are current drinkers, at least 1 in 3 report past month heavy episodic drinking (5+ drinks in a row), and 1 in 10 report high intensity drinking (10+ drinks in a row). Read more about this study
- Who is it for?
- Ages 18 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking in College, Sexual Behavior
- What is being tested?
- Cross-tailored Dynamic Feedback, Personalized Feedback Intervention and Dynamic Feedback on General Health Behaviors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 20 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- status as first-year college student at University of Kentucky or UNT-Denton
- 18-20 years old
Who cannot join
- the inability or unwillingness to give informed, voluntary consent to participate
- not meeting inclusion criteria
- currently in treatment to reduce alcohol or other substance use
- pregnant or planning to become pregnant
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of North Texas Health Science Center at Fort Worth
Fort Worth, Texas, 76107
Eun-Young Mun, PhD, 8177355158, eun-young.mun@unthsc.edu
Eun-Young Mun, PhD
University of Kentucky
Lexington, Kentucky, 40506
Anne E Ray, PhD, 8592184944, anne.ray@uky.edu
Anne E Ray, PhD
About this study
Official title: Cross-Tailoring Integrative Alcohol and Risky Sex Feedback for College Students: A Hybrid Type 1 Effectiveness-Implementation Trial
Alcohol misuse and related risky sexual behaviors are significant health concerns for college students. Two-thirds of students are current drinkers, at least 1 in 3 report past month heavy episodic drinking (5+ drinks in a row), and 1 in 10 report high intensity drinking (10+ drinks in a row). Increased student alcohol use and heavy drinking are linked to increased sexual activity and related risky behaviors (e.g., unprotected sex, sex with casual partners). This puts students at risk for negative health outcomes (e.g., STIs - sexually transmitted infections) and is also a pathway to sexual victimization and escalated drinking. The first few weeks of college, known as the 'red zone,' provide an opportunity to intervene at time when these behaviors increase. However, most prevention programs for college students tend to focus on student alcohol use and have little to no integration of content on the relationship between alcohol use and risky sexual behaviors. This is an important gap in the literature and a priority area for NIAAA. The research team established the short-term efficacy of a personalized feedback intervention (PFI), a gold standard intervention approach, with integrated content on alcohol and risky sexual behaviors. In this study, we propose to extend our integrated PFI to include a cross-tailored dynamic feedback (CDF) component. The CDF component will use technology to incorporate daily assessments of student behavior and provide students with dynamic weekly feedback over 12 weeks. The goal is to increase the effectiveness of the integrated PFI and to create a program that is easily implemented on college campuses.
Read the detailed description
The project utilizes a multisite, hybrid type 1 effectiveness-implementation study design to (1) evaluate the impact of CDF for first-year college students and (2) identify implementation factors critical to its success to facilitate future scale-up in campus settings. The first aim is to conduct a multi-level stakeholder-engaged adaptation of the integrated alcohol and risky sex PFI through the development and inclusion of CDF. The second aim is to conduct a randomized controlled trial (RCT) of the enhanced intervention (PFI+CDF) in a sample of 600 first-year college students. The primary hypothesis is that participants who receive the PFI+CDF intervention will report less alcohol use, fewer risky sexual behaviors, and fewer consequences relative to those who receive a PFI supplemented with generic health information at follow-up (1, 2, 3, 6, and 13 months). Participants (N=600 total, 300 per site) will be randomized to 1 of 4 groups: (1) PFI+CDF with weekend diary surveys, (2) PFI+GHI with weekend diary surveys, (3) PFI-only, no weekend diary surveys, and (4) assessment-only control, no weekend diary surveys. All participants will complete a baseline survey during the first week of the semester, be randomly assigned to condition, and complete follow-up surveys at 1, 2, 3, 6, and 13 months. This staggered design allows for comparison of the enhanced PFI+CDF relative to the PFI+GHI condition, which may be consistent with a "treatment-as-usual" comparison group (e.g., of the universities that have adopted an evidence-guided alcohol intervention program for their campus, many currently deliver commercialized alcohol-focused PFIs to incoming first-year students). Providing weekly GHI in the comparison condition allows for an equal number of "exposures" between the more intensive conditions (PFI+CDF vs. PFI+GHI), analogous to an attention control group, offering a clearer understanding of the overall impact of the PFI+CDF adaptation. The inclusion of two PFI conditions, one with weekend diary assessments and one without allows us to control for potential assessment reactivity that might result from the diary-style assessment approach. Overall, this design is intended to allow a separation of the "true" intervention effect of the CDF above and beyond the effect of assessment reactivity. The PFI-only vs. assessment-only control group comparison will provide a test of basic efficacy of the integrated PFI that has been adapted based on stakeholder feedback. The third aim seeks to identify factors critical to PFI+CDF implementation in campus settings through conducting focus groups with a subset of students from the RCT and with local and national systems-level stakeholders. The intervention has strong potential for widespread dissemination and targets a group at high risk for alcohol misuse and RSB.
