Alcohol Screening, Brief Intervention, and Referral to Treatment in a Military Treatment Facility

Sponsor
San Diego State University (Other)
Overall Status
Completed
CT.gov ID
NCT02228967
Collaborator
United States Naval Medical Center, San Diego (U.S. Fed)
791
1
2
36
22

Study Details

Study Description

Brief Summary

An alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) approach will be adapted for use in a large military hospital setting, and then pilot tested in a military emergency department (ED) to assess its potential for effectiveness and for further testing in a large-scale trial. SBIRT is an "opportunistic" approach whereby all adult patients in the ED are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.

The feasibility/formative research activities in the first phase (Phase I) of the study are not summative research, and therefore, do not lend themselves to testable hypotheses.

Hypotheses with regard to the pilot randomized trial in Phase II are as follows:
  1. Participants in the SBIRT intervention will show relatively greater reductions over a six month period (or less increase) than the brochure/usual care control group in the prevalence of past-month heavy drinking, frequency of heavy drinking, past week number of drinks, and the AUDIT-based drinkers' index.

  2. Alcohol use-related motivation/readiness to change and controlled drinking self-efficacy will show greater change in the SBIRT intervention group relative to the brochure/usual care control group.

In addition, exploratory analyses will examine the following:
  1. Sociodemographic/military variables (e.g., age, race/ethnicity, gender, branch of service, officer/enlisted status, PTS) and social-psychological factors (e.g., baseline readiness to change, self efficacy) will mediate or moderate changes in alcohol misuse.
Condition or Disease Intervention/Treatment Phase
  • Behavioral: SBIRT
N/A

Detailed Description

Deployment frequency and duration and combat exposure are implicated as risk factors for alcohol misuse and PTSD among military personnel. During the past 10 years, Department of Defense healthcare systems have observed steep increases in mental health and substance use services among personnel demobilizing from these conflicts. Although the alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) approach has shown promise as a low-cost, effective strategy for reducing alcohol use in civilians many of whom are risky drinkers but not yet dependent, it has not been adapted or tested in military health care settings for active duty personnel. This 2.5 year civilian-military collaborative study is highly responsive to exploring solutions to this emerging issue. The specific objectives for the overall project are given below.

Objective 1: Feasibility and Acceptability

  • Determine how the SBIRT intervention can be integrated into standard military emergency department (ED) operations by conducting record review and observation of the ED.

  • Develop and test the acceptability and usability (for both ED staff and potential participants) of the SBIRT approach by conducting focus groups with active duty personnel and garnering input from ED staff.

  • Develop an implementation/operations protocol for delivering SBIRT in the ED.

Objective 2: Adaptation

  • Apply a translational research approach to adapt SBIRT implementation in military settings and populations by using information from focus groups and input from ED staff.

  • Adapt the content of the SBIRT intervention to be relevant for military personnel, including language and images for counseling and materials using information from focus groups and input from ED staff.

Objective 3: Pilot Trial

  • Using a two group repeated measures design, assess the impact of SBIRT using standardized alcohol use measures to assess its potential for effectiveness with active duty military personnel in an ED setting. Specific methodologies include:

  • Apply a randomization method in the ED to assign active duty participants to experimental condition.

  • Implement the SBIRT intervention in the ED for those assigned to the intervention arm.

  • Implement a process for obtaining follow-up data with this mobile population.

  • Assess presumed mediators (e.g., readiness/motivation to change and self-efficacy) and moderators (e.g., PTSD status, gender) of alcohol misuse change.

Study Design

Study Type:
Interventional
Actual Enrollment :
791 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Feasibility and Pilot Testing of SBI to Reduce Alcohol Misuse Among Active Duty Members in a Military ER Setting
Actual Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Aug 1, 2018

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Usual Care

Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.

Active Comparator: SBIRT

Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.

Behavioral: SBIRT
SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
Other Names:
  • Screening
  • Brief Intervention
  • Brief Treatment
  • Referral to Treatment
  • Motivational Interviewing
  • Outcome Measures

    Primary Outcome Measures

    1. Alcohol Use Disorders Identification Test (AUDIT) Total [Baseline, Follow-up (Up to 7 months)]

      The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.

    Secondary Outcome Measures

    1. AUDIT-C or Drinkers Index [Baseline, Follow-up (Up to 7 months)]

      The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.

    2. Controlled Drinking Self-Efficacy Scale (CDSES) [Baseline, Follow-up (Up to 7 months)]

      The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.

