Alcohol UseTMAPNCT02507115
Text Messaging as a Novel Alcohol Intervention for Community College Students
A study testing TMAP and Mojo Texts in people with Alcohol Use, run by The Miriam Hospital at 1 site in United States.
Trial summary
This project will develop an intervention delivered through text messaging to reduce alcohol consumption and high risk drinking among adults who are enrolled as students in community colleges. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use
- What is being tested?
- TMAP and Mojo Texts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jun 2015
- 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 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18 to 28 Community College student Consume at least 4 drinks in one sitting in the past week
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
The Miriam Hospital- CORO building
Providence, Rhode Island, 02903
About this study
This project will develop an intervention delivered through text messaging to reduce alcohol consumption and high risk drinking among adults who are enrolled as students in community colleges.
Read the detailed description
Heavy alcohol use among community college students is a serious problem, leaving students vulnerable to social and health impairment, physical or sexual assault, unintentional injuries, and death. However, there have been limited efforts to research and treat community college students, despite these students comprising nearly 40% of all college students nationwide. Community college students are diverse in ethnicity, age, socioeconomic status, living situation, and employment status. Thus, successful interventions must be sufficiently flexible to apply across a diverse array of individual characteristics and needs. Unfortunately, there is evidence of great unmet need among this group; community college students drive under the influence of alcohol more frequently than students at four-year colleges, and due to lesser time spent on campus, are less available for in-person interventions coordinated at their college. The long-term objective of this research program is to address a gap in the treatment of heavy alcohol use by the community college population. As a first step toward achieving that goal, this R21 application will develop an intervention that is tailored to the needs of community college students and which uses mobile communications platforms that are already used by the vast majority of this population. Taking this approach, the intervention will be mobile, accessible wherever the user is located, and able to be tailored to individual characteristics. The investigators will begin by presenting out initial intervention design to focus groups (4 groups heavy drinking community college students) and obtaining feedback from key informants (advisory board). The investigators will use feedback from these groups to finalize the design and develop a working prototype, and will then pilot the intervention among heavy drinking community college students (N=10) for six weeks to test the usability and acceptability of the prototype intervention. Participants will be interviewed at the end of the program to provide feedback and evaluate their experience with the system, and content experts will again evaluate the prototype using semi-structured interviews. Finally, the investigators will pilot the modified intervention with heaving drinking community college students (N=40) for six weeks. These participants will be randomly assigned to either the intervention program or a standard intervention (print self-help) with a contact-control. Assessments will be conducted at end-of-treatment, and at 3 and 6 months follow up. These data will be used to guide the planning of a full-scale clinical trial to test the efficacy and cost-effectiveness of the intervention in reducing hazardous drinking among community college students
- Conditions
- Alcohol Use
- Being tested
- TMAP, Mojo Texts
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMAPBehavioural
Text messages for Alcohol Risk Reduction
Mojo TextsBehavioural
Motivational texts not alcohol related
| Study group | Role | What they receive |
|---|---|---|
| TMAP | Experimental | Alcohol-related Text messages 4 days/week for 6 weeks Receives: Behavioral: TMAP |
| Control | Sham comparator | Motivational Text messages 4 days/week for 6 weeks Receives: Behavioral: Mojo Texts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of heavy drinking episodes at six weeks
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startJul 2012
- Primary completionJul 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol UseStudies 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Live Inspired, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507115
- Sponsor's protocol ID
- 1R21AA021014-01A1
- Acronym
- TMAP
- Status last verified
- Jul 2015
- First submitted
- 22 Jul 2015
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bock BC, Rosen RK, Barnett NP, Thind H, Walaska K, Foster R, Deutsch C, Traficante R. Translating Behavioral Interventions Onto mHealth Platforms: Developing Text Message Interventions for Smoking and Alcohol. JMIR Mhealth Uhealth. 2015 Feb 24;3(1):e22. doi: 10.2196/mhealth.3779.
PubMed 25714907Bock BC, Barnett NP, Thind H, Rosen R, Walaska K, Traficante R, Foster R, Deutsch C, Fava JL, Scott-Sheldon LA. A text message intervention for alcohol risk reduction among community college students: TMAP. Addict Behav. 2016 Dec;63:107-13. doi: 10.1016/j.addbeh.2016.07.012. Epub 2016 Jul 18.