- Conditions
- Alcohol Drinking in College, Sexual Behavior
- Being tested
- Cross-tailored Dynamic Feedback, Personalized Feedback Intervention, Dynamic Feedback on General Health Behaviors
- Medical subject headings
- Alcohol Drinking in College, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-tailored Dynamic FeedbackBehavioural
Dynamic, technology-delivered weekly feedback on weekend diary self-reports of first-year college student behavior related to alcohol use and related sexual behaviors.
Personalized Feedback InterventionBehavioural
Technology-delivered personalized feedback on first-year college student behavior related to alcohol use and related sexual behaviors.
Dynamic Feedback on General Health BehaviorsBehavioural
Dynamic, technology-delivered weekly feedback on weekend diary self-reports of first-year college student behavior related to general health behaviors.
| Study group | Role | What they receive |
|---|---|---|
| PFI+CDF with diary surveys | Experimental | Participants in this condition receive a Personalized Feedback Intervention (PFI) and Cross-tailored Dynamic Feedback (CDF) related to alcohol use and related sexual behavior. They also complete weekend diary surveys in which they are asked to self-report on weekend behaviors. Receives: Behavioral: Cross-tailored Dynamic Feedback; Behavioral: Personalized Feedback Intervention |
| PFI+GHI with diary surveys | Experimental | Participants in this condition receive a Personalized Feedback Intervention (PFI) related to alcohol use and related sexual behavior, and generic health information (GHI). They also complete weekend diary surveys in which they are asked to self-report on weekend behaviors. Receives: Behavioral: Personalized Feedback Intervention; Behavioral: Dynamic Feedback on General Health Behaviors |
| PFI-only with no diary surveys | Experimental | Participants in this condition receive a Personalized Feedback Intervention (PFI) related to alcohol use and related sexual behavior. They do not complete weekend diary surveys. Receives: Behavioral: Personalized Feedback Intervention |
| Control | No intervention | Participants in this condition get no intervention and do not complete weekend diary surveys. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported alcohol-related sexual behavior frequency
Number of times alcohol was consumed during or before sex in the last month
Measured: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported alcohol-related sexual behavior quantity
Number of alcoholic beverages consumed before sex in the last month
Measured: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported alcohol-related hook-ups
Number of alcohol-related hook-ups experienced in the last month
Measured: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported alcohol-related sexual behavior consequences
Number of alcohol-related sexual consequences experienced in the last month
Measured: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Secondary outcomes (4)
Change in self-reported alcohol use quantity
Typical number of drinks consumed on each day of week in the last month
Measured: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported heavy episodic drinking
Number of heavy drinking episodes (4+ drinks female, 5+ drinks male) in the last month
Measured: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported quantity of sex partners
Number of casual sex partners in the last month
Measured: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported condom use
Number of times condom was used during sex in the last month
Measured: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study startOct 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Drinking in CollegeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anne E Ray
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Texas Health Science Center, Klein Buendel, Inc., National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Anne E Ray, University of Kentucky
- Investigators
- Anne E Ray, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011903
- Sponsor's protocol ID
- 62769
- Other IDs
- R01AA028246
- Status last verified
- Sep 2026
- First submitted
- 10 Aug 2021
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available to qualified researchers after the main findings are published in a peer-reviewed journal upon request. All data sharing will comply with local, state, and federal laws and regulations, including HIPAA Privacy and Security Rules. Data will be de-identified before presentations and publications, as well as any datasets shared with qualified researchers.
