Alcohol Dependency
Conditions
Keywords
Alcohol Use, SBIRT, Military, Health Behavior, Emergency Room, Health Promotion, Formative Research, Randomized Trial
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: 3. 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.
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.
Interventions
BEHAVIORALSBIRT
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.
Sponsors
United States Naval Medical Center, San Diego
San Diego State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 403 |
| SBIRT Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:
1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.
2. 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.
3. 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. | 388 |
| Total | 791 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 146 | 142 |
| Overall Study | Withdrawal by Subject | 13 | 18 |
Baseline characteristics
| Characteristic | Usual Care | SBIRT | Total |
|---|---|---|---|
| Age, Continuous | 26.4 Years STANDARD_DEVIATION 6 | 26.3 Years STANDARD_DEVIATION 5.7 | 26.3 Years STANDARD_DEVIATION 5.9 |
| Alcohol Use Disorders Identification Test (AUDIT) Score | 7.7 units on a scale STANDARD_DEVIATION 4.2 | 8.0 units on a scale STANDARD_DEVIATION 5.1 | 7.7 units on a scale STANDARD_DEVIATION 4.6 |
| Controlled Drinking Self-Efficacy Scale (CDSES) | 76.9 units on a scale STANDARD_DEVIATION 15.3 | 78 units on a scale STANDARD_DEVIATION 15 | 77.9 units on a scale STANDARD_DEVIATION 15.2 |
| Education Level 2-Year College Degree (AA) | 52 Participants | 43 Participants | 95 Participants |
| Education Level 4-Year Degree (BA/BS) | 46 Participants | 50 Participants | 96 Participants |
| Education Level Graduate Degree | 13 Participants | 18 Participants | 31 Participants |
| Education Level High School Graduate/GED | 169 Participants | 149 Participants | 318 Participants |
| Education Level Some College | 123 Participants | 128 Participants | 251 Participants |
| Marital Status Divorced/Separated/Widowed | 39 Participants | 30 Participants | 69 Participants |
| Marital Status Married/Co-habitating | 161 Participants | 173 Participants | 334 Participants |
| Marital Status Single | 203 Participants | 185 Participants | 388 Participants |
| Number of Combat Deployments (past 5-years) 1-2 | 173 Participants | 148 Participants | 321 Participants |
| Number of Combat Deployments (past 5-years) 3 or more | 19 Participants | 25 Participants | 44 Participants |
| Number of Combat Deployments (past 5-years) Missing | 0 Participants | 1 Participants | 1 Participants |
| Number of Combat Deployments (past 5-years) None | 211 Participants | 214 Participants | 425 Participants |
| Race/Ethnicity, Customized African-American | 74 Participants | 71 Participants | 145 Participants |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 4 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian/Hawaiian/Pacific Islander | 10 Participants | 15 Participants | 25 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 85 Participants | 64 Participants | 149 Participants |
| Race/Ethnicity, Customized Other | 15 Participants | 22 Participants | 37 Participants |
| Race/Ethnicity, Customized White | 215 Participants | 214 Participants | 429 Participants |
| Readiness to Change Drinking | 1.95 units on a scale STANDARD_DEVIATION 1.17 | 1.96 units on a scale STANDARD_DEVIATION 1.15 | 1.96 units on a scale STANDARD_DEVIATION 1.16 |
| Region of Enrollment United States | 403 participants | 388 participants | 791 participants |
| Self-Reported PTSD Diagnosis No | 387 Participants | 367 Participants | 754 Participants |
| Self-Reported PTSD Diagnosis Yes | 16 Participants | 21 Participants | 37 Participants |
| Service Branch Army/Air Force/Coast Guard | 9 Participants | 14 Participants | 23 Participants |
| Service Branch Marine Corps | 57 Participants | 54 Participants | 111 Participants |
| Service Branch Missing | 1 Participants | 0 Participants | 1 Participants |
| Service Branch Navy | 336 Participants | 320 Participants | 656 Participants |
| Sex: Female, Male Female | 103 Participants | 108 Participants | 211 Participants |
| Sex: Female, Male Male | 300 Participants | 280 Participants | 580 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 244 | 0 / 228 |
| serious Total, serious adverse events | 0 / 244 | 0 / 228 |
Outcome results
Primary
Alcohol Use Disorders Identification Test (AUDIT) Total
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)
Population: Excludes low-risk participants defined as AUDIT \<=7 at baseline. A total of 17 participants were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Alcohol Use Disorders Identification Test (AUDIT) Total | 5.91 units on a scale | Standard Error 0.26 |
| SBIRT | Alcohol Use Disorders Identification Test (AUDIT) Total | 5.5 units on a scale | Standard Error 0.27 |
Comparison: 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.p-value: =0.274Repeated Measures--General Linear Model