    3. Readiness to Change Scale [Baseline, Follow-up (Up to 7 months)]

      A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 18 or Older

    • Active Duty

    • Off Duty

    • Telephone Number for Follow-up

    • Healthy Enough to Participate

    • Positive Screen for Risky Drinking

    Exclusion Criteria:
    • Under 18

    • Non-Military

    • On Duty

    • Low Level Drinking

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Naval Medical Center San Diego San Diego California United States 92134

    Sponsors and Collaborators

    • San Diego State University
    • United States Naval Medical Center, San Diego

    Investigators

    • Principal Investigator: Mark Reed, PhD, SDSURF - Center for Alcohol & Drug Studies & Services
    • Principal Investigator: Gerard DeMers, DO, United States Naval Medical Center, San Diego

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mark Reed, PhD, Director, San Diego State University
    ClinicalTrials.gov Identifier:
    NCT02228967
    Other Study ID Numbers:
    • W81XWH-14-2-0014
    • 12019006
    First Posted:
    Aug 29, 2014
    Last Update Posted:
    Sep 9, 2020
    Last Verified:
    Aug 1, 2020
    Keywords provided by Mark Reed, PhD, Director, San Diego State University
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Period Title: Overall Study
    STARTED 403 388
    COMPLETED 244 228
    NOT COMPLETED 159 160

    Baseline Characteristics

    Arm/Group Title Usual Care SBIRT Total
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk. Total of all reporting groups
    Overall Participants 403 388 791
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    26.4
    (6)
    26.3
    (5.7)
    26.3
    (5.9)
    Sex: Female, Male (Count of Participants)
    Female
    103
    25.6%
    108
    27.8%
    211
    26.7%
    Male
    300
    74.4%
    280
    72.2%
    580
    73.3%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic/Latino
    85
    21.1%
    64
    16.5%
    149
    18.8%
    African-American
    74
    18.4%
    71
    18.3%
    145
    18.3%
    White
    215
    53.3%
    214
    55.2%
    429
    54.2%
    Asian/Hawaiian/Pacific Islander
    10
    2.5%
    15
    3.9%
    25
    3.2%
    American Indian/Alaskan Native
    4
    1%
    2
    0.5%
    6
    0.8%
    Other
    15
    3.7%
    22
    5.7%
    37
    4.7%
    Region of Enrollment (participants) [Number]
    United States
    403
    100%
    388
    100%
    791
    100%
    Self-Reported PTSD Diagnosis (Count of Participants)
    Yes
    16
    4%
    21
    5.4%
    37
    4.7%
    No
    387
    96%
    367
    94.6%
    754
    95.3%
    Marital Status (Count of Participants)
    Single
    203
    50.4%
    185
    47.7%
    388
    49.1%
    Married/Co-habitating
    161
    40%
    173
    44.6%
    334
    42.2%
    Divorced/Separated/Widowed
    39
    9.7%
    30
    7.7%
    69
    8.7%
    Education Level (Count of Participants)
    High School Graduate/GED
    169
    41.9%
    149
    38.4%
    318
    40.2%
    Some College
    123
    30.5%
    128
    33%
    251
    31.7%
    2-Year College Degree (AA)
    52
    12.9%
    43
    11.1%
    95
    12%
    4-Year Degree (BA/BS)
    46
    11.4%
    50
    12.9%
    96
    12.1%
    Graduate Degree
    13
    3.2%
    18
    4.6%
    31
    3.9%
    Service Branch (Count of Participants)
    Navy
    336
    83.4%
    320
    82.5%
    656
    82.9%
    Marine Corps
    57
    14.1%
    54
    13.9%
    111
    14%
    Army/Air Force/Coast Guard
    9
    2.2%
    14
    3.6%
    23
    2.9%
    Missing
    1
    0.2%
    0
    0%
    1
    0.1%
    Number of Combat Deployments (past 5-years) (Count of Participants)
    None
    211
    52.4%
    214
    55.2%
    425
    53.7%
    1-2
    173
    42.9%
    148
    38.1%
    321
    40.6%
    3 or more
    19
    4.7%
    25
    6.4%
    44
    5.6%
    Missing
    0
    0%
    1
    0.3%
    1
    0.1%
    Alcohol Use Disorders Identification Test (AUDIT) Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    7.7
    (4.2)
    8.0
    (5.1)
    7.7
    (4.6)
    Readiness to Change Drinking (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    1.95
    (1.17)
    1.96
    (1.15)
    1.96
    (1.16)
    Controlled Drinking Self-Efficacy Scale (CDSES) (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    76.9
    (15.3)
    78
    (15)
    77.9
    (15.2)