Publications
Ray AE, Mun EY, Lewis MA, Litt DM, Stapleton JL, Tan L, Buller DB, Zhou Z, Bush HM, Himelhoch S. Cross-Tailoring Integrative Alcohol and Risky Sexual Behavior Feedback for College Students: Protocol for a Hybrid Type 1 Effectiveness-Implementation Trial. JMIR Res Protoc. 2023 Mar 20;12:e43986. doi: 10.2196/43986.
PubMed 36716301
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Tailoring Integrative Alcohol and Risky Sex Feedback for College Students: A Hybrid Type 1 Effectiveness-Implementation Trial
- ClinicalTrials.gov ID
- NCT05011903
- Acronym / sponsor ID
- 62769
- Conditions
- Alcohol Drinking in College, Sexual Behavior
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Anne E RayUniversity, hospital or other
- Collaborators
- University of North Texas Health Science Center, Klein Buendel, Inc., National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Oct 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 18 Aug 2021 (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.
Alcohol misuse and related risky sexual behaviors are significant health concerns for college students. Two-thirds of students are current drinkers, at least 1 in 3 report past month heavy episodic drinking (5+ drinks in a row), and 1 in 10 report high intensity drinking (10+ drinks in a row). Increased student alcohol use and heavy drinking are linked to increased sexual activity and related risky behaviors (e.g., unprotected sex, sex with casual partners). This puts students at risk for negative health outcomes (e.g., STIs - sexually transmitted infections) and is also a pathway to sexual victimization and escalated drinking. The first few weeks of college, known as the 'red zone,' provide an opportunity to intervene at time when these behaviors increase. However, most prevention programs for college students tend to focus on student alcohol use and have little to no integration of content on the relationship between alcohol use and risky sexual behaviors. This is an important gap in the literature and a priority area for NIAAA. The research team established the short-term efficacy of a personalized feedback intervention (PFI), a gold standard intervention approach, with integrated content on alcohol and risky sexual behaviors. In this study, we propose to extend our integrated PFI to include a cross-tailored dynamic feedback (CDF) component. The CDF component will use technology to incorporate daily assessments of student behavior and provide students with dynamic weekly feedback over 12 weeks. The goal is to increase the effectiveness of the integrated PFI and to create a program that is easily implemented on college campuses.
Detailed description
The project utilizes a multisite, hybrid type 1 effectiveness-implementation study design to (1) evaluate the impact of CDF for first-year college students and (2) identify implementation factors critical to its success to facilitate future scale-up in campus settings. The first aim is to conduct a multi-level stakeholder-engaged adaptation of the integrated alcohol and risky sex PFI through the development and inclusion of CDF. The second aim is to conduct a randomized controlled trial (RCT) of the enhanced intervention (PFI+CDF) in a sample of 600 first-year college students. The primary hypothesis is that participants who receive the PFI+CDF intervention will report less alcohol use, fewer risky sexual behaviors, and fewer consequences relative to those who receive a PFI supplemented with generic health information at follow-up (1, 2, 3, 6, and 13 months). Participants (N=600 total, 300 per site) will be randomized to 1 of 4 groups: (1) PFI+CDF with weekend diary surveys, (2) PFI+GHI with weekend diary surveys, (3) PFI-only, no weekend diary surveys, and (4) assessment-only control, no weekend diary surveys. All participants will complete a baseline survey during the first week of the semester, be randomly assigned to condition, and complete follow-up surveys at 1, 2, 3, 6, and 13 months. This staggered design allows for comparison of the enhanced PFI+CDF relative to the PFI+GHI condition, which may be consistent with a "treatment-as-usual" comparison group (e.g., of the universities that have adopted an evidence-guided alcohol intervention program for their campus, many currently deliver commercialized alcohol-focused PFIs to incoming first-year students). Providing weekly GHI in the comparison condition allows for an equal number of "exposures" between the more intensive conditions (PFI+CDF vs. PFI+GHI), analogous to an attention control group, offering a clearer understanding of the overall impact of the PFI+CDF adaptation. The inclusion of two PFI conditions, one with weekend diary assessments and one without allows us to control for potential assessment reactivity that might result from the diary-style assessment approach. Overall, this design is intended to allow a separation of the "true" intervention effect of the CDF above and beyond the effect of assessment reactivity. The PFI-only vs. assessment-only control group comparison will provide a test of basic efficacy of the integrated PFI that has been adapted based on stakeholder feedback. The third aim seeks to identify factors critical to PFI+CDF implementation in campus settings through conducting focus groups with a subset of students from the RCT and with local and national systems-level stakeholders. The intervention has strong potential for widespread dissemination and targets a group at high risk for alcohol misuse and RSB.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PFI+CDF with diary surveys | Experimental | Behavioral: Cross-tailored Dynamic Feedback, Behavioral: Personalized Feedback InterventionParticipants in this condition receive a Personalized Feedback Intervention (PFI) and Cross-tailored Dynamic Feedback (CDF) related to alcohol use and related sexual behavior. They also complete weekend diary surveys in which they are asked to self-report on weekend behaviors. |
