Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-02-22 @ 2:56 AM
Study NCT ID:
NCT02228967
Status:
COMPLETED
Last Update Posted:
2020-09-09
First Post:
2014-08-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Alcohol Screening, Brief Intervention, and Referral to Treatment in a Military Treatment Facility
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008403', 'term': 'Mass Screening'}, {'id': 'D003419', 'term': 'Crisis Intervention'}, {'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mreed@sdsu.edu', 'phone': '619-594-6664', 'title': 'Mark B. Reed/Professor and Interim Associate Dean', 'organization': 'San Diego State University Research Foundation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', '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.', 'otherNumAtRisk': 244, 'otherNumAffected': 0, 'seriousNumAtRisk': 244, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.', 'otherNumAtRisk': 228, 'otherNumAffected': 0, 'seriousNumAtRisk': 228, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Alcohol Use Disorders Identification Test (AUDIT) Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.91', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.274', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A priori threshold for statistical significance was 0.05', 'groupDescription': '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.', 'statisticalMethod': 'Repeated Measures--General Linear Model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Excludes low-risk participants defined as AUDIT \\<=7 at baseline. A total of 17 participants were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'AUDIT-C or Drinkers Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.41', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '4.05', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.083', 'groupIds': ['OG000', 'OG001'], 'groupDescription': '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.', 'statisticalMethod': 'Repeated Measures--General Linear Model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Excludes low-risk participants defined as AUDIT \\<=7 at baseline. A total of 17 participants were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Controlled Drinking Self-Efficacy Scale (CDSES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.42', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '81.67', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.028', 'groupIds': ['OG000', 'OG001'], 'groupDescription': '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.', 'statisticalMethod': 'Repeated Measures--General Linear Model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Excludes low-risk participants defined as AUDIT \\<=7 at baseline. A total of 17 participants were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Readiness to Change Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.23', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '2.19', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.708', 'groupIds': ['OG000', 'OG001'], 'groupDescription': '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.', 'statisticalMethod': 'Repeated Measures--General Linear Model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'POST_HOC', 'title': 'Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '7.31', 'spread': '0.34', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.197', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A priori threshold for statistical significance was 0.05.', 'groupDescription': '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.', 'statisticalMethod': 'Repeated Measures--General Linear Model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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)'}, {'type': 'POST_HOC', 'title': 'AUDIT-C or Drinkers Index (Analysis II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.42', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '4.63', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.023', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A priori threshold for statistical significance was 0.05.', 'groupDescription': '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.', 'statisticalMethod': 'Repeated Measures--General Linear Model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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)'}, {'type': 'POST_HOC', 'title': 'Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.45', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '79.34', 'spread': '1.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A priori threshold for statistical significance was 0.05.', 'groupDescription': '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.', 'statisticalMethod': 'Repeated Measures--General Linear Model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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)'}, {'type': 'POST_HOC', 'title': 'Readiness to Change Scale (Analysis II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.29', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '2.46', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.348', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A priori threshold for statistical significance was 0.05.', 'groupDescription': '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.', 'statisticalMethod': 'Repeated Measures--General Linear Model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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)'}, {'type': 'POST_HOC', 'title': 'Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis III--complete Cases)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.87', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '5.48', 'spread': '0.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.091', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.345', 'pValueComment': 'A priori threshold for statistical significance was 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.203', 'groupDescription': '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.', 'statisticalMethod': 'Repeated Measures GLM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis'}, {'type': 'POST_HOC', 'title': 'AUDIT-C or Drinkers Index (Analysis III Complete Cases)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '.14', 'groupId': 'OG000'}, {'value': '4.05', 'spread': '.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.278', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.393', 'pValueComment': 'A priori alpha set at 0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.362', 'groupDescription': '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.', 'statisticalMethod': 'Repeated Measures GLM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis'}, {'type': 'POST_HOC', 'title': 'Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis III Complete Cases)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.66', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '81.82', 'spread': '1.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.163', 'pValueComment': 'A priori alpha set at 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.44', 'groupDescription': '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.', 'statisticalMethod': 'Repeated Measures GLM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis'}, {'type': 'POST_HOC', 'title': 'Readiness to Change Scale (Analysis III Complete Cases)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.21', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '2.20', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.897', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.015', 'pValueComment': 'A priori alpha set at 0.05.', 'groupDescription': '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.', 'statisticalMethod': 'Repeated Measures GLM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis'}, {'type': 'POST_HOC', 'title': 'Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis IV--Multiple Imputation and Intention to Treat Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.47', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '4.15', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.', 'statisticalMethod': 'Linear mixed effects', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791)'}, {'type': 'POST_HOC', 'title': 'AUDIT-C or Drinkers Index (Analysis IV--Intent to Treat Analyses)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.95', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '5.62', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.20', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A priori alpha set at 0.05.', 'groupDescription': 'Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.', 'statisticalMethod': 'Linear mixed effects', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791)'}, {'type': 'POST_HOC', 'title': 'Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis IV--Intent to Treat Analyses)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.42', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '81.30', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A priori alpha set at 0.05.', 'groupDescription': 'Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.', 'statisticalMethod': 'Linear mixed effects', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791)'}, {'type': 'POST_HOC', 'title': 'Readiness to Change Scale (Analysis IV--Multiple Imputation and Intention to Treat Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.22', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '2.16', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.', 'statisticalMethod': 'Linear mixed effects', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A priori alpha set at 0.05'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis V--Multiple Imputation and Intention to Treat Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.38', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '4.85', 'spread': '0.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.', 'statisticalMethod': 'Linear mixed effects', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A priori alpha set at 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.'}, {'type': 'POST_HOC', 'title': 'AUDIT-C or Drinkers Index (Analysis V--Intent to Treat Analyses)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.09', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '7.64', 'spread': '0.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A priori alpha set at 0.05', 'statisticalMethod': 'Linear mixed effects', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.'}, {'type': 'POST_HOC', 'title': 'Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis V--Intent to Treat Analyses)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.18', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '77.84', 'spread': '1.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A priori alpha set at 0.05', 'statisticalMethod': 'Linear mixed effects', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.'}, {'type': 'POST_HOC', 'title': 'Readiness to Change Scale (Analysis V--Multiple Imputation and Intention to Treat Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', '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.'}, {'id': 'OG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.33', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '2.35', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.84', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A priori alpha set at 0.05', 'statisticalMethod': 'Linear mixed effects', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', '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.'}, {'id': 'FG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '403'}, {'groupId': 'FG001', 'numSubjects': '388'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '244'}, {'groupId': 'FG001', 'numSubjects': '228'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '160'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '146'}, {'groupId': 'FG001', 'numSubjects': '142'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '18'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'BG000'}, {'value': '388', 'groupId': 'BG001'}, {'value': '791', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', '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.'}, {'id': 'BG001', 'title': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.\n\nSBIRT: 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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'spread': '6', 'groupId': 'BG000'}, {'value': '26.3', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '26.3', 'spread': '5.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '300', 'groupId': 'BG000'}, {'value': '280', 'groupId': 'BG001'}, {'value': '580', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}]}, {'title': 'African-American', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '215', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '429', 'groupId': 'BG002'}]}]}, {'title': 'Asian/Hawaiian/Pacific Islander', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'American Indian/Alaskan Native', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '403', 'groupId': 'BG000'}, {'value': '388', 'groupId': 'BG001'}, {'value': '791', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Self-Reported PTSD Diagnosis', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '387', 'groupId': 'BG000'}, {'value': '367', 'groupId': 'BG001'}, {'value': '754', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital Status', 'classes': [{'categories': [{'title': 'Single', 'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}, {'title': 'Married/Co-habitating', 'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '334', 'groupId': 'BG002'}]}, {'title': 'Divorced/Separated/Widowed', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education Level', 'classes': [{'categories': [{'title': 'High School Graduate/GED', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '318', 'groupId': 'BG002'}]}, {'title': 'Some College', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}, {'title': '2-Year