Problem DrinkingPhase 2NCT02056535
Screening and Brief Intervention in the ED Among Mexican-origin Young Adults
A Phase 2 study testing Brief Motivational Intervention in people with Problem Drinking and Alcohol Dependence, run by Public Health Institute, California at 1 site in United States.
Trial summary
The aims of this study are to: 1) examine the effectiveness of Screening, Brief Intervention and Referral to Treatment (SBIRT) among Mexican-origin young adults (age 18-25), using a motivational intervention delivered by a Health Promotion Advocate, relative to standard care with and without assessment, on a reduction… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Problem Drinking, Alcohol Dependence
- What is being tested?
- Brief Motivational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 698 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Oct 2013
- Phase
- Phase 2
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-30 years old
- Self-identify as Mexican-origin
- Living in the El Paso area on the U.S. side
- Screen positive for at-risk or dependent drinking (positive on one or more of the four RAPS4 items during the last year, or reports 15 or more drinks per week for males (8 or more for females), or reports 5 or more drinks on an occasion for males (4 or more for females)
- Agree to be randomized to one of three groups
- Can supply contact information on at least two individuals who will always know where they are
- Not currently being treated for an alcohol problem
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Medical Sciences Center, ER
El Paso, Texas
About this study
The aims of this study are to: 1) examine the effectiveness of Screening, Brief Intervention and Referral to Treatment (SBIRT) among Mexican-origin young adults (age 18-25), using a motivational intervention delivered by a Health Promotion Advocate, relative to standard care with and without assessment, on a reduction in heavy drinking and alcohol-related problems in the emergency department (ED) at the U.S.-Mexico border; and, 2) identify variables that are related to effectiveness of the intervention and that predict successful treatment outcome. Patients will be re-assessed by telephone at three and twelve months to evaluate outcomes.The specific hypotheses to be examined in this proposal are: 1) the motivational interview will lead to significantly greater reductions in the maximum number of drinks on an occasion and in Rapid Alcohol Problem Screen (RAPS4) score at the 12-month follow-up compared to standard care without assessment (those who screen positive but are not assessed) as well as compared to standard care with assessment; 2) the motivational interview will lead to significantly greater reductions in number of drinking days per week, average number of drinks per day, maximum number of drinks on an occasion, RAPS4 score, and number of negative consequences of drinking at 3-month and 12-month follow-up compared to standard care with assessment; 3) a positive breath alcohol concentration (BAC) at the time of the ED visit and/or self-reported drinking prior to the event resulting in the ED visit will be positively predictive of effectiveness of the intervention; 4) attributing a causal association of drinking and the reason for the ED visit will be positively associated with effectiveness of brief intervention; 5) readiness to change (and stage of change) will be positively associated with effectiveness of brief intervention; 6) risk taking/impulsivity and sensation seeking dispositions will be negatively associated with effectiveness of brief intervention.
Read the detailed description
This is a randomized controlled brief intervention trial for dependent and at-risk drinking, among Mexican origin young adults (18-30) admitted to Texas Tech Health Sciences Center ER in El Paso, Texas, using Screening, Brief Intervention and Referral to Treatment (SBIRT) Patients are randomized into one of three groups: 1) screened only, 2) screened plus assessment, 3) screened plus assessment plus intervention with three-month outcome follow-up for the assessed and intervention groups and 12-month outcome follow-up for all three groups.
- Conditions
- Problem Drinking, Alcohol Dependence
- Being tested
- Brief Motivational Intervention
- Keywords
- Alcohol, SBIRT (Screening, Brief Intervention, Referral to Treatment)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational InterventionBehavioural
A short discussion is held with patients identifying pros and cons of their drinking, readiness for change is assessed, and a brief prescription drawn for behavior change signed by the patient.
| Study group | Role | What they receive |
|---|---|---|
| Screened Only | No intervention | Screened only and met criteria for eligibility for study |
| Screened and Assessed | No intervention | Screened as eligible for the study and received baseline assessment |
| Intervention | Active comparator | Screened eligible, received baseline assessment and intervention Receives: Behavioral: Brief Motivational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of drinks per week and the number of drinks per drinking day
Change to less than 15 or more drinks per week for males (8 or more per week for females), and 5 or more drinks on occasion for males (4 or more for females)
Measured: Baseline, 3 months & 12 months
Secondary outcomes (3)
Change in Frequency of Drinking
Change in number of drinking days per week
Measured: Baseline, 3 months & 12 months
Change in Alcohol-related problems
Change in Rapid Alcohol Problem Screen score and Short Inventory of Problems related to drinking
Measured: Baseline, 3 months &12 months
Change in Quantity of Drinking
Change in average number of drinks per week; number of drinks per drinking day; and maximum number of drinks
Measured: Baseline, 3 months & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startMay 2010
- Primary completionOct 2013
- Study completionOct 2013
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 Problem DrinkingStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 698 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Institute, California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheryl Cherpitel, Public Health Institute, California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056535
- Sponsor's protocol ID
- R01AA018119
- Status last verified
- Jun 2013
- First submitted
- 4 Jun 2013
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cherpitel CJ, Ye Y, Bond J, Woolard R, Villalobos S, Bernstein J, Bernstein E, Ramos R. Brief Intervention in the Emergency Department Among Mexican-Origin Young Adults at the US-Mexico Border: Outcomes of a Randomized Controlled Clinical Trial Using Promotores. Alcohol Alcohol. 2016 Mar;51(2):154-63. doi: 10.1093/alcalc/agv084. Epub 2015 Aug 4.