| PFI+GHI with diary surveys | Experimental | Behavioral: Personalized Feedback Intervention, Behavioral: Dynamic Feedback on General Health BehaviorsParticipants in this condition receive a Personalized Feedback Intervention (PFI) related to alcohol use and related sexual behavior, and generic health information (GHI). They also complete weekend diary surveys in which they are asked to self-report on weekend behaviors. |
| PFI-only with no diary surveys | Experimental | Behavioral: Personalized Feedback InterventionParticipants in this condition receive a Personalized Feedback Intervention (PFI) related to alcohol use and related sexual behavior. They do not complete weekend diary surveys. |
| Control | No intervention | –Participants in this condition get no intervention and do not complete weekend diary surveys. |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- status as first-year college student at University of Kentucky or UNT-Denton
- 18-20 years old
Key exclusion criteria (4 listed)
- the inability or unwillingness to give informed, voluntary consent to participate
- not meeting inclusion criteria
- currently in treatment to reduce alcohol or other substance use
- pregnant or planning to become pregnant
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 |
|---|---|---|
| Cross-tailored Dynamic FeedbackDynamic, technology-delivered weekly feedback on weekend diary self-reports of first-year college student behavior related to alcohol use and related sexual behaviors. | Behavioural | PFI+CDF with diary surveys |
| Personalized Feedback InterventionTechnology-delivered personalized feedback on first-year college student behavior related to alcohol use and related sexual behaviors. | Behavioural | PFI+CDF with diary surveys, PFI+GHI with diary surveys, PFI-only with no diary surveys |
| Dynamic Feedback on General Health BehaviorsDynamic, technology-delivered weekly feedback on weekend diary self-reports of first-year college student behavior related to general health behaviors. | Behavioural | PFI+GHI with diary surveys |
Primary outcome
Change in self-reported alcohol-related sexual behavior frequency
Time frame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Number of times alcohol was consumed during or before sex in the last month
Change in self-reported alcohol-related sexual behavior quantity
Time frame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Number of alcoholic beverages consumed before sex in the last month
Change in self-reported alcohol-related hook-ups
Time frame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Number of alcohol-related hook-ups experienced in the last month
Change in self-reported alcohol-related sexual behavior consequences
Time frame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Number of alcohol-related sexual consequences experienced in the last month
4 secondary outcomes
Change in self-reported alcohol use quantity
Time frame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported heavy episodic drinking
Time frame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported quantity of sex partners
Time frame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported condom use
Time frame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Derived from this study: PubMed 36716301Ray AE, Mun EY, Lewis MA, Litt DM, Stapleton JL, Tan L, Buller DB, Zhou Z, Bush HM, Himelhoch S. Cross-Tailoring Integrative Alcohol and Risky Sexual Behavior Feedback for College Students: Protocol for a Hybrid Type 1 Effectiveness-Implementation Trial. JMIR Res Protoc. 2023 Mar 20;12:e43986. doi: 10.2196/43986.
- Individual participant dataSharing planned: Yes. Data will be available to qualified researchers after the main findings are published in a peer-reviewed journal upon request. All data sharing will comply with local, state, and federal laws and regulations, including HIPAA Privacy and Security Rules. Data will be de-identified before presentations and publications, as well as any datasets shared with qualified researchers.
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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.
Anne E Ray, PhD principal investigator
University of Kentucky
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cross-tailored Dynamic Feedback, Personalized Feedback Intervention and Dynamic Feedback on General Health Behaviors in people with Alcohol Drinking in College and Sexual Behavior, run by Anne E Ray at 2 sites in United States.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne E Ray, PhD (8592184944, anne.ray@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported alcohol-related sexual behavior frequency (time frame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05011903, which also lists 1 linked publication.
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 10 Sep 2026.