InjuriesNCT00132262
Brief Intervention to Reduce Injury in Minorities
A study testing Brief intervention based on motivational interviewing in people with Injuries and Alcohol Related Disorders, run by The University of Texas Health Science Center, Houston.
Trial summary
The purpose of this study is to evaluate the effectiveness and ethnic differences of a brief alcohol intervention for injured patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injuries, Alcohol Related Disorders
- What is being tested?
- Brief intervention based on motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,493 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Dec 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission for treatment of an injury
- Self identification of Black, White or Hispanic Ethnicity
- Age > 17
- Screen positive for potential alcohol related injury based upon clinical indication of alcohol use prior to injury including positive blood alcohol concentration, self report of alcohol use prior to injury, heavy drinking or drinking beyond normal limits as defined by NIAAA
Who cannot join
- Glasgow Coma Score or GCS < 14
- Admission for self inflicted injury
About this study
The purpose of this study is to evaluate the effectiveness and ethnic differences of a brief alcohol intervention for injured patients.
Read the detailed description
Injuries are not isolated events or one time occurrences and injury has been identified as an important public health problem. Among the risk factors associated with injury and injury recidivism, the most widely recognized is alcohol use with approximately 50% of all injuries associated with alcohol. In general, alcohol use and drinking patterns vary by ethnicity, with frequent heavy drinking and associated problems more common among Blacks and Hispanics. Blacks, in general, suffer a disproportionate level of alcohol problems, despite having higher rates of abstention than Whites and Hispanics. Hispanics also generally suffer more alcohol-related problems than whites. Overall, injury recidivism is higher among poorer, minority populations and among individuals who abuse alcohol. The efficacy of brief alcohol interventions in the emergency care setting such as hospital emergency departments and trauma care centers is a relatively new area of research. Brief alcohol interventions appear to reduce alcohol intake and rates of injury following hospitalization; however, there is a need to evaluate the efficacy of these brief interventions in various ethnic groups. The proposed research involves a randomized controlled trial of a brief alcohol intervention based upon motivational interviewing and harm reduction to reduce alcohol consumption and injury following admission to an emergency room or trauma department for treatment of an injury. The primary aim of the proposed project is to determine the efficacy of this intervention as applied in the trauma care and emergency room setting among Whites, Blacks and Hispanics. The three outcomes of interest include:
- alcohol consumption as measured by number of standard drinks consumed per week and
- frequency of drinking five or more drinks per occasion engagement in injury related risk behaviors and
- injury recidivism rates
It is hypothesized that the brief alcohol intervention will have a greater impact on alcohol consumption, injury related risk behaviors and injury recidivism among Whites than Blacks and Mexican Americans. In addition, it is hypothesized that the brief alcohol intervention will have less of an impact on alcohol consumption, injury related risk behaviors and injury recidivism among Mexican Americans born in the United States than among those born in Mexico after controlling for acculturation, acculturation stress and sociodemographic characteristics.
- Conditions
- Injuries, Alcohol Related Disorders
- Being tested
- Brief intervention based on motivational interviewing, Standard Care including referral for treatment
- Keywords
- Screening and Brief Intervention, Ethnic Differences, Trauma Center
- Medical subject headings
- Wounds and Injuries, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief intervention based on motivational interviewingBehavioural
The intervention was an approximately 30 minute discussion about alcohol-related risk behaviors and motivation to change
Standard Care including referral for treatmentBehavioural
Standard hospital care provided the patient with information and referral for treatment as necessary.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients randomized to this arm received an intervention based in the motivational interviewing style Receives: Behavioral: Brief intervention based on motivational interviewing |
| 2 | Active comparator | Patients randomized to this arm received standard hospital care Receives: Behavioral: Standard Care including referral for treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
alcohol intake
Measured: six months and one year
injury recidivism
Measured: six months and one year
Secondary outcomes (2)
alcohol problems
Measured: six months and one year
injury related risk behaviors
Measured: 6 months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startMay 2003
- Primary completionAug 2006
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InjuriesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,493 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Raul Caetano, The University of Texas Health Science Center, Houston
- Investigators
- Raul Caetano, MD, PhD, Principal investigator, University of Texas Health Science Center School of Public Health Dallas Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132262
- Sponsor's protocol ID
- R01AA013824
- Status last verified
- Jan 2013
- First submitted
- 16 Aug 2005
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cochran G, Field C, Caetano R. Injury-related consequences of alcohol misuse among injured patients who received screening and brief intervention for alcohol: a latent class analysis. Subst Abus. 2014;35(2):153-62. doi: 10.1080/08897077.2013.820679.
PubMed 24821352Cochran G, Field C, Caetano R. Changes in Classes of Injury-Related Risks and Consequences of Risk-Level Drinking: a Latent Transition Analysis. J Behav Health Serv Res. 2015 Jul;42(3):355-66. doi: 10.1007/s11414-013-9378-3.
PubMed 24259197Field CA, Caetano R, Harris TR, Frankowski R, Roudsari B. Ethnic differences in drinking outcomes following a brief alcohol intervention in the trauma care setting. Addiction. 2010 Jan;105(1):62-73. doi: 10.1111/j.1360-0443.2009.02737.x. Epub 2009 Nov 17.
