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

Alcohol Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056535
• Other study ID #: R01AA018119
• Status: Completed
• Phase: Phase 2
• First received: June 4, 2013
• Last updated: February 4, 2014
• Start date: May 2010
• Est. completion date: October 2013

Study information

• Verified date: June 2013
• Source: Public Health Institute, California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 698
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Problem Drinking

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.

Locations

Country	Name	City	State
United States	Texas Tech University Medical Sciences Center, ER	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Public Health Institute, California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline, 3 months & 12 months	No
Secondary	Change in Frequency of Drinking	Change in number of drinking days per week	Baseline, 3 months & 12 months	No
Secondary	Change in Alcohol-related problems	Change in Rapid Alcohol Problem Screen score and Short Inventory of Problems related to drinking	Baseline, 3 months &12 months	No
Secondary	Change in Quantity of Drinking	Change in average number of drinks per week; number of drinks per drinking day; and maximum number of drinks	Baseline, 3 months & 12 months	No