Alcohol DrinkingNCT05988931
Technology Interventions for Youth Alcohol Use
A study testing Web Program + App and Web Program + App + Text Messages in people with Alcohol Drinking, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of two programs to prevent/reduce alcohol misuse among youth primary care patients. Depending on their study condition, youth will receive a brief web-based computer program or the web program + 8 weeks of supportive text messages. Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Web Program + App and Web Program + App + Text Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,406 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2023to Sep 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 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients age 12-19 within the Michigan Medicine health system who had a visit within the past 2 years; and
- past 12-month alcohol use; and
- patient has a phone that can receive text messages
Who cannot join
- patients who do not understand English; or
- patients deemed unable to provide informed consent due to conditions that preclude understanding of assessment or intervention content; or
- parent/guardian consent is not obtained; or
- another child in household already enrolled in the study; or
- ongoing participation in another behavioral health research study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Scalable Technology-Driven Brief Intervention Packages for Youth Alcohol Use
The purpose of this study is to evaluate the effects of two programs to prevent/reduce alcohol misuse among youth primary care patients. Depending on their study condition, youth will receive a brief web-based computer program or the web program + 8 weeks of supportive text messages. Parents/caregivers of youth are encouraged to use a freely available app to guide conversations with their child about drinking. This study will have significant impact by evaluating response to these scalable interventions which can be deployed widely in clinical care settings.
- Conditions
- Alcohol Drinking
- Being tested
- Web Program + App, Web Program + App + Text Messages
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web Program + AppBehavioural
Youth receive a brief interactive web program made available online to prevent alcohol misuse. The parent/caregiver app addresses monitoring and skill building for parents to communicate with the child about preventing underage drinking and drug use.
Web Program + App + Text MessagesBehavioural
Youth receive a brief interactive web program made available online to prevent alcohol misuse. This is followed by 8 weeks of supportive text messages. The parent/caregiver app addresses monitoring and skill building for parents to communicate with the child about preventing underage drinking and drug use.
| Study group | Role | What they receive |
|---|---|---|
| Web Program + App | Active comparator | Brief intervention web program (rooted in Motivational Interviewing) recommended at enrollment with parent/caregiver recommended to download and use app (with strategies to talk to youth about drinking prevention). Receives: Behavioral: Web Program + App |
| Web Program + App + Text Messages | Active comparator | Brief intervention web program (rooted in Motivational Interviewing) recommended at enrollment with parent/caregiver recommended to download and use app (with strategies to talk to youth about drinking prevention) plus youth receive 8 weeks of text messages. Receives: Behavioral: Web Program + App + Text Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alcohol Consumption
Alcohol consumption will be measured using total score on the 3-item Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) which includes typical quantity and frequency, and frequency of binge drinking (# of drinks modified by age based on the NIAAA Youth Guide). Higher score indicates worse outcomes.
Measured: 3-, 6-, 9- and 12- months post baseline
Secondary outcomes (4)
Change in Alcohol Related Consequences
Alcohol related consequences will be measured using total score on the brief 18-item version of the Rutgers Alcohol Problem Index (RAPI). Higher score indicates worse outcomes.
Measured: 3-, 6-, 9- and 12- months post baseline
Change in Other Drug Use
Other drug use will be measured using scores derived from National Survey on Drug Use and Health (NSDUH) survey items for illicit (e.g., cannabis, cocaine, heroin) and prescription (i.e., in any way a doctor did not direct you to use; stimulants, sedatives, and opioids) drugs misuse. Higher scores indicate worse outcomes.
Measured: 3-, 6-, 9- and 12- months post baseline
Change in Other Drug Use Consequences
Other drug use consequences will be measured using total score on an 18-item version of the drug-focused RAPI. Higher score indicates worse outcomes.
