Alcohol ConsumptionTRACNCT01688245
A Text Message Behavioral Intervention to Reduce Alcohol Consumption in Young Adults
A study testing SMS Assessments & Feedback and SMS Assessments in people with Alcohol Consumption and Alcohol Intoxication, run by University of Pittsburgh at 1 site in United States.
Trial summary
Investigators aim to test the effectiveness of a text-message-based behaivoral intervention in reducing binge drinking among young adults. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Alcohol Consumption, Alcohol Intoxication
- What is being tested?
- SMS Assessments & Feedback and SMS Assessments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 765 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to May 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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- AUDIT-C score 3 or more for women and 4 or more for men
Who cannot join
- Current treatment for psychiatric disease
- Any prior treatment for drug or alcohol use disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center-Mercy Hospital
Pittsburgh, Pennsylvania, 15221
About this study
Investigators aim to test the effectiveness of a text-message-based behaivoral intervention in reducing binge drinking among young adults.
Read the detailed description
Alcohol consumption, especially in the form of heavy episodic drinking (bingeing), is common among young adults. Despite high rates of illness and injury associated with heavy episodic drinking, many young adults are not aware of the risks, few seek help for their drinking and many at-risk are not exposed to prevention-based intervention. Opportunistic screening in hospital Emergency Departments (EDs) tied to behavioral interventions has the potential to prevent future alcohol-related harm among young adults, but efficacy across outcomes has been mixed and large-scale implementation of prevention programs is low. Given the rapidly growing use of cell phone text-messaging (SMS) as a primary form of communication among young adults, SMS could be used to deliver health prevention interventions. We will recruit young adults identified in the ED with hazardous drinking behavior in a 3-arm randomized controlled trial to test the hypothesis that exposure to a 12-week SMS program will result in immediate (3-month) and lasting (6-, and 9-month) decreases in alcohol consumption.
- Conditions
- Alcohol Consumption, Alcohol Intoxication
- Being tested
- SMS Assessments & Feedback, SMS Assessments
- Keywords
- young adults, alcohol consumption, mobile health, text message
- Medical subject headings
- Alcohol Drinking, Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS Assessments & FeedbackBehavioural
Weekly pre-weekend drinking plan and post-weekend drinking outcome assessments with personlaized feedback
SMS AssessmentsBehavioural
Weekly post-weekend drinking outcome assessments
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No SMS dialog |
| SMS Assessments | Active comparator | Weekly post-weekend drinking outcome assessments Receives: Behavioral: SMS Assessments |
| SMS Assessments & Feedback | Experimental | Weekly pre-weekend drinking intention \& post-weekend drinking outcome assessments with personalized feedback and harm-reduction support Receives: Behavioral: SMS Assessments & Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timeline Follow-back Procedure
Measured: 30 Days
Secondary outcomes (1)
Injury Behavior Checklist
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2014
- Study completionMay 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 ConsumptionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 765 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian P Suffoletto, MD MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688245
- Sponsor's protocol ID
- PRO12080344
- Acronym
- TRAC
- Status last verified
- May 2015
- First submitted
- 14 Sep 2012
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Suffoletto B, Kristan J, Chung T, Jeong K, Fabio A, Monti P, Clark DB. An Interactive Text Message Intervention to Reduce Binge Drinking in Young Adults: A Randomized Controlled Trial with 9-Month Outcomes. PLoS One. 2015 Nov 18;10(11):e0142877. doi: 10.1371/journal.pone.0142877. eCollection 2015.
PubMed 26580802Suffoletto B, Callaway CW, Kristan J, Monti P, Clark DB. Mobile phone text message intervention to reduce binge drinking among young adults: study protocol for a randomized controlled trial. Trials. 2013 Apr 3;14:93. doi: 10.1186/1745-6215-14-93.
PubMed 23552023
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Text Message Behavioral Intervention to Reduce Alcohol Consumption in Young Adults
- ClinicalTrials.gov ID
- NCT01688245
- Acronym / sponsor ID
- TRAC / PRO12080344
- Conditions
- Alcohol Consumption, Alcohol Intoxication
- Keywords
- young adults, alcohol consumption, mobile health, text message
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 765 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 Sep 2012 (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.
Investigators aim to test the effectiveness of a text-message-based behaivoral intervention in reducing binge drinking among young adults.
Detailed description
Alcohol consumption, especially in the form of heavy episodic drinking (bingeing), is common among young adults. Despite high rates of illness and injury associated with heavy episodic drinking, many young adults are not aware of the risks, few seek help for their drinking and many at-risk are not exposed to prevention-based intervention. Opportunistic screening in hospital Emergency Departments (EDs) tied to behavioral interventions has the potential to prevent future alcohol-related harm among young adults, but efficacy across outcomes has been mixed and large-scale implementation of prevention programs is low. Given the rapidly growing use of cell phone text-messaging (SMS) as a primary form of communication among young adults, SMS could be used to deliver health prevention interventions. We will recruit young adults identified in the ED with hazardous drinking behavior in a 3-arm randomized controlled trial to test the hypothesis that exposure to a 12-week SMS program will result in immediate (3-month) and lasting (6-, and 9-month) decreases in alcohol consumption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No SMS dialog |
| SMS Assessments | Active comparator | Behavioral: SMS AssessmentsWeekly post-weekend drinking outcome assessments |
| SMS Assessments & Feedback | Experimental | Behavioral: SMS Assessments & FeedbackWeekly pre-weekend drinking intention \& post-weekend drinking outcome assessments with personalized feedback and harm-reduction support |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- AUDIT-C score 3 or more for women and 4 or more for men
Key exclusion criteria (2 listed)
- Current treatment for psychiatric disease
- Any prior treatment for drug or alcohol use disorder
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 |
|---|---|---|
| SMS Assessments & FeedbackWeekly pre-weekend drinking plan and post-weekend drinking outcome assessments with personlaized feedback | Behavioural | SMS Assessments & Feedback |
| SMS AssessmentsWeekly post-weekend drinking outcome assessments | Behavioural | SMS Assessments |
Primary outcome
Timeline Follow-back Procedure
Time frame: 30 Days
1 secondary outcome
Injury Behavior Checklist
Time frame: 3 months
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 27 May 2015.
- Derived from this study: PubMed 26580802Suffoletto B, Kristan J, Chung T, Jeong K, Fabio A, Monti P, Clark DB. An Interactive Text Message Intervention to Reduce Binge Drinking in Young Adults: A Randomized Controlled Trial with 9-Month Outcomes. PLoS One. 2015 Nov 18;10(11):e0142877. doi: 10.1371/journal.pone.0142877. eCollection 2015.
- Derived from this study: PubMed 23552023Suffoletto B, Callaway CW, Kristan J, Monti P, Clark DB. Mobile phone text message intervention to reduce binge drinking among young adults: study protocol for a randomized controlled trial. Trials. 2013 Apr 3;14:93. doi: 10.1186/1745-6215-14-93.
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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.
Brian P Suffoletto, MD MS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS Assessments & Feedback and SMS Assessments in people with Alcohol Consumption and Alcohol Intoxication, run by University of Pittsburgh 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 2 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 27 May 2015. 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?
Timeline Follow-back Procedure (time frame: 30 Days). 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 NCT01688245, 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 27 May 2015.