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| ID | Type | Description | Link |
|---|---|---|---|
| K01AA028540 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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This study aims to examine the feasibility and acceptability of a mobile health intervention to reduce alcohol use and related consequences among young adults. Participants will be randomly assigned to either receive access to the mobile health intervention or receive only generic study surveys. Participants will receive text message surveys sent to their personal cellphone for 4 weeks per their assigned trial arm. All participants will receive a post-survey 30 days after their final weekly survey text.
This study aims to determine whether a mobile health intervention to reduce alcohol use and related consequences is acceptable and feasible among young adults who engage in high-intensity drinking (HID; 8+/10+ drinks per drinking occasion for females/males, respectively). The investigators aim to recruit 40 adults between 18-25 years of age who report at least one HID episode in the past 30 days.
After providing informed consent, participants will be randomly assigned to receive the mobile health intervention or control surveys only.
Participants will attend one online study visit to enroll in the study and be assigned to their study arm. All subsequent study activities will be completed asynchronously. Participants will then receive text message prompts and/or surveys to their personal cellphone either Wednesday or Thursday through Sunday for four consecutive weeks. Participants will receive a post-test survey 30 days after their final weekly survey.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Health Intervention | Experimental | Participants will receive access to the mobile health intervention. This includes access to an online dashboard which includes a drink counter, ability to track the number of drinks consumed over the course of the study, ability to set drinking-related goals for oneself, and alcohol-related resources. Participants in the intervention will also receive tailored messages during drinking episodes which target contextual factors to reduce alcohol use. |
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| No-contact control | No Intervention | Participants will receive only morning surveys and the 30-day post-test survey. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Health Intervention to Reduce Alcohol Use Among Young Adults | Behavioral | The mobile just-in-time adaptive intervention consists of 1) a digital participant dashboard and 2) tailored messages delivered to the participant's cellphone addressing the individual and ecological contexts of alcohol use. The web-based intervention dashboard includes: 1) a drink counter for participants to log the number and type of drinks (e.g., beer, wine, mixed drink) they consume in a drinking occasion; 2) a calendar which summarizes the number of days on which a participant has consumed alcohol and the number of drinks consumed over the study period, broken out by drink type; 3) a log where participants can set drinking-related goals and update their progress on those goals; and 4) national and local substance use resources. Participants will receive messages tailored to their drinking situation and ecological context during high-risk drinking times. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Satisfaction with the Intervention | Measured using the following item, "How satisfied are you with your experience using this intervention?" with a 5-point response scale ranging from Not at All Satisfied (1) to Extremely Satisfied (5). A higher score indicates higher satisfaction with the intervention | Assessed 30 days after the last 4-week survey text. |
| Average Engagement with the Intervention Measured by the DCBI Scale | Engagement will be assessed via 8 items from the Digital Behavior Change Intervention (DCBI) Scale. The item stem "How strongly did you experience the following?" will be repeated for the following concepts: interest, intrigue, focus, inattention, distraction, enjoyment, annoyance, and pleasure. All items will be scored on a 7 point scale from Not at All (1) to Extremely (7) and an average composite score will be derived for each participant based on responses across the seven items. Scores range from 1-7, where a higher score indicates higher engagement with the intervention. | Assessed 30 days after the last 4-week survey text. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Drinks Consumed per Drinking Episode | Total number of drinks consumed per drinking occasion will be assessed using 1 item: "How many standard drinks did you consume yesterday?" Response options will range from less than 1 (0) to 10 or more (10). Respondents who input 10 or more drinks will be prompted to input the total number of drinks they consumed. | Four days per week (Thursday-Sunday) for four consecutive weeks (16 total times). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa J Cox, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rosenau Hall | Chapel Hill | North Carolina | 27599 | United States |
The investigator will post de-identified participant data to the National Institute of Mental Health National Data Archive (NDA).
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Data will become available 9/1/2027 and be hosted indefinitely on the NDA repository.
Individuals who meet the data access eligibility criteria set by the NDA may access the IPD.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 11, 2025 | Dec 2, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Average Drinking Level per Drinking Episode | An ordinal measure of drinking level will be calculated based on the total drinks item ("How many standard drinks did you consume yesterday?"). Moderate drinking will be defined as 0-3 drinks for women or 0-4 drinks for men, standard binge drinking will be defined as 4-7 drinks for women or 5-9 drinks for men, and high-intensity drinking will be defined as 8 or more drinks for women or 10 or more drinks for men. | Four days per week (Thursday-Sunday) for four consecutive weeks (16 total times). |
| Frequency Score of Alcohol-Related Consequences Measured by BYAACQ | Alcohol-related consequences will be measured via the 24-item Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ), which lists a variety of alcohol-related consequences and asks participants to endorse (Yes=1; No=0) if they have experienced a specific consequence in the past month. Scores range from 0-24, where a higher score indicates a higher number of alcohol-related consequences experienced. | Assessed 30 days after the last 4-week survey text. |