PubMed 19919597
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention to Reduce Injury in Minorities
- ClinicalTrials.gov ID
- NCT00132262
- Acronym / sponsor ID
- R01AA013824
- Conditions
- Injuries, Alcohol Related Disorders
- Keywords
- Screening and Brief Intervention, Ethnic Differences, Trauma Center
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,493 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- May 2003
- Primary completion
- Aug 2006 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Aug 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 evaluate the effectiveness and ethnic differences of a brief alcohol intervention for injured patients.
Detailed description
Injuries are not isolated events or one time occurrences and injury has been identified as an important public health problem. Among the risk factors associated with injury and injury recidivism, the most widely recognized is alcohol use with approximately 50% of all injuries associated with alcohol. In general, alcohol use and drinking patterns vary by ethnicity, with frequent heavy drinking and associated problems more common among Blacks and Hispanics. Blacks, in general, suffer a disproportionate level of alcohol problems, despite having higher rates of abstention than Whites and Hispanics. Hispanics also generally suffer more alcohol-related problems than whites. Overall, injury recidivism is higher among poorer, minority populations and among individuals who abuse alcohol. The efficacy of brief alcohol interventions in the emergency care setting such as hospital emergency departments and trauma care centers is a relatively new area of research. Brief alcohol interventions appear to reduce alcohol intake and rates of injury following hospitalization; however, there is a need to evaluate the efficacy of these brief interventions in various ethnic groups. The proposed research involves a randomized controlled trial of a brief alcohol intervention based upon motivational interviewing and harm reduction to reduce alcohol consumption and injury following admission to an emergency room or trauma department for treatment of an injury. The primary aim of the proposed project is to determine the efficacy of this intervention as applied in the trauma care and emergency room setting among Whites, Blacks and Hispanics. The three outcomes of interest include:
- alcohol consumption as measured by number of standard drinks consumed per week and
- frequency of drinking five or more drinks per occasion engagement in injury related risk behaviors and
- injury recidivism rates
It is hypothesized that the brief alcohol intervention will have a greater impact on alcohol consumption, injury related risk behaviors and injury recidivism among Whites than Blacks and Mexican Americans. In addition, it is hypothesized that the brief alcohol intervention will have less of an impact on alcohol consumption, injury related risk behaviors and injury recidivism among Mexican Americans born in the United States than among those born in Mexico after controlling for acculturation, acculturation stress and sociodemographic characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Brief intervention based on motivational interviewingPatients randomized to this arm received an intervention based in the motivational interviewing style |
| 2 | Active comparator | Behavioral: Standard Care including referral for treatmentPatients randomized to this arm received standard hospital care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admission for treatment of an injury
- Self identification of Black, White or Hispanic Ethnicity
- Age > 17
- Screen positive for potential alcohol related injury based upon clinical indication of alcohol use prior to injury including positive blood alcohol concentration, self report of alcohol use prior to injury, heavy drinking or drinking beyond normal limits as defined by NIAAA
Key exclusion criteria (2 listed)
- Glasgow Coma Score or GCS < 14
- Admission for self inflicted injury
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 |
|---|---|---|
| Brief intervention based on motivational interviewingThe intervention was an approximately 30 minute discussion about alcohol-related risk behaviors and motivation to change | Behavioural | 1 |
| Standard Care including referral for treatmentStandard hospital care provided the patient with information and referral for treatment as necessary. | Behavioural | 2 |
Primary outcome
alcohol intake
Time frame: six months and one year
injury recidivism
Time frame: six months and one year
2 secondary outcomes
alcohol problems
Time frame: six months and one year
injury related risk behaviors
Time frame: 6 months and one year
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 30 Jan 2013.
- Derived from this study: PubMed 24821352Cochran G, Field C, Caetano R. Injury-related consequences of alcohol misuse among injured patients who received screening and brief intervention for alcohol: a latent class analysis. Subst Abus. 2014;35(2):153-62. doi: 10.1080/08897077.2013.820679.
- Derived from this study: PubMed 24259197Cochran G, Field C, Caetano R. Changes in Classes of Injury-Related Risks and Consequences of Risk-Level Drinking: a Latent Transition Analysis. J Behav Health Serv Res. 2015 Jul;42(3):355-66. doi: 10.1007/s11414-013-9378-3.
- Derived from this study: PubMed 19919597Field CA, Caetano R, Harris TR, Frankowski R, Roudsari B. Ethnic differences in drinking outcomes following a brief alcohol intervention in the trauma care setting. Addiction. 2010 Jan;105(1):62-73. doi: 10.1111/j.1360-0443.2009.02737.x. Epub 2009 Nov 17.
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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.
Raul Caetano, MD, PhD principal investigator
University of Texas Health Science Center School of Public Health Dallas Campus
Questions about this trial
What is this clinical trial studying?
A study testing Brief intervention based on motivational interviewing in people with Injuries and Alcohol Related Disorders, run by The University of Texas Health Science Center, Houston.
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 4 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 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
alcohol intake (time frame: six months and one year). The study lists 2 primary outcomes in all. 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 NCT00132262, which also lists 3 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 30 Jan 2013; AzTrials last refreshed its copy on 6 Nov 2026.