PubMed 27450909
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Messaging as a Novel Alcohol Intervention for Community College Students
- ClinicalTrials.gov ID
- NCT02507115
- Acronym / sponsor ID
- TMAP / 1R21AA021014-01A1
- Conditions
- Alcohol Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- Live Inspired, LLC
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Jul 2015 (estimated)
- 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 project will develop an intervention delivered through text messaging to reduce alcohol consumption and high risk drinking among adults who are enrolled as students in community colleges.
Detailed description
Heavy alcohol use among community college students is a serious problem, leaving students vulnerable to social and health impairment, physical or sexual assault, unintentional injuries, and death. However, there have been limited efforts to research and treat community college students, despite these students comprising nearly 40% of all college students nationwide. Community college students are diverse in ethnicity, age, socioeconomic status, living situation, and employment status. Thus, successful interventions must be sufficiently flexible to apply across a diverse array of individual characteristics and needs. Unfortunately, there is evidence of great unmet need among this group; community college students drive under the influence of alcohol more frequently than students at four-year colleges, and due to lesser time spent on campus, are less available for in-person interventions coordinated at their college. The long-term objective of this research program is to address a gap in the treatment of heavy alcohol use by the community college population. As a first step toward achieving that goal, this R21 application will develop an intervention that is tailored to the needs of community college students and which uses mobile communications platforms that are already used by the vast majority of this population. Taking this approach, the intervention will be mobile, accessible wherever the user is located, and able to be tailored to individual characteristics. The investigators will begin by presenting out initial intervention design to focus groups (4 groups heavy drinking community college students) and obtaining feedback from key informants (advisory board). The investigators will use feedback from these groups to finalize the design and develop a working prototype, and will then pilot the intervention among heavy drinking community college students (N=10) for six weeks to test the usability and acceptability of the prototype intervention. Participants will be interviewed at the end of the program to provide feedback and evaluate their experience with the system, and content experts will again evaluate the prototype using semi-structured interviews. Finally, the investigators will pilot the modified intervention with heaving drinking community college students (N=40) for six weeks. These participants will be randomly assigned to either the intervention program or a standard intervention (print self-help) with a contact-control. Assessments will be conducted at end-of-treatment, and at 3 and 6 months follow up. These data will be used to guide the planning of a full-scale clinical trial to test the efficacy and cost-effectiveness of the intervention in reducing hazardous drinking among community college students
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMAP | Experimental | Behavioral: TMAPAlcohol-related Text messages 4 days/week for 6 weeks |
| Control | Sham comparator | Behavioral: Mojo TextsMotivational Text messages 4 days/week for 6 weeks |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age 18 to 28 Community College student Consume at least 4 drinks in one sitting in the past week
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| TMAPText messages for Alcohol Risk Reduction | Behavioural | TMAP |
| Mojo TextsMotivational texts not alcohol related | Behavioural | Control |
Primary outcome
Number of heavy drinking episodes at six weeks
Time frame: 6 weeks
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 25 Apr 2019.
- Background: PubMed 25714907Bock BC, Rosen RK, Barnett NP, Thind H, Walaska K, Foster R, Deutsch C, Traficante R. Translating Behavioral Interventions Onto mHealth Platforms: Developing Text Message Interventions for Smoking and Alcohol. JMIR Mhealth Uhealth. 2015 Feb 24;3(1):e22. doi: 10.2196/mhealth.3779.
- Results publication: PubMed 27450909Bock BC, Barnett NP, Thind H, Rosen R, Walaska K, Traficante R, Foster R, Deutsch C, Fava JL, Scott-Sheldon LA. A text message intervention for alcohol risk reduction among community college students: TMAP. Addict Behav. 2016 Dec;63:107-13. doi: 10.1016/j.addbeh.2016.07.012. Epub 2016 Jul 18.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMAP and Mojo Texts in people with Alcohol Use, run by The Miriam Hospital 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 1 inclusion and 1 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 25 Apr 2019. 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. Some participants in this study may receive a placebo. 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?
Number of heavy drinking episodes at six weeks (time frame: 6 weeks). 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 NCT02507115, which also lists 2 linked publications.
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 25 Apr 2019.