NCT02056535

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
698

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 6, 2014

Completed
Last Updated

February 6, 2014

Status Verified

June 1, 2013

Enrollment Period

3.4 years

First QC Date

June 4, 2013

Last Update Submit

February 4, 2014

Conditions

Keywords

AlcoholSBIRT (Screening, Brief Intervention, Referral to Treatment)

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Change in Frequency of Drinking

    Baseline, 3 months & 12 months

  • Change in Alcohol-related problems

    Baseline, 3 months &12 months

  • Change in Quantity of Drinking

    Baseline, 3 months & 12 months

Study Arms (3)

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

Behavioral: Brief Motivational Intervention

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University Medical Sciences Center, ER

El Paso, Texas, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

June 4, 2013

First Posted

February 6, 2014

Study Start

May 1, 2010

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

February 6, 2014

Record last verified: 2013-06

Locations