Measured: 3-, 6-, 9- and 12- months post baseline
Change in Depression Symptoms
Depressive symptoms will be measured using the Patient Health Questionnaire-2 (PHQ-2). Higher scores indicate worse outcomes, with a score of ≥ 3 indicating a positive depression screen.
Measured: 3-, 6-, 9- and 12-month post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start25 Oct 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- 1,406 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Maureen A Walton, University of Michigan
- Investigators
- Maureen Walton, MPH, PhD, Principal investigator, University of MichiganErin Bonar, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988931
- Sponsor's protocol ID
- HUM00232130
- Other IDs
- AU-2022C1-25631
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Scalable Technology-Driven Brief Intervention Packages for Youth Alcohol Use
- ClinicalTrials.gov ID
- NCT05988931
- Acronym / sponsor ID
- HUM00232130
- Conditions
- Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,406 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 14 Aug 2023 (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.
The purpose of this study is to evaluate the effects of two programs to prevent/reduce alcohol misuse among youth primary care patients. Depending on their study condition, youth will receive a brief web-based computer program or the web program + 8 weeks of supportive text messages. Parents/caregivers of youth are encouraged to use a freely available app to guide conversations with their child about drinking. This study will have significant impact by evaluating response to these scalable interventions which can be deployed widely in clinical care settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web Program + App | Active comparator | Behavioral: Web Program + AppBrief intervention web program (rooted in Motivational Interviewing) recommended at enrollment with parent/caregiver recommended to download and use app (with strategies to talk to youth about drinking prevention). |
| Web Program + App + Text Messages | Active comparator | Behavioral: Web Program + App + Text MessagesBrief intervention web program (rooted in Motivational Interviewing) recommended at enrollment with parent/caregiver recommended to download and use app (with strategies to talk to youth about drinking prevention) plus youth receive 8 weeks of text messages. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- patients age 12-19 within the Michigan Medicine health system who had a visit within the past 2 years; and
- past 12-month alcohol use; and
- patient has a phone that can receive text messages
Key exclusion criteria (5 listed)
- patients who do not understand English; or
- patients deemed unable to provide informed consent due to conditions that preclude understanding of assessment or intervention content; or
- parent/guardian consent is not obtained; or
- another child in household already enrolled in the study; or
- ongoing participation in another behavioral health research study
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 |
|---|---|---|
| Web Program + AppYouth receive a brief interactive web program made available online to prevent alcohol misuse. The parent/caregiver app addresses monitoring and skill building for parents to communicate with the child about preventing underage drinking and drug use. | Behavioural | Web Program + App |
| Web Program + App + Text MessagesYouth receive a brief interactive web program made available online to prevent alcohol misuse. This is followed by 8 weeks of supportive text messages. The parent/caregiver app addresses monitoring and skill building for parents to communicate with the child about preventing underage drinking and drug use. | Behavioural | Web Program + App + Text Messages |
Primary outcome
Change in Alcohol Consumption
Time frame: 3-, 6-, 9- and 12- months post baseline
Alcohol consumption will be measured using total score on the 3-item Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) which includes typical quantity and frequency, and frequency of binge drinking (# of drinks modified by age based on the NIAAA Youth Guide). Higher score indicates worse outcomes.
4 secondary outcomes
Change in Alcohol Related Consequences
Time frame: 3-, 6-, 9- and 12- months post baseline
Change in Other Drug Use
Time frame: 3-, 6-, 9- and 12- months post baseline
Change in Other Drug Use Consequences
Time frame: 3-, 6-, 9- and 12- months post baseline
Change in Depression Symptoms
Time frame: 3-, 6-, 9- and 12-month post baseline
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 28 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Maureen Walton, MPH, PhD principal investigator
University of Michigan
Erin Bonar, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web Program + App and Web Program + App + Text Messages in people with Alcohol Drinking, run by University of Michigan 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 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?
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?
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?
Change in Alcohol Consumption (time frame: 3-, 6-, 9- and 12- months post baseline). 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 28 Aug 2026.