Project U Connect - Optimizing Brief Alcohol Intervention for Underage Drinkers in the ER

Study Overview
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Brief Summary
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The Emergency Department (ED) setting is a unique point of access for reaching underage drinkers (age 14-20). With the aid of computer technology, this study will screen underage drinkers in the ED and fully test promising ED-based brief intervention and 3-month follow-up brief treatment approaches for alcohol misuse. Developing methods to efficiently and effectively optimize these approaches has powerful public health implications for improving outcomes for underage drinkers.

Detailed Description
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The proposed study will use computerized screening using touchscreen computer tablets with audio ( 5,700 patients) and will test a developmentally appropriate, tailored intervention. Specifically, 900 patients aged 14-20 in the ED who screen positive for problematic alcohol use in the past 3 months will be randomized to the combinations of three ED-based conditions: 1) computer brief intervention-CBI; 2) therapist/intervener delivered brief intervention-IBI; or 3) enhanced usual care-EUC. All participants will be randomized to one of two follow-up conditions: 1) adapted motivational enhancement therapy-AMET; or 2) enhanced usual care-EUC that will take place 3 months post-ED. All participants will receive written information regarding community resources; individuals who meet alcohol use disorder criteria will additionally receive substance use treatment referrals. Recognizing that brief interventions are important, but not necessarily sufficient, for change in all adolescents and young adults who misuse alcohol, the primary specific aims of the proposed study will determine the independent effectiveness of immediate on-the-spot ED-based brief intervention conditions, 3-month follow-up brief treatment conditions, and combinations of conditions, for decreasing alcohol use and improving health-related outcomes (including injury, mental health, and other risk behaviors) at 6- and 12-months follow-up.

Official Title
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Optimizing Brief Alcohol Intervention for Underage Drinkers in the ER

Conditions
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Alcohol Misuse

Intervention / Treatment
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* Behavioral: Computer-delivered Brief Intervention (CBI)
* Behavioral: Intervener-delivered Brief Intervention (IBI)
* Behavioral: Adapted Motivational Enhancement Therapy (AMET)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria for screening: (1) Patients age 14-20 years presenting to the UMMC ED for medical care (2) ability to provide informed consent. Additional inclusion criteria for intervention based on alcohol misuse: Participants screening positive on the AUDIT for problematic alcohol use in the past 3 months will be eligible for the randomized control trial. Exclusion Criteria: (1) patients who do not understand English (2) patients deemed unable to provide informed consent (e.g., mental incompetence, prisoners); (3) adolescents ages 14-17 presenting without a parent/guardian; and (4) patients treated in the ED for suicide attempts or sexual assault.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBI in ED with AMET at 3 months<br>computer brief intervention (CBI) at baseline with adapted motivational enhancement therapy-AMET at 3 months | Behavioral: Computer-delivered Brief Intervention (CBI)<br>* The multimedia, interactive CBI condition will be delivered using touch-screen tablet computers with audio delivered via headphones. The interventions are highly individualized and designed to address the primary target behavior of alcohol use, and will include a tailored review of participants' goals/values, feedback regarding their present alcohol use patterns and consequences (either actual experiences or potential based on risk behaviors), developing a discrepancy between their alcohol use and ability to meet goals and values through a decisional balance exercise, and formulation of a change plan tailored for each participant.<br>Behavioral: Adapted Motivational Enhancement Therapy (AMET)<br>* The AMET session will have a similar general outline ( 45 minutes) to the BI in the ED, including a review of participants' goals and values, alcohol use and consequences, decisional balance exercises, and change plan.<br>|
| Active Comparator: CBI in ED with EUC at 3 months<br> | Behavioral: Computer-delivered Brief Intervention (CBI)<br>* The multimedia, interactive CBI condition will be delivered using touch-screen tablet computers with audio delivered via headphones. The interventions are highly individualized and designed to address the primary target behavior of alcohol use, and will include a tailored review of participants' goals/values, feedback regarding their present alcohol use patterns and consequences (either actual experiences or potential based on risk behaviors), developing a discrepancy between their alcohol use and ability to meet goals and values through a decisional balance exercise, and formulation of a change plan tailored for each participant.<br>|
| Active Comparator: IBI in ED with AMET at 3 months<br> | Behavioral: Intervener-delivered Brief Intervention (IBI)<br>* The IBI condition will be delivered by a master's-level clinician with the aid of graphics. The interventions are highly individualized and designed to address the primary target behavior of alcohol use, and will include a tailored review of participants' goals/values, feedback regarding their present alcohol use patterns and consequences (either actual experiences or potential based on risk behaviors), developing a discrepancy between their alcohol use and ability to meet goals and values through a decisional balance exercise, and formulation of a change plan tailored for each participant.<br>Behavioral: Adapted Motivational Enhancement Therapy (AMET)<br>* The AMET session will have a similar general outline ( 45 minutes) to the BI in the ED, including a review of participants' goals and values, alcohol use and consequences, decisional balance exercises, and change plan.<br>|
| Active Comparator: IBI in ED with EUC at 3 months<br> | Behavioral: Intervener-delivered Brief Intervention (IBI)<br>* The IBI condition will be delivered by a master's-level clinician with the aid of graphics. The interventions are highly individualized and designed to address the primary target behavior of alcohol use, and will include a tailored review of participants' goals/values, feedback regarding their present alcohol use patterns and consequences (either actual experiences or potential based on risk behaviors), developing a discrepancy between their alcohol use and ability to meet goals and values through a decisional balance exercise, and formulation of a change plan tailored for each participant.<br>|
| Active Comparator: EUC in ED with AMET at 3 months<br> | Behavioral: Adapted Motivational Enhancement Therapy (AMET)<br>* The AMET session will have a similar general outline ( 45 minutes) to the BI in the ED, including a review of participants' goals and values, alcohol use and consequences, decisional balance exercises, and change plan.<br>|
| No Intervention: EUC in ED with EUC at 3 months<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| alcohol use, alcohol related consequences |  | 3 -12 month period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health-related outcomes (injury, mental health, illicit and psychoactive prescription drug use/consequences, and other risk behaviors) |  | 3-12 month period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brief intervention, risk behaviors, alcohol use