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Screening and Brief Intervention in the ED Among Mexican-origin Young Adults

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ClinicalTrials.gov Identifier: NCT02056535
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):
Cheryl Cherpitel, Public Health Institute, California

Brief 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 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.

Condition or disease Intervention/treatment Phase
Problem Drinking Alcohol Dependence Behavioral: Brief Motivational Intervention Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 698 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Screening and Brief Intervention in the ED Among Mexican-origin Young Adults
Study Start Date : May 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
No Intervention: Screened Only
Screened only and met criteria for eligibility for study
No Intervention: Screened and Assessed
Screened as eligible for the study and received baseline assessment
Active Comparator: Intervention
Screened eligible, received baseline assessment and intervention
Behavioral: Brief Motivational Intervention
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Change in Frequency of Drinking [ Time Frame: Baseline, 3 months & 12 months ]
    Change in number of drinking days per week

  2. Change in Alcohol-related problems [ Time Frame: Baseline, 3 months &12 months ]
    Change in Rapid Alcohol Problem Screen score and Short Inventory of Problems related to drinking

  3. Change in Quantity of Drinking [ Time Frame: Baseline, 3 months & 12 months ]
    Change in average number of drinks per week; number of drinks per drinking day; and maximum number of drinks



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

18-30 years old

  1. Self-identify as Mexican-origin
  2. Living in the El Paso area on the U.S. side
  3. 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)
  4. Agree to be randomized to one of three groups
  5. Can supply contact information on at least two individuals who will always know where they are
  6. Not currently being treated for an alcohol problem

Exclusion Criteria:

  • Does not meet inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056535


Locations
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United States, Texas
Texas Tech University Medical Sciences Center, ER
El Paso, Texas, United States
Sponsors and Collaborators
Public Health Institute, California
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cheryl Cherpitel, Senior Scientist, Public Health Institute, California
ClinicalTrials.gov Identifier: NCT02056535    
Other Study ID Numbers: R01AA018119 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: June 2013
Keywords provided by Cheryl Cherpitel, Public Health Institute, California:
Alcohol
SBIRT (Screening, Brief Intervention, Referral to Treatment)
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders