- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01546025
Brief Alcohol Intervention for School-to-Work Transitions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- high school students anticipating graduation within 3 months, drop outs or graduates
- males must report at least one day drinking 5 or more standard drinks in past month
- females must report at least one day drinking 4 or more standard drinks in past month
Exclusion Criteria:
- plans to enroll at traditional 4-year college within 12 months
- plans to enter military within next 12 months
- plans to move more than 1 hour from current location in within 12 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Relaxation training (REL)
This was a 1-hr behavioral counseling session designed to control for nonspecific therapeutic effects by providing equivalent levels of attention from and rapport with a counselor.
It began with an introduction and rapport building.
The counselor asked about the participant's daily stress level and strategies used to cope.
Experience with meditation and relaxation were explored.
The counselor presented a rationale for the use of REL for alcohol reduction, namely: the transition to adulthood can be stressful, and stress can lead to increased alcohol use; meditation and relaxation can reduce stress and thereby prevent excessive alcohol use.
Didactic information about mental and physical stress and coping was provided.
Two strategies were practiced: a simple, guided breathing meditation and a full-body progressive muscle relaxation.
The session concluded with a review of the participant's experiences during the 2 exercises and a recommendation to practice the techniques regularly.
|
One hour training in relaxation techniques
Other Names:
|
|
Active Comparator: Brief Motivational Intervention (BMI)
This is a 1-hr motivational intervention session.
The counselor built rapport while eliciting information about the participant's drinking, discussing current experiences, goals and plans in different domains (education, work, financial independence, social transitions, relationships).
The counselor explored how drinking fit into the participant's life and explored risk and protective factors.
The session involved: Assessing motivation; Enhancing motivation; Personalized feedback; Envisioning the future with/without change; Counselor summary; and Optional personalized change plan.
Participant strengths, protective factors, and autonomy/ability to make changes were elicited and supported.
Counselors used MI principles and techniques, including using open-ended questions, reflective listening, eliciting change talk, and supporting self-efficacy statements.
|
One hour session of brief motivational counseling focused on reduction of heavy drinking.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timeline Follow Back Assessing Number of Standard Drinks
Time Frame: 3 months
|
This is a calculation of the number of standard alcohol drinks consumed per week, based on data collected via the timeline follow back interview
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brief Young Adult Alcohol Consequences Questionnaire
Time Frame: 6 week and 3 month follow ups
|
Measure of problem severity in young adult drinkers.
Respondents indicated on the Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ; Kahler et al., 2005) whether they had experienced each of 24 adverse alcohol-related consequences in the prior 6 weeks; items are summed for a total score (Cronbach's α = 0.81 at BL), with a minimum score of 0 and a maximum score of 24.
Higher scores indicate worse outcome.
|
6 week and 3 month follow ups
|
|
Drinking Reduction Strategies
Time Frame: 6 week and 3 month follow ups
|
Total score on the Strategies to Limit Drinking 31-item scale.
Likert response for each item ranges from 1 = never to 5 = always; range = 31 to 155; higher scores indicate better outcomes: higher scores reflect greater frequency of using various strategies to deliberately limit one's drinking over the past 6 weeks
|
6 week and 3 month follow ups
|
|
Employment Outcomes
Time Frame: 6 week and 3 month follow ups
|
Mean score on the "Your Workplace" questionnaire: Negative Effects on Work Performance subscale. Range = 0 to 5. Response options for each item on the subscale are 0 = never; 1 = once or twice, 2 = about once every 2 weeks, 3 = about once a week, 4 = 2-4 times a week, 5 = about daily. Higher scores indicate worse outcomes: Higher scores reflect more frequent negative effects of alcohol use on work performance in the past 6 weeks. |
6 week and 3 month follow ups
|
|
Satisfaction With Life
Time Frame: 6 week and 3 month follow ups
|
This is a mean score on the Satisfaction With Life Scale (SWLS), a 5-item instrument designed to measure global cognitive judgments of life satisfaction, using a 7-point Likert scale (1=strongly disagree to 7=strongly agree), with higher scores indicating better outcomes, i.e., higher scores indicate greater life satisfaction at the time of assessment.
Range = 1 to 7.
|
6 week and 3 month follow ups
|
|
Help Seeking
Time Frame: 6 week and 3 month follow ups
|
Count of participants reporting receiving any type of counseling for alcohol in the prior 6 weeks
|
6 week and 3 month follow ups
|
|
Adolescent Reinforcement Survey Schedule (ARSS)
Time Frame: 6 week and 3 month follow ups
|
The ARSS contains a list of 45 rewarding activities.
Participants rate the frequency with which they participate in each activity WITH and then WITHOUT alcohol/drug use, and then rate their enjoyment of each activity WITH and WITHOUT alcohol/drug use.
The outcome measure represents the percentage of reinforcement participants get (i.e., the cross product of frequency X enjoyment) from activities involving alcohol/drug use divided by the total reinforcement they get from all activities with or without alcohol/drug use.
Range = 0 to 100; higher scores indicate worse outcomes, i.e., higher scores reflect a greater percentage of enjoyable activities involving alcohol and/or use.
|
6 week and 3 month follow ups
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AA016000 (U.S. NIH Grant/Contract)
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