Alcohol AbusePhase 3NCT00246428
Motivational Interviewing for Alcohol-Positive Teens in the Emergency Room
A Phase 3 study testing Individual Motivational Interview (IMI) and Individual Motivational Interview + Family Check-Up in people with Alcohol Abuse and Alcohol Dependence, run by Brown University at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether motivational interviewing is effective in reducing alcohol consumption and alcohol problems among young adults who present to an Emergency Room. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Alcohol Abuse, Alcohol Dependence
- What is being tested?
- Individual Motivational Interview (IMI) and Individual Motivational Interview + Family Check-Up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2003to 30 Apr 2008
- Phase
- Phase 3
- 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
- Admitted to ER
- Between 18-24 years old
- Had a blood alcohol concentration (BAC) greater than .01% according to a biochemical test OR self-reported drinking alcohol in the 6 hours prior to the event that caused their hospital visit OR scored 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT)
Who cannot join
- Not English-speaking
- Had a self-inflicted injury
- In police custody
- Did not pass a mental status exam
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rhode Island Hospital
Providence, Rhode Island, 02903
Brown University
Providence, Rhode Island, 02912
About this study
Official title: Motivational Interviewing (MI) for ETOH+ Teens in the ER
The purpose of this study is to determine whether motivational interviewing is effective in reducing alcohol consumption and alcohol problems among young adults who present to an Emergency Room.
Read the detailed description
The long term objectives of this program of research are to develop effective interventions for reducing problem drinking and associated problems among adolescents and young adults and to further enhance intervention approaches by identifying effective elements of treatment derived from cognitive behavioral social learning theory. Current approaches to behavior change in this area frequently rely on school-based primary prevention programs that do not address cessation/reduction issues for adolescents who are already drinking, rarely address motivational issues related to use and abuse, and cannot target school dropouts. Recently, two studies have shown Motivational Interviewing (MI) to be effective with alcohol-involved adolescents when compared to a control or no intervention condition, but have shown greater harm-reduction effects than alcohol consumption effects. In addition, mechanisms of MI have not been elucidated. The major purposes of this study re to compare MI to a minimal contrast condition in which personalized feedback is provided, and to determine if additional booster sessions will enhance outcomes. The population is older adolescents who have been treated in an Emergency Department (ED) following an alcohol-related event. Thus, school dropouts, a high-risk population, will be included in the study. A 2 (MI versus Feedback Only) x 2 (two booster sessions versus no boosters) factorial design will be used to examine whether a MI combined with booster can effectively change subsequent alcohol use and alcohol problems. Experimental manipulations will be evaluated 6, 9, and 12 months after baseline intervention. The study design has several strengths: (1) it will enable an investigation of the main effects of MI versus Feedback Only, providing a more stringent test of the active ingredients of MI than our current competitive segment permitted; (2) it enables an evaluation of the effects of continued contact as a separate factor; and (3) it allows a test of the interaction between baseline intervention type and booster contact. A secondary purpose of the study is to use explicit mediational analyses, tested within a Structural Equation Modeling framework, to examine the hypothesis that stage of change, use of behavioral alcohol reduction strategies, and alcohol treatment seeking will mediate the relationship between intervention and outcome. Finally, the study will determine whether the diagnosis of alcohol abuse or dependence affects responsivity to our intervention. In addition to its potential contribut8ion to theory, the importance of this work is its potential for providing a cos-effective brief intervention at a "teachable moment" to increase high-risk patients' interest in reducing harmful drinking and related risk-taking behaviors.
- Conditions
- Alcohol Abuse, Alcohol Dependence
- Being tested
- Individual Motivational Interview (IMI), Individual Motivational Interview + Family Check-Up
- Keywords
- Motivational Interviewing, Alcohol Abuse, Alcohol Dependence, Emergency Care Setting
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Motivational Interview (IMI)Behavioural
Also called IMI
Individual counseling sessions with emphasis in personal responsibility, exploration of motivation for drinking and review of potential negative consequences. will be evaluated 6, 9, and 12 months
Individual Motivational Interview + Family Check-UpBehavioural
Also called FAsTask
One hour videotaped session of family assessment
| Study group | Role | What they receive |
|---|---|---|
| Individual Interventional Inteview | Experimental | 45 minute counseling session Receives: Behavioral: Individual Motivational Interview (IMI) |
| Individual Motivational Interview + Family Check UP | Experimental | Same counseling session as Individual Motivational Interview plus a one hour videotaped family assessment, consisting of the parents and the adolescents discussion family beliefs regarding alcohol, and marijuana. Receives: Behavioral: Individual Motivational Interview + Family Check-Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Consumption
Measured: 6, 9, and 12 months
Secondary outcomes (1)
Alcohol-related problems (e.g., drinking and driving)
Measured: 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study start1 Jan 2003
- Primary completion31 Jan 2008
- Study completion30 Apr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group randomized design
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Peter Monti, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246428
- Sponsor's protocol ID
- NIAAAMON09892-10
- Other IDs
- R01AA009892, NIH Grant AA09892-10
- Status last verified
- Jun 2025
- First submitted
- 27 Oct 2005
- Last updated
- 13 Jun 2025
- Results posted
- No
Publications
Barnett NP, Apodaca TR, Magill M, Colby SM, Gwaltney C, Rohsenow DJ, Monti PM. Moderators and mediators of two brief interventions for alcohol in the emergency department. Addiction. 2010 Mar;105(3):452-65. doi: 10.1111/j.1360-0443.2009.02814.x.