PubMed 26243733
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Brief Intervention in the ED Among Mexican-origin Young Adults
- ClinicalTrials.gov ID
- NCT02056535
- Acronym / sponsor ID
- R01AA018119
- Conditions
- Problem Drinking, Alcohol Dependence
- Keywords
- Alcohol, SBIRT (Screening, Brief Intervention, Referral to Treatment)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 698 participants (actual)
- Lead sponsor
- Public Health Institute, CaliforniaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 6 Feb 2014 (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 aims of this study are to: 1) examine the effectiveness of Screening, Brief Intervention and Referral to Treatment (SBIRT) among Mexican-origin young adults (age 18-25), using a motivational intervention delivered by a Health Promotion Advocate, relative to standard care with and without assessment, on a reduction in heavy drinking and alcohol-related problems in the emergency department (ED) at the U.S.-Mexico border; and, 2) identify variables that are related to effectiveness of the intervention and that predict successful treatment outcome. Patients will be re-assessed by telephone at three and twelve months to evaluate outcomes.The specific hypotheses to be examined in this proposal are: 1) the motivational interview will lead to significantly greater reductions in the maximum number of drinks on an occasion and in Rapid Alcohol Problem Screen (RAPS4) score at the 12-month follow-up compared to standard care without assessment (those who screen positive but are not assessed) as well as compared to standard care with assessment; 2) the motivational interview will lead to significantly greater reductions in number of drinking days per week, average number of drinks per day, maximum number of drinks on an occasion, RAPS4 score, and number of negative consequences of drinking at 3-month and 12-month follow-up compared to standard care with assessment; 3) a positive breath alcohol concentration (BAC) at the time of the ED visit and/or self-reported drinking prior to the event resulting in the ED visit will be positively predictive of effectiveness of the intervention; 4) attributing a causal association of drinking and the reason for the ED visit will be positively associated with effectiveness of brief intervention; 5) readiness to change (and stage of change) will be positively associated with effectiveness of brief intervention; 6) risk taking/impulsivity and sensation seeking dispositions will be negatively associated with effectiveness of brief intervention.
Detailed description
This is a randomized controlled brief intervention trial for dependent and at-risk drinking, among Mexican origin young adults (18-30) admitted to Texas Tech Health Sciences Center ER in El Paso, Texas, using Screening, Brief Intervention and Referral to Treatment (SBIRT) Patients are randomized into one of three groups: 1) screened only, 2) screened plus assessment, 3) screened plus assessment plus intervention with three-month outcome follow-up for the assessed and intervention groups and 12-month outcome follow-up for all three groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Screened Only | No intervention | –Screened only and met criteria for eligibility for study |
| Screened and Assessed | No intervention | –Screened as eligible for the study and received baseline assessment |
| Intervention | Active comparator | Behavioral: Brief Motivational InterventionScreened eligible, received baseline assessment and intervention |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-30 years old
- Self-identify as Mexican-origin
- Living in the El Paso area on the U.S. side
- Screen positive for at-risk or dependent drinking (positive on one or more of the four RAPS4 items during the last year, or reports 15 or more drinks per week for males (8 or more for females), or reports 5 or more drinks on an occasion for males (4 or more for females)
- Agree to be randomized to one of three groups
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
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 Motivational InterventionA short discussion is held with patients identifying pros and cons of their drinking, readiness for change is assessed, and a brief prescription drawn for behavior change signed by the patient. | Behavioural | Intervention |
Primary outcome
Change in the number of drinks per week and the number of drinks per drinking day
Time frame: Baseline, 3 months & 12 months
Change to less than 15 or more drinks per week for males (8 or more per week for females), and 5 or more drinks on occasion for males (4 or more for females)
3 secondary outcomes
Change in Frequency of Drinking
Time frame: Baseline, 3 months & 12 months
Change in Alcohol-related problems
Time frame: Baseline, 3 months &12 months
Change in Quantity of Drinking
Time frame: Baseline, 3 months & 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 6 Feb 2014.
- Derived from this study: PubMed 26243733Cherpitel CJ, Ye Y, Bond J, Woolard R, Villalobos S, Bernstein J, Bernstein E, Ramos R. Brief Intervention in the Emergency Department Among Mexican-Origin Young Adults at the US-Mexico Border: Outcomes of a Randomized Controlled Clinical Trial Using Promotores. Alcohol Alcohol. 2016 Mar;51(2):154-63. doi: 10.1093/alcalc/agv084. Epub 2015 Aug 4.
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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 Phase 2 study testing Brief Motivational Intervention in people with Problem Drinking and Alcohol Dependence, run by Public Health Institute, California 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 7 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 6 Feb 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in the number of drinks per week and the number of drinks per drinking day (time frame: Baseline, 3 months & 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 NCT02056535, 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 6 Feb 2014.