Clinical trial NCT02056535: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Problem Drinking
Alcohol Dependence
Keywords: Alcohol
SBIRT (Screening, Brief Intervention, Referral to Treatment)
Lead sponsor: Public Health Institute, California
Sponsor class: OTHER
First posted: 2014-02-06
Enrollment: 698
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in the number of drinks per week and the number of drinks per drinking day
timeFrame: Baseline, 3 months & 12 months
Secondary outcomes:
measure: Change in Frequency of Drinking
timeFrame: Baseline, 3 months & 12 months
measure: Change in Alcohol-related problems
timeFrame: Baseline, 3 months &12 months
measure: Change in Quantity of Drinking
timeFrame: Baseline, 3 months & 12 months
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Texas Tech University Medical Sciences Center, ER
state: Texas
Study officials:
References:
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.