College Degree (AA)', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': '4-Year Degree (BA/BS)', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Graduate Degree', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Service Branch', 'classes': [{'categories': [{'title': 'Navy', 'measurements': [{'value': '336', 'groupId': 'BG000'}, {'value': '320', 'groupId': 'BG001'}, {'value': '656', 'groupId': 'BG002'}]}, {'title': 'Marine Corps', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'Army/Air Force/Coast Guard', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Combat Deployments (past 5-years)', 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '425', 'groupId': 'BG002'}]}, {'title': '1-2', 'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}]}, {'title': '3 or more', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol Use Disorders Identification Test (AUDIT) Score', 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '8.0', 'spread': '5.1', 'groupId': 'BG001'}, {'value': '7.7', 'spread': '4.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The AUDIT is the Alcohol Use Disorders identification test (Babor et al., 2001). The AUDIT is a screening assessment designed to help identify risky drinking. The AUDIT ranges from a score of 0 to 40 with higher values indicating riskier drinking.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Readiness to Change Drinking', 'classes': [{'categories': [{'measurements': [{'value': '1.95', 'spread': '1.17', 'groupId': 'BG000'}, {'value': '1.96', 'spread': '1.15', 'groupId': 'BG001'}, {'value': '1.96', 'spread': '1.16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Controlled Drinking Self-Efficacy Scale (CDSES)', 'classes': [{'categories': [{'measurements': [{'value': '76.9', 'spread': '15.3', 'groupId': 'BG000'}, {'value': '78', 'spread': '15', 'groupId': 'BG001'}, {'value': '77.9', 'spread': '15.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The 20-item Controlled Drinking Self-Efficacy Scale (CDSES; Sitharthan et al., 2003), 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 higher scores indicating more confidence to engage in controlled drinking. Items for the CDSES will be combined and averaged to form a scaled score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 791}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-21', 'studyFirstSubmitDate': '2014-08-26', 'resultsFirstSubmitDate': '2018-11-07', 'studyFirstSubmitQcDate': '2014-08-27', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-29', 'studyFirstPostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol Use Disorders Identification Test (AUDIT) Total', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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."}], 'secondaryOutcomes': [{'measure': 'AUDIT-C or Drinkers Index', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.'}, {'measure': 'Controlled Drinking Self-Efficacy Scale (CDSES)', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.'}, {'measure': 'Readiness to Change Scale', 'timeFrame': 'Baseline, Follow-up (Up to 7 months)', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alcohol Use', 'SBIRT', 'Military', 'Health Behavior', 'Emergency Room', 'Health Promotion', 'Formative Research', 'Randomized Trial'], 'conditions': ['Alcohol Dependency']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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:\n\n1. 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.\n2. 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.\n\n In addition, exploratory analyses will examine the following:\n3. 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.', 'detailedDescription': '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.\n\nObjective 1: Feasibility and Acceptability\n\n* Determine how the SBIRT intervention can be integrated into standard military emergency department (ED) operations by conducting record review and observation of the ED.\n* 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.\n* Develop an implementation/operations protocol for delivering SBIRT in the ED.\n\nObjective 2: Adaptation\n\n* 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.\n* 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.\n\nObjective 3: Pilot Trial\n\n* 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:\n* Apply a randomization method in the ED to assign active duty participants to experimental condition.\n* Implement the SBIRT intervention in the ED for those assigned to the intervention arm.\n* Implement a process for obtaining follow-up data with this mobile population.\n* Assess presumed mediators (e.g., readiness/motivation to change and self-efficacy) and moderators (e.g., PTSD status, gender) of alcohol misuse change.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 or Older\n* Active Duty\n* Off Duty\n* Telephone Number for Follow-up\n* Healthy Enough to Participate\n* Positive Screen for Risky Drinking\n\nExclusion Criteria:\n\n* Under 18\n* Non-Military\n* On Duty\n* Low Level Drinking'}, 'identificationModule': {'nctId': 'NCT02228967', 'briefTitle': 'Alcohol Screening, Brief Intervention, and Referral to Treatment in a Military Treatment Facility', 'organization': {'class': 'OTHER', 'fullName': 'San Diego State University'}, 'officialTitle': 'Feasibility and Pilot Testing of SBI to Reduce Alcohol Misuse Among Active Duty Members in a Military ER Setting', 'orgStudyIdInfo': {'id': 'W81XWH-14-2-0014'}, 'secondaryIdInfos': [{'id': '12019006', 'type': 'OTHER_GRANT', 'domain': 'Congressionally Directed Medical Research Programs'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', '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.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SBIRT', 'description': 'Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:\n\n1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.\n2. 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.\n3. 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.', 'interventionNames': ['Behavioral: SBIRT']}], 'interventions': [{'name': 'SBIRT', 'type': 'BEHAVIORAL', 'otherNames': ['Screening', 'Brief Intervention', 'Brief Treatment', 'Referral to Treatment', 'Motivational Interviewing'], 'description': '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.', 'armGroupLabels': ['SBIRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92134', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Naval Medical Center San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Mark Reed, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SDSURF - Center for Alcohol & Drug Studies & Services'}, {'name': 'Gerard DeMers, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'United States Naval Medical Center, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Diego State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Naval Medical Center, San Diego', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Mark Reed, PhD', 'investigatorAffiliation': 'San Diego State University'}}}}