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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA016000 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
This is a 2-year research project to test the efficacy of brief motivational intervention for reducing heavy alcohol use in young adults transitioning out of high school. Participation occurs within 3 months prior to graduation or within 1 year following graduation or dropout from high school. Heavy drinkers ages 17-20 will be randomly assigned to receive one session of BMI or one session of relaxation training. All participants complete identical assessments at baseline and immediately post-intervention (during session 1). Participants also complete in-person 6-week and 3-month follow up assessments to evaluate intervention effects. Study aims involve: a) testing the comparative efficacy of BMI; b) identifying moderators (person-level predictors) of intervention response; and c) identifying mediators (mechanisms) of intervention effects, that is, how BMI exerts its effect on outcomes.
This study tested the efficacy of a single session of BMI for reducing heavy drinking and related adverse consequences among underage young adult drinkers not attending a 4-year college or university. We designed the intervention to be delivered proximal to the transition out of high school (with or without graduation), because such periods of transition and discontinuity in the life course present opportunities to positively alter developmental paths (Masten et al., 2009). Thus, interventions timed to co-occur with naturalistic transition points may have great potential for decreasing drinking trajectories or preventing harmful escalations in trajectories going forward. To increase the applicability of our findings to the heterogeneous population of community-dwelling young adults, our recruitment targeted a purposefully inclusive "non-4-year-college" population. We hypothesized that, compared to a time and attention-matched control condition (i.e., relaxation training [REL]), BMI would result in significantly reduced heavy drinking and reduced adverse consequences of alcohol use at 6-week and 3-month follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relaxation training (REL) | Placebo Comparator | 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. |
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| Brief Motivational Intervention (BMI) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Motivational Counseling | Behavioral | One hour session of brief motivational counseling focused on reduction of heavy drinking. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Timeline Follow Back Assessing Number of Standard Drinks | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Young Adult Alcohol Consequences Questionnaire | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29750362 | Result | Colby SM, Orchowski L, Magill M, Murphy JG, Brazil LA, Apodaca TR, Kahler CW, Barnett NP. Brief Motivational Intervention for Underage Young Adult Drinkers: Results from a Randomized Clinical Trial. Alcohol Clin Exp Res. 2018 Jul;42(7):1342-1351. doi: 10.1111/acer.13770. Epub 2018 Jun 6. |
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168 were consented and enrolled. One person was determined to be ineligible because they were simultaneously participating in another alcohol intervention research study simultaneously. That were person was withdrawn from the study, resulting in a sample of 167 participants.
The study was promoted via posted flyers in the community; advertisements on buses, websites, and in newspapers; and recruitment events at high schools, community colleges, vocational/technical programs, social service agencies, and GED classes. Research staff described the study to groups/classes or at information booths set up in a lobby or cafeteria. Data collection took place in Rhode Island and Southeastern Massachusetts from June 2010 to October 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Relaxation Training | Relaxation training: One hour training in relaxation techniques |
| FG001 | Brief Motivational Counseling | Brief Motivational Counseling: One hour session of brief motivational counseling focused on reduction of heavy drinking. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Relaxation Training | Relaxation training (REL): One hour training in relaxation techniques REL was designed to control for nonspecific therapeutic effects by providing equivalent levels of attention from and rapport with a counselor. REL began with an introduction to the intervention and general rapport building. The counselor asked about the participant's typical experiences with daily stress, and reviewed various strategies the participant had used to cope with stress. Past experiences with meditation and relaxation were explored. To promote positive treatment expectancies, the counselor presented a rationale for the use of REL for alcohol reduction. Participants were told: (i) the transition to adulthood can be stressful, and stress can lead to increased alcohol use; and (ii) alternative approaches to coping with stress, such as meditation and relaxation techniques, can reduce stress and thereby prevent excessive alcohol use. For the remainder of the session, 2 strategies for coping with stress were introduced and practiced: the first was a simple, guided breathing meditation; and the second was a full-body progressive muscle relaxation. Both exercises were scripted and read aloud by the counselor as the participant followed the counselor instructions. The session concluded with a review of the participant's experiences during the 2 exercises and a counselor recommendation to practice the techniques regularly. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Timeline Follow Back Assessing Number of Standard Drinks | This is a calculation of the number of standard alcohol drinks consumed per week, based on data collected via the timeline follow back interview | Posted | Mean | Standard Deviation | standard drinks/week | 3 months |
|
3 months
Any adverse events reports at study contacts were to be recorded in study record.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Relaxation Training | Relaxation training (REL): One hour training in relaxation techniques REL was designed to control for nonspecific therapeutic effects by providing equivalent levels of attention from and rapport with a counselor. REL began with an introduction to the intervention and general rapport building. The counselor asked about the participant's typical experiences with daily stress, and reviewed various strategies the participant had used to cope with stress. Past experiences with meditation and relaxation were explored. To promote positive treatment expectancies, the counselor presented a rationale for the use of REL for alcohol reduction. Participants were told: (i) the transition to adulthood can be stressful, and stress can lead to increased alcohol use; and (ii) alternative approaches to coping with stress, such as meditation and relaxation techniques, can reduce stress and thereby prevent excessive alcohol use. For the remainder of the session, 2 strategies for coping with stress were introduced and practiced: the first was a simple, guided breathing meditation; and the second was a full-body progressive muscle relaxation. Both exercises were scripted and read aloud by the counselor as the participant followed the counselor instructions. The session concluded with a review of the participant's experiences during the 2 exercises and a counselor recommendation to practice the techniques regularly. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzanne Colby | Brown University | 4018636655 | Suzanne_Colby@brown.edu |
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| ID | Term |
|---|---|
| D063425 | Binge Drinking |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D000428 | Alcohol Drinking |
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| ID | Term |
|---|---|
| D012064 | Relaxation Therapy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
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|
| Relaxation training | Behavioral | One hour training in relaxation techniques |
|
|
| 6 week and 3 month follow ups |
| Help Seeking | Count of participants reporting receiving any type of counseling for alcohol in the prior 6 weeks | 6 week and 3 month follow ups |
| Drinking Reduction Strategies | 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 | 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 | 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 |
| Adolescent Reinforcement Survey Schedule (ARSS) | 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 |
| BG001 | Brief Motivational Counseling | Brief Motivational Intervention (BMI) Counseling: One hour session of BMI focused on reduction of heavy drinking. The counselor built rapport while eliciting information about the developmental context of the participant's drinking behavior, discussing current experiences, goals, and plans for the next several years in different domains (education/training, work, financial independence, social transitions, romantic relationships). The counselor explored how alcohol and drinking fit into the participant's life, and how the participant expected their drinking to change into adulthood. Assessing motivation involved exploring the positive and negative aspects of drinking for participants. Enhancing motivation consisted of providing a personalized feedback report including normative feedback, and personalized risk factors and other elements like time and money allocation. Participants were asked to envision themselves in the future if they decided to make a change, and again if they decided not to change. The counselor drew upon participants' goals (e.g., social, recreational, occupational, financial) to highlight discrepancies between drinking behavior and proximal life goals. The participant identified goals for change related to drinking. The BMI reviewed strategies for reducing heavy drinking. Participant strengths, protective factors, and autonomy/ability to make changes were elicited and supported. Throughout the session, counselors used MI principles and techniques. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Avg Number of Standard Drinks per week | This is a calculation of estimated average drinks consumed per week at baseline, using daily data derived from the timeline follow back interview | Mean | Standard Deviation | standard drinks per week |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Brief Young Adult Alcohol Consequences Questionnaire | 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. | This measure is analyzed among participants who reported any alcohol use in the assessment window. | Posted | Mean | Standard Deviation | units on a scale | 6 week and 3 month follow ups |
|
|
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| Secondary | Help Seeking | Count of participants reporting receiving any type of counseling for alcohol in the prior 6 weeks | Participants in each group with data on this variable at 6 week follow up and 3 month follow up | Posted | Count of Participants | Participants | 6 week and 3 month follow ups |
|
|
|
| Secondary | Drinking Reduction Strategies | 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 | Participants in each group with data on this variable at 6 week and 3 month follow up. | Posted | Mean | Standard Deviation | units on a scale | 6 week and 3 month follow ups |
|
|
|
| Secondary | Employment Outcomes | 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. | This includes all participants in each group at 6 week and at 3 month follow up who reported engaging in paid employment in the prior 6 weeks | Posted | Mean | Standard Deviation | units on a scale | 6 week and 3 month follow ups |
|
|
|
| Secondary | Satisfaction With Life | 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. | Participants in each group with valid data on this scale at 6 week or 3 month follow up | Posted | Mean | Standard Deviation | units on a scale | 6 week and 3 month follow ups |
|
|
|
| Secondary | Adolescent Reinforcement Survey Schedule (ARSS) | 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. | Participants in each group with valid data on this variable at 6 week or 3 month follow up. | Posted | Mean | Standard Deviation | percentage of enjoyment due to alcohol | 6 week and 3 month follow ups |
|
|
|
| 0 |
| 84 |
| 0 |
| 84 |
| 0 |
| 84 |
| EG001 | Brief Motivational Counseling | Brief Motivational Intervention (BMI) Counseling: One hour session of BMI focused on reduction of heavy drinking. The counselor built rapport while eliciting information about the developmental context of the participant's drinking behavior, discussing current experiences, goals, and plans for the next several years in different domains (education/training, work, financial independence, social transitions, romantic relationships). The counselor explored how alcohol and drinking fit into the participant's life, and how the participant expected their drinking to change into adulthood. Assessing motivation involved exploring the positive and negative aspects of drinking for participants. Enhancing motivation consisted of providing a personalized feedback report including normative feedback, and personalized risk factors and other elements like time and money allocation. Participants were asked to envision themselves in the future if they decided to make a change, and again if they decided not to change. The counselor drew upon participants' goals (e.g., social, recreational, occupational, financial) to highlight discrepancies between drinking behavior and proximal life goals. The participant identified goals for change related to drinking. The BMI reviewed strategies for reducing heavy drinking. Participant strengths, protective factors, and autonomy/ability to make changes were elicited and supported. Throughout the session, counselors used MI principles and techniques. | 0 | 83 | 0 | 83 | 0 | 83 |
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| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| Drinking reduction score, 3 month follow up |
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| General life satisfaction, 3 monnth follow up |
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| Enjoyment attributed to alcohol, 3 month follow up |
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