Alcohol MisuseNCT07126613
Mobile Alcohol Use Intervention
A study testing Mobile Health Intervention to Reduce Alcohol Use Among Young Adults in people with Alcohol Misuse, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Alcohol Misuse
- What is being tested?
- Mobile Health Intervention to Reduce Alcohol Use Among Young Adults
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2025to 6 Jan 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 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-25
- Experience at least one high-intensity drinking episode in the past 30 days
- Able to read and write in English
- Consent to receiving text messages to personal cellphone
- No current history of substance use treatment in the past 12 months
- Did not participate in the Aim 2 technical field trial of the intervention
Who cannot join
- Under 18 or over 25
- Did not experience at least one high-intensity drinking episode in the past 30 days
- Unable to read and write in English
- Does not consent to receive text messages to personal cellphone
- Current or history of substance use treatment in the past 12 months
- Participated in the Aim 2 technical field trial of the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Just-in-Time Adaptive Intervention to Reduce High-Intensity Drinking Among Young Adults
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.
Read the detailed description
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.
- Conditions
- Alcohol Misuse
- Being tested
- Mobile Health Intervention to Reduce Alcohol Use Among Young Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health Intervention to Reduce Alcohol Use Among Young AdultsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mobile Health Intervention to Reduce Alcohol Use Among Young Adults |
| No-contact control | No intervention | Participants will receive only morning surveys and the 30-day post-test survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Assessed 30 days after the last 4-week survey text.
Secondary outcomes (3)
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.
Measured: Four days per week (Thursday-Sunday) for four consecutive weeks (16 total times).
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.
Measured: 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.
Measured: Assessed 30 days after the last 4-week survey text.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start29 Sep 2025
- Primary completion6 Jan 2026
- Study completion6 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol MisuseStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Melissa J Cox, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126613
- Sponsor's protocol ID
- 25-1872
- Other IDs
- K01AA028540
- Status last verified
- Jan 2026
- First submitted
- 11 Aug 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigator will post de-identified participant data to the National Institute of Mental Health National Data Archive (NDA).
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Just-in-Time Adaptive Intervention to Reduce High-Intensity Drinking Among Young Adults
- ClinicalTrials.gov ID
- NCT07126613
- Acronym / sponsor ID
- 25-1872
- Conditions
- Alcohol Misuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 17 Aug 2025 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Health Intervention | Experimental | Behavioral: Mobile Health Intervention to Reduce Alcohol Use Among Young AdultsParticipants 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. |
| No-contact control | No intervention | –Participants will receive only morning surveys and the 30-day post-test survey. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-25
- Experience at least one high-intensity drinking episode in the past 30 days
- Able to read and write in English
- Consent to receiving text messages to personal cellphone
- No current history of substance use treatment in the past 12 months
Key exclusion criteria (6 listed)
- Under 18 or over 25
- Did not experience at least one high-intensity drinking episode in the past 30 days
- Unable to read and write in English
- Does not consent to receive text messages to personal cellphone
- Current or history of substance use treatment in the past 12 months
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 |
|---|---|---|
| Mobile Health Intervention to Reduce Alcohol Use Among Young AdultsThe 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. | Behavioural | Mobile Health Intervention |
Primary outcome
Average Satisfaction with the Intervention
Time frame: Assessed 30 days after the last 4-week survey text.
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
Average Engagement with the Intervention Measured by the DCBI Scale
Time frame: Assessed 30 days after the last 4-week survey text.
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.
3 secondary outcomes
Number of Drinks Consumed per Drinking Episode
Time frame: Four days per week (Thursday-Sunday) for four consecutive weeks (16 total times).
Average Drinking Level per Drinking Episode
Time frame: Four days per week (Thursday-Sunday) for four consecutive weeks (16 total times).
Frequency Score of Alcohol-Related Consequences Measured by BYAACQ
Time frame: Assessed 30 days after the last 4-week survey text.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. The investigator will post de-identified participant data to the National Institute of Mental Health National Data Archive (NDA).
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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.
Melissa J Cox, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health Intervention to Reduce Alcohol Use Among Young Adults in people with Alcohol Misuse, run by University of North Carolina, Chapel Hill at 1 site 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Average Satisfaction with the Intervention (time frame: Assessed 30 days after the last 4-week survey text.). The study lists 2 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 21 Jan 2026.