PubMed 20402989
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing (MI) for ETOH+ Teens in the ER
- ClinicalTrials.gov ID
- NCT00246428
- Acronym / sponsor ID
- NIAAAMON09892-10
- Conditions
- Alcohol Abuse, Alcohol Dependence
- Keywords
- Motivational Interviewing, Alcohol Abuse, Alcohol Dependence, Emergency Care Setting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 31 Jan 2008 (actual)
- Study completion
- 30 Apr 2008 (actual)
- First posted
- 31 Oct 2005 (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.
The purpose of this study is to determine whether motivational interviewing is effective in reducing alcohol consumption and alcohol problems among young adults who present to an Emergency Room.
Detailed description
The long term objectives of this program of research are to develop effective interventions for reducing problem drinking and associated problems among adolescents and young adults and to further enhance intervention approaches by identifying effective elements of treatment derived from cognitive behavioral social learning theory. Current approaches to behavior change in this area frequently rely on school-based primary prevention programs that do not address cessation/reduction issues for adolescents who are already drinking, rarely address motivational issues related to use and abuse, and cannot target school dropouts. Recently, two studies have shown Motivational Interviewing (MI) to be effective with alcohol-involved adolescents when compared to a control or no intervention condition, but have shown greater harm-reduction effects than alcohol consumption effects. In addition, mechanisms of MI have not been elucidated. The major purposes of this study re to compare MI to a minimal contrast condition in which personalized feedback is provided, and to determine if additional booster sessions will enhance outcomes. The population is older adolescents who have been treated in an Emergency Department (ED) following an alcohol-related event. Thus, school dropouts, a high-risk population, will be included in the study. A 2 (MI versus Feedback Only) x 2 (two booster sessions versus no boosters) factorial design will be used to examine whether a MI combined with booster can effectively change subsequent alcohol use and alcohol problems. Experimental manipulations will be evaluated 6, 9, and 12 months after baseline intervention. The study design has several strengths: (1) it will enable an investigation of the main effects of MI versus Feedback Only, providing a more stringent test of the active ingredients of MI than our current competitive segment permitted; (2) it enables an evaluation of the effects of continued contact as a separate factor; and (3) it allows a test of the interaction between baseline intervention type and booster contact. A secondary purpose of the study is to use explicit mediational analyses, tested within a Structural Equation Modeling framework, to examine the hypothesis that stage of change, use of behavioral alcohol reduction strategies, and alcohol treatment seeking will mediate the relationship between intervention and outcome. Finally, the study will determine whether the diagnosis of alcohol abuse or dependence affects responsivity to our intervention. In addition to its potential contribut8ion to theory, the importance of this work is its potential for providing a cos-effective brief intervention at a "teachable moment" to increase high-risk patients' interest in reducing harmful drinking and related risk-taking behaviors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two group randomized design
| Arm | Type | Receives |
|---|---|---|
| Individual Interventional Inteview | Experimental | Behavioral: Individual Motivational Interview (IMI)45 minute counseling session |
| Individual Motivational Interview + Family Check UP | Experimental | Behavioral: Individual Motivational Interview + Family Check-UpSame counseling session as Individual Motivational Interview plus a one hour videotaped family assessment, consisting of the parents and the adolescents discussion family beliefs regarding alcohol, and marijuana. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Admitted to ER
- Between 18-24 years old
- Had a blood alcohol concentration (BAC) greater than .01% according to a biochemical test OR self-reported drinking alcohol in the 6 hours prior to the event that caused their hospital visit OR scored 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT)
Key exclusion criteria (4 listed)
- Not English-speaking
- Had a self-inflicted injury
- In police custody
- Did not pass a mental status exam
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 |
|---|---|---|
| Individual Motivational Interview (IMI)Also: IMIIndividual counseling sessions with emphasis in personal responsibility, exploration of motivation for drinking and review of potential negative consequences. will be evaluated 6, 9, and 12 months | Behavioural | Individual Interventional Inteview |
| Individual Motivational Interview + Family Check-UpAlso: FAsTaskOne hour videotaped session of family assessment | Behavioural | Individual Motivational Interview + Family Check UP |
Primary outcome
Alcohol Consumption
Time frame: 6, 9, and 12 months
1 secondary outcome
Alcohol-related problems (e.g., drinking and driving)
Time frame: 6, 9, and 12 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 13 Jun 2025.
- Derived from this study: PubMed 20402989Barnett NP, Apodaca TR, Magill M, Colby SM, Gwaltney C, Rohsenow DJ, Monti PM. Moderators and mediators of two brief interventions for alcohol in the emergency department. Addiction. 2010 Mar;105(3):452-65. doi: 10.1111/j.1360-0443.2009.02814.x.
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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.
Peter Monti, PhD principal investigator
Brown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Individual Motivational Interview (IMI) and Individual Motivational Interview + Family Check-Up in people with Alcohol Abuse and Alcohol Dependence, run by Brown University at 2 sites 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 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Alcohol Consumption (time frame: 6, 9, and 12 months). 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 NCT00246428, which also lists 1 linked publication.
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 13 Jun 2025.