Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:52 PM
Study NCT ID:
NCT05873556
Status:
COMPLETED
Last Update Posted:
2025-03-25
First Post:
2023-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Testing Brief Personalized Feedback Integrating Lab-based Alcohol Cue Information
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'afairlie@uw.edu', 'phone': '2062215896', 'title': 'Dr. Anne Fairlie', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This is a small pilot trial designed to collect feasibility and acceptability information. The study (enrollment through 3-month) went from May 2023 to March 2024; the COVID-19 pandemic may have impacted alcohol use and contexts of alcohol use. All findings are based on self-report of alcohol use. Analyses reported here restrict the sample to 93 to account for a programming error (subsequently fixed) where control participants were initially being incorrectly emailed a link to the feedback.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected between initial screening and final follow-up for each participant, a period of approximately 4 months.', 'description': 'We used clinicaltrials.gov definitions for adverse events and serious adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Assessment-only Control', 'description': 'Participants randomized to the control group will not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)', 'description': "Participants randomized to the Lab-based Cue Reactivity PFI condition will receive a link to the personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.\n\nLab-based Cue Reactivity Personalized Feedback Intervention (PFI): This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.", 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Daily Drinking Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Assessment-only Control', 'description': 'Participants randomized to the control group will not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback.'}, {'id': 'OG001', 'title': 'Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)', