Alcohol AbusePARTNCT01197352
Pilot Study of a Text Message Platform to Reduce Risky Drinking in Young Adults
A study testing Motivational and Normative Feedback and Self-Awareness in people with Alcohol Abuse and Alcohol Consumption, run by University of Pittsburgh at 1 site in United States.
Trial summary
Young adults are in a critical period where they can be influenced to avoid a trajectory of high-risk drinking and harmful outcomes in the later adult years. The Emergency Department might offer a unique opportunity to reach young adults, if an easy to implement screening, brief intervention and referral to treatment… Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Alcohol Abuse, Alcohol Consumption, Drinking Behavior
- What is being tested?
- Motivational and Normative Feedback and Self-Awareness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Feb 2011
- 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 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-24 years
- English speaking
- Owns a personal phone with text messaging
Who cannot join
- Pregnant
- Prisoner
- Treated for alcohol dependence or abuse
- Treated for psychiatric disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center Emergency Department
Pittsburgh, Pennsylvania
About this study
Official title: Pilot Study of a Computer-driven Platform That Uses Text Messages to Collect Drinking Information and Deliver Personalized Motivational Messages to At-risk Young Adults
Young adults are in a critical period where they can be influenced to avoid a trajectory of high-risk drinking and harmful outcomes in the later adult years. The Emergency Department might offer a unique opportunity to reach young adults, if an easy to implement screening, brief intervention and referral to treatment was available. The investigators are investigating the feasibility and accuracy of ED-initiated and outpatient-continued assessment of drinking behavior in young adults using a computer-driven text messaging platform. Based on the subject's response to weekly assessments, the computer platform will send personalized motivational messages in real-time.
Read the detailed description
Greater than 45% of young adults have heavy episodic drinking (HED; 5/4 drinks per occasion form men/women), resulting in significant health risks, including injury and death. Early identification and secondary prevention of HED using screening, brief interventions and referral to treatment (SBIRT) is advocated by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) as a way to reduce injury and health consequences. Each day in the United States, there are over 2700 emergency department (ED) visits associated with alcohol, unfortunately, SBIRT is rarely performed in the ED due to time and training requirements. Our application seeks to solve this problem by integrating SBIRT into ED care through the use of ecological assessments with interventions. We will incorporate components of the NIAAA 2005 Clinicians Guide into automated weekly assessments (EA) and branching algorithms for personalized interventions (EA\&I) delivered in real-time through mobile phone text messaging to young adults with a history of at-risk drinking behavior. We will assess the feasibility of EA\&I to study young adults with a history of at-risk drinking and assess the variability in outcomes in patients undergoing EA\&I, EA or standard care. We expect to find that this ED-initiated and outpatientcontinued platform will improve collection of drinking behavior, delivery of real-world motivational feedback and follow-up in young adults with at-risk drinking histories. We anticipate that short-term HED will be reduced in those subjects randomized to EA\&I. We will use this information to support further studies with adequate power to show ED-initiated EA\&I reduce long-term HED and its adverse consequences in young adults.
- Conditions
- Alcohol Abuse, Alcohol Consumption, Drinking Behavior
- Being tested
- Motivational and Normative Feedback, Self-Awareness
- Keywords
- Alcohol, Abuse, Drinking, Behavior, Text, Computer
- Medical subject headings
- Alcoholism, Alcohol Drinking, Drinking Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational and Normative FeedbackBehavioural
Weekly feedback based on their frequency and degree of at-risk drinking behavior using normative, educational and motivational feedback
Self-AwarenessBehavioural
Weekly queries to raise awareness and allow self-reflection about drinking habits
| Study group | Role | What they receive |
|---|---|---|
| Text message queries with feedback | Experimental | Weekly prompted queries about drinking behavior with personalized feedback. Receives: Behavioral: Motivational and Normative Feedback |
| Text message queries | Active comparator | Weekly prompted queries about drinking behavior Receives: Behavioral: Self-Awareness |
| Control | No intervention | Weekly text reminders to complete final (12 week) instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of system to collect drinking information from young adults
We will report the proportion of weeks with completed drinking assessments in the EA and EA\&I groups.
Measured: 12 weeks
Secondary outcomes (1)
Number of binge drinking episodes in subjects as a measure of safety and efficacy
We will compare the number of binge drinking episodes between subjects in the three groups.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197352
- Sponsor's protocol ID
- PRO10040186
- Acronym
- PART
- Status last verified
- May 2012
- First submitted
- 20 Aug 2010
- Last updated
- 21 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Computer-driven Platform That Uses Text Messages to Collect Drinking Information and Deliver Personalized Motivational Messages to At-risk Young Adults
- ClinicalTrials.gov ID
- NCT01197352
- Acronym / sponsor ID
- PART / PRO10040186
- Conditions
- Alcohol Abuse, Alcohol Consumption, Drinking Behavior
- Keywords
- Alcohol, Abuse, Drinking, Behavior, Text, Computer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 9 Sep 2010 (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.
Young adults are in a critical period where they can be influenced to avoid a trajectory of high-risk drinking and harmful outcomes in the later adult years. The Emergency Department might offer a unique opportunity to reach young adults, if an easy to implement screening, brief intervention and referral to treatment was available. The investigators are investigating the feasibility and accuracy of ED-initiated and outpatient-continued assessment of drinking behavior in young adults using a computer-driven text messaging platform. Based on the subject's response to weekly assessments, the computer platform will send personalized motivational messages in real-time.
Detailed description
Greater than 45% of young adults have heavy episodic drinking (HED; 5/4 drinks per occasion form men/women), resulting in significant health risks, including injury and death. Early identification and secondary prevention of HED using screening, brief interventions and referral to treatment (SBIRT) is advocated by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) as a way to reduce injury and health consequences. Each day in the United States, there are over 2700 emergency department (ED) visits associated with alcohol, unfortunately, SBIRT is rarely performed in the ED due to time and training requirements. Our application seeks to solve this problem by integrating SBIRT into ED care through the use of ecological assessments with interventions. We will incorporate components of the NIAAA 2005 Clinicians Guide into automated weekly assessments (EA) and branching algorithms for personalized interventions (EA\&I) delivered in real-time through mobile phone text messaging to young adults with a history of at-risk drinking behavior. We will assess the feasibility of EA\&I to study young adults with a history of at-risk drinking and assess the variability in outcomes in patients undergoing EA\&I, EA or standard care. We expect to find that this ED-initiated and outpatientcontinued platform will improve collection of drinking behavior, delivery of real-world motivational feedback and follow-up in young adults with at-risk drinking histories. We anticipate that short-term HED will be reduced in those subjects randomized to EA\&I. We will use this information to support further studies with adequate power to show ED-initiated EA\&I reduce long-term HED and its adverse consequences in young adults.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Text message queries with feedback | Experimental | Behavioral: Motivational and Normative FeedbackWeekly prompted queries about drinking behavior with personalized feedback. |
| Text message queries | Active comparator | Behavioral: Self-AwarenessWeekly prompted queries about drinking behavior |
| Control | No intervention | –Weekly text reminders to complete final (12 week) instruments |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-24 years
- English speaking
- Owns a personal phone with text messaging
Key exclusion criteria (4 listed)
- Pregnant
- Prisoner
- Treated for alcohol dependence or abuse
- Treated for psychiatric 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 |
|---|---|---|
| Motivational and Normative FeedbackWeekly feedback based on their frequency and degree of at-risk drinking behavior using normative, educational and motivational feedback | Behavioural | Text message queries with feedback |
| Self-AwarenessWeekly queries to raise awareness and allow self-reflection about drinking habits | Behavioural | Text message queries |
Primary outcome
Ability of system to collect drinking information from young adults
Time frame: 12 weeks
We will report the proportion of weeks with completed drinking assessments in the EA and EA\&I groups.
1 secondary outcome
Number of binge drinking episodes in subjects as a measure of safety and efficacy
Time frame: 12 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 21 May 2012.
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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 Motivational and Normative Feedback and Self-Awareness in people with Alcohol Abuse and Alcohol Consumption, 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 3 inclusion and 4 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 May 2012. 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?
Ability of system to collect drinking information from young adults (time frame: 12 weeks). 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 May 2012.