    Outcome Measures

    1. Primary Outcome
    Title Alcohol Use Disorders Identification Test (AUDIT) Total
    Description The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    Excludes low-risk participants defined as AUDIT <=7 at baseline. A total of 17 participants were excluded from the analysis.
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 240 215
    Mean (Standard Error) [units on a scale]
    5.91
    (0.26)
    5.5
    (0.27)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value =0.274
    Comments A priori threshold for statistical significance was 0.05
    Method Repeated Measures--General Linear Model
    Comments
    2. Secondary Outcome
    Title AUDIT-C or Drinkers Index
    Description The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    Excludes low-risk participants defined as AUDIT <=7 at baseline. A total of 17 participants were excluded from the analysis.
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 240 215
    Mean (Standard Error) [units on a scale]
    4.41
    (0.14)
    4.05
    (0.15)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value =0.083
    Comments
    Method Repeated Measures--General Linear Model
    Comments
    3. Secondary Outcome
    Title Controlled Drinking Self-Efficacy Scale (CDSES)
    Description The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    Excludes low-risk participants defined as AUDIT <=7 at baseline. A total of 17 participants were excluded from the analysis.
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 240 215
    Mean (Standard Error) [units on a scale]
    78.42
    (1.01)
    81.67
    (1.07)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value =0.028
    Comments
    Method Repeated Measures--General Linear Model
    Comments
    4. Secondary Outcome
    Title Readiness to Change Scale
    Description A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    Excludes low-risk participants defined as AUDIT <=7 at baseline. A total of 17 participants were excluded from the analysis as they were low-risk at baseline. Additionally, missing data on the Readiness to Change measure resulted in a total of 444 participants for this analysis. Six were missing from usual care and five were missing from SBIRT.
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 234 210
    Mean (Standard Error) [units on a scale]
    2.23
    (0.08)
    2.19
    (0.09)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value =0.708
    Comments
    Method Repeated Measures--General Linear Model
    Comments
    5. Post-Hoc Outcome
    Title Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis II)
    Description The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    For this study, at-risk drinking was defined as: AUDIT total >=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 > 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 100 90
    Mean (Standard Error) [units on a scale]
    8.2
    (0.47)
    7.31
    (0.34)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments Data were analyzed using a GLM repeated measures approach. A priori means comparisons tets (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value =0.197
    Comments A priori threshold for statistical significance was 0.05.
    Method Repeated Measures--General Linear Model
    Comments
    6. Post-Hoc Outcome
    Title AUDIT-C or Drinkers Index (Analysis II)
    Description The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    For this study, at-risk drinking was defined as: AUDIT total >=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 > 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 100 90
    Mean (Standard Error) [units on a scale]
    5.42
    (0.24)
    4.63
    (0.25)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value =0.023
    Comments A priori threshold for statistical significance was 0.05.
    Method Repeated Measures--General Linear Model
    Comments
    7. Post-Hoc Outcome
    Title Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis II)
    Description The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    For this study, at-risk drinking was defined as: AUDIT total >=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 > 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 100 89
    Mean (Standard Error) [units on a scale]
    70.45
    (1.55)
    79.34
    (1.65)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments A priori threshold for statistical significance was 0.05.
    Method Repeated Measures--General Linear Model
    Comments
    8. Post-Hoc Outcome
    Title Readiness to Change Scale (Analysis II)
    Description A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    For this study, at-risk drinking was defined as: AUDIT total >=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 > 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 98 89
    Mean (Standard Error) [units on a scale]
    2.29
    (0.13)
    2.46
    (0.14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value =0.348
    Comments A priori threshold for statistical significance was 0.05.
    Method Repeated Measures--General Linear Model
    Comments
    9. Post-Hoc Outcome
    Title Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis III--complete Cases)
    Description The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    Complete case analysis
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 244 227
    Mean (Standard Error) [units on a scale]
    5.87
    (0.25)
    5.48
    (0.26)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.091
    Comments A priori threshold for statistical significance was 0.05.
    Method Repeated Measures GLM
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value .345
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: .203
    Estimation Comments
    10. Post-Hoc Outcome
    Title AUDIT-C or Drinkers Index (Analysis III Complete Cases)
    Description The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    Complete case analysis
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 244 227
    Mean (Standard Error) [units on a scale]
    4.4
    (.14)
    4.05
    (.15)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value .278
    Comments A priori alpha set at 0.05
    Method Repeated Measures GLM
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value .393
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: .362
