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

Primary Purpose

Problem Drinking, Alcohol Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brief Motivational Intervention
Sponsored by
Public Health Institute, California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Problem Drinking focused on measuring Alcohol, SBIRT (Screening, Brief Intervention, Referral to Treatment)

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Texas Tech University Medical Sciences Center, ER

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Active Comparator

Arm Label

Screened Only

Screened and Assessed

Intervention

Arm Description

Screened only and met criteria for eligibility for study

Screened as eligible for the study and received baseline assessment

Screened eligible, received baseline assessment and intervention

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change in Frequency of Drinking
Change in number of drinking days per week
Change in Alcohol-related problems
Change in Rapid Alcohol Problem Screen score and Short Inventory of Problems related to drinking
Change in Quantity of Drinking
Change in average number of drinks per week; number of drinks per drinking day; and maximum number of drinks

Full Information

First Posted
June 4, 2013
Last Updated
February 4, 2014
Sponsor
Public Health Institute, California
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1. Study Identification

Unique Protocol Identification Number
NCT02056535
Brief Title
Screening and Brief Intervention in the ED Among Mexican-origin Young Adults
Official Title
Screening and Brief Intervention in the ED Among Mexican-origin Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Public Health Institute, California

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Problem Drinking, Alcohol Dependence
Keywords
Alcohol, SBIRT (Screening, Brief Intervention, Referral to Treatment)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
698 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Screened Only
Arm Type
No Intervention
Arm Description
Screened only and met criteria for eligibility for study
Arm Title
Screened and Assessed
Arm Type
No Intervention
Arm Description
Screened as eligible for the study and received baseline assessment
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Screened eligible, received baseline assessment and intervention
Intervention Type
Behavioral
Intervention Name(s)
Brief Motivational Intervention
Intervention Description
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 Measure Information:
Title
Change in the number of drinks per week and the number of drinks per drinking day
Description
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)
Time Frame
Baseline, 3 months & 12 months
Secondary Outcome Measure Information:
Title
Change in Frequency of Drinking
Description
Change in number of drinking days per week
Time Frame
Baseline, 3 months & 12 months
Title
Change in Alcohol-related problems
Description
Change in Rapid Alcohol Problem Screen score and Short Inventory of Problems related to drinking
Time Frame
Baseline, 3 months &12 months
Title
Change in Quantity of Drinking
Description
Change in average number of drinks per week; number of drinks per drinking day; and maximum number of drinks
Time Frame
Baseline, 3 months & 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Does not meet inclusion criteria
Facility Information:
Facility Name
Texas Tech University Medical Sciences Center, ER
City
El Paso
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26243733
Citation
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.
Results Reference
derived

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

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