Secondary
AUDIT-C or Drinkers Index
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)
Population: Excludes low-risk participants defined as AUDIT \<=7 at baseline. A total of 17 participants were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | AUDIT-C or Drinkers Index | 4.41 units on a scale | Standard Error 0.14 |
| SBIRT | AUDIT-C or Drinkers Index | 4.05 units on a scale | Standard Error 0.15 |
Comparison: 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.p-value: =0.083Repeated Measures--General Linear Model
Secondary
Controlled Drinking Self-Efficacy Scale (CDSES)
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)
Population: Excludes low-risk participants defined as AUDIT \<=7 at baseline. A total of 17 participants were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Controlled Drinking Self-Efficacy Scale (CDSES) | 78.42 units on a scale | Standard Error 1.01 |
| SBIRT | Controlled Drinking Self-Efficacy Scale (CDSES) | 81.67 units on a scale | Standard Error 1.07 |
Comparison: 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.p-value: =0.028Repeated Measures--General Linear Model
Secondary
Readiness to Change Scale
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)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Readiness to Change Scale | 2.23 units on a scale | Standard Error 0.08 |
| SBIRT | Readiness to Change Scale | 2.19 units on a scale | Standard Error 0.09 |
Comparison: 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.p-value: =0.708Repeated Measures--General Linear Model
Post Hoc
Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis II)
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)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis II) | 8.2 units on a scale | Standard Error 0.47 |
| SBIRT | Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis II) | 7.31 units on a scale | Standard Error 0.34 |
Comparison: 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.p-value: =0.197Repeated Measures--General Linear Model
Post Hoc
Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis III--complete Cases)
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)
Population: Complete case analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis III--complete Cases) | 5.87 units on a scale | Standard Error 0.25 |
| SBIRT | Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis III--complete Cases) | 5.48 units on a scale | Standard Error 0.26 |
Comparison: 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.p-value: 0.091Repeated Measures GLM
Post Hoc
Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis IV--Multiple Imputation and Intention to Treat Analysis)
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)
Population: Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis IV--Multiple Imputation and Intention to Treat Analysis) | 4.47 units on a scale | Standard Error 0.16 |
| SBIRT | Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis IV--Multiple Imputation and Intention to Treat Analysis) | 4.15 units on a scale | Standard Error 0.13 |
Comparison: Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.p-value: 0.15Linear mixed effects
Post Hoc
Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis V--Multiple Imputation and Intention to Treat Analysis)
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)
Population: Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis V--Multiple Imputation and Intention to Treat Analysis) | 5.38 units on a scale | Standard Error 0.25 |
| SBIRT | Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis V--Multiple Imputation and Intention to Treat Analysis) | 4.85 units on a scale | Standard Error 0.2 |
Comparison: Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.p-value: 0.09Linear mixed effects
Post Hoc
AUDIT-C or Drinkers Index (Analysis II)
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)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | AUDIT-C or Drinkers Index (Analysis II) | 5.42 units on a scale | Standard Error 0.24 |
| SBIRT | AUDIT-C or Drinkers Index (Analysis II) | 4.63 units on a scale | Standard Error 0.25 |
Comparison: 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.p-value: =0.023Repeated Measures--General Linear Model
Post Hoc
AUDIT-C or Drinkers Index (Analysis III Complete Cases)
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)
Population: Complete case analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | AUDIT-C or Drinkers Index (Analysis III Complete Cases) | 4.4 units on a scale | Standard Error 0.14 |
| SBIRT | AUDIT-C or Drinkers Index (Analysis III Complete Cases) | 4.05 units on a scale | Standard Error 0.15 |
Comparison: 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.p-value: 0.278Repeated Measures GLM
Post Hoc
AUDIT-C or Drinkers Index (Analysis IV--Intent to Treat Analyses)
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)