    Estimation Comments
    11. Post-Hoc Outcome
    Title Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis III Complete Cases)
    Description The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    Complete case analysis
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 244 227
    Mean (Standard Error) [units on a scale]
    78.66
    (1.0)
    81.82
    (1.04)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.029
    Comments A priori alpha set at 0.05.
    Method Repeated Measures GLM
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 3.163
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.44
    Estimation Comments
    12. Post-Hoc Outcome
    Title Readiness to Change Scale (Analysis III Complete Cases)
    Description A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    Complete case analysis
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 238 221
    Mean (Standard Error) [units on a scale]
    2.21
    (0.08)
    2.20
    (0.09)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.897
    Comments A priori alpha set at 0.05.
    Method Repeated Measures GLM
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.015
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    13. Post-Hoc Outcome
    Title Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis IV--Multiple Imputation and Intention to Treat Analysis)
    Description The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791)
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 403 388
    Mean (Standard Error) [units on a scale]
    4.47
    (0.16)
    4.15
    (0.13)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.15
    Comments
    Method Linear mixed effects
    Comments
    14. Post-Hoc Outcome
    Title AUDIT-C or Drinkers Index (Analysis IV--Intent to Treat Analyses)
    Description The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791)
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 403 388
    Mean (Standard Error) [units on a scale]
    5.95
    (0.21)
    5.62
    (0.23)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.20
    Comments A priori alpha set at 0.05.
    Method Linear mixed effects
    Comments
    15. Post-Hoc Outcome
    Title Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis IV--Intent to Treat Analyses)
    Description The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791)
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 403 388
    Mean (Standard Error) [units on a scale]
    78.42
    (0.85)
    81.30
    (1.05)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.38
    Comments A priori alpha set at 0.05.
    Method Linear mixed effects
    Comments
    16. Post-Hoc Outcome
    Title Readiness to Change Scale (Analysis IV--Multiple Imputation and Intention to Treat Analysis)
    Description A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 403 388
    Mean (Standard Error) [units on a scale]
    2.22
    (0.07)
    2.16
    (0.07)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.
    Type of Statistical Test Other
    Comments A priori alpha set at 0.05
    Statistical Test of Hypothesis p-Value 0.48
    Comments
    Method Linear mixed effects
    Comments
    17. Post-Hoc Outcome
    Title Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis V--Multiple Imputation and Intention to Treat Analysis)
    Description The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 166 161
    Mean (Standard Error) [units on a scale]
    5.38
    (0.25)
    4.85
    (0.20)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.
    Type of Statistical Test Other
    Comments A priori alpha set at 0.05.
    Statistical Test of Hypothesis p-Value 0.09
    Comments
    Method Linear mixed effects
    Comments
    18. Post-Hoc Outcome
    Title AUDIT-C or Drinkers Index (Analysis V--Intent to Treat Analyses)
    Description The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 166 161
    Mean (Standard Error) [units on a scale]
    8.09
    (0.39)
    7.64
    (0.38)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments A priori alpha set at 0.05
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.08
    Comments
    Method Linear mixed effects
    Comments
    19. Post-Hoc Outcome
    Title Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis V--Intent to Treat Analyses)
    Description The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 166 161
    Mean (Standard Error) [units on a scale]
    72.18
    (1.38)
    77.84
    (1.55)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments A priori alpha set at 0.05
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.11
    Comments
    Method Linear mixed effects
    Comments
    20. Post-Hoc Outcome
    Title Readiness to Change Scale (Analysis V--Multiple Imputation and Intention to Treat Analysis)
    Description A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.
    Time Frame Baseline, Follow-up (Up to 7 months)

    Outcome Measure Data

    Analysis Population Description
    Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    Measure Participants 166 161
    Mean (Standard Error) [units on a scale]
    2.33
    (0.10)
    2.35
    (0.12)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Usual Care, SBIRT
    Comments A priori alpha set at 0.05
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.84
    Comments
    Method Linear mixed effects
    Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Usual Care SBIRT
    Arm/Group Description Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time. Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
    All Cause Mortality
    Usual Care SBIRT
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Usual Care SBIRT
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/244 (0%) 0/228 (0%)
    Other (Not Including Serious) Adverse Events
    Usual Care SBIRT
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/244 (0%) 0/228 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Mark B. Reed/Professor and Interim Associate Dean
    Organization San Diego State University Research Foundation
    Phone 619-594-6664
    Email mreed@sdsu.edu
    Responsible Party:
    Mark Reed, PhD, Director, San Diego State University
    ClinicalTrials.gov Identifier:
    NCT02228967
    Other Study ID Numbers:
    • W81XWH-14-2-0014
    • 12019006
    First Posted:
    Aug 29, 2014
    Last Update Posted:
    Sep 9, 2020
    Last Verified:
    Aug 1, 2020