Population: Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | AUDIT-C or Drinkers Index (Analysis IV--Intent to Treat Analyses) | 5.95 units on a scale | Standard Error 0.21 |
| SBIRT | AUDIT-C or Drinkers Index (Analysis IV--Intent to Treat Analyses) | 5.62 units on a scale | Standard Error 0.23 |
Comparison: Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.p-value: 0.2Linear mixed effects
Post Hoc
AUDIT-C or Drinkers Index (Analysis V--Intent to Treat Analyses)
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)
Population: Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | AUDIT-C or Drinkers Index (Analysis V--Intent to Treat Analyses) | 8.09 units on a scale | Standard Error 0.39 |
| SBIRT | AUDIT-C or Drinkers Index (Analysis V--Intent to Treat Analyses) | 7.64 units on a scale | Standard Error 0.38 |
Comparison: A priori alpha set at 0.05p-value: 0.08Linear mixed effects
Post Hoc
Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis II)
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)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis II) | 70.45 units on a scale | Standard Error 1.55 |
| SBIRT | Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis II) | 79.34 units on a scale | Standard Error 1.65 |
Comparison: 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.p-value: <0.001Repeated Measures--General Linear Model
Post Hoc
Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis III Complete Cases)
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)
Population: Complete case analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis III Complete Cases) | 78.66 units on a scale | Standard Error 1 |
| SBIRT | Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis III Complete Cases) | 81.82 units on a scale | Standard Error 1.04 |
Comparison: 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.p-value: 0.029Repeated Measures GLM
Post Hoc
Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis IV--Intent to Treat Analyses)
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)
Population: Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis IV--Intent to Treat Analyses) | 78.42 units on a scale | Standard Error 0.85 |
| SBIRT | Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis IV--Intent to Treat Analyses) | 81.30 units on a scale | Standard Error 1.05 |
Comparison: Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.p-value: 0.38Linear mixed effects
Post Hoc
Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis V--Intent to Treat Analyses)
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)
Population: Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis V--Intent to Treat Analyses) | 72.18 units on a scale | Standard Error 1.38 |
| SBIRT | Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis V--Intent to Treat Analyses) | 77.84 units on a scale | Standard Error 1.55 |
Comparison: A priori alpha set at 0.05p-value: 0.11Linear mixed effects
Post Hoc
Readiness to Change Scale (Analysis II)
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)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Readiness to Change Scale (Analysis II) | 2.29 units on a scale | Standard Error 0.13 |
| SBIRT | Readiness to Change Scale (Analysis II) | 2.46 units on a scale | Standard Error 0.14 |
Comparison: 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.p-value: =0.348Repeated Measures--General Linear Model
Post Hoc
Readiness to Change Scale (Analysis III Complete Cases)
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)
Population: Complete case analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Readiness to Change Scale (Analysis III Complete Cases) | 2.21 units on a scale | Standard Error 0.08 |
| SBIRT | Readiness to Change Scale (Analysis III Complete Cases) | 2.20 units on a scale | Standard Error 0.09 |
Comparison: 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.p-value: 0.897Repeated Measures GLM
Post Hoc
Readiness to Change Scale (Analysis IV--Multiple Imputation and Intention to Treat Analysis)
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Readiness to Change Scale (Analysis IV--Multiple Imputation and Intention to Treat Analysis) | 2.22 units on a scale | Standard Error 0.07 |
| SBIRT | Readiness to Change Scale (Analysis IV--Multiple Imputation and Intention to Treat Analysis) | 2.16 units on a scale | Standard Error 0.07 |
Comparison: Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.p-value: 0.48Linear mixed effects
Post Hoc
Readiness to Change Scale (Analysis V--Multiple Imputation and Intention to Treat Analysis)
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)
Population: Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Readiness to Change Scale (Analysis V--Multiple Imputation and Intention to Treat Analysis) | 2.33 units on a scale | Standard Error 0.1 |
| SBIRT | Readiness to Change Scale (Analysis V--Multiple Imputation and Intention to Treat Analysis) | 2.35 units on a scale | Standard Error 0.12 |
Comparison: A priori alpha set at 0.05p-value: 0.84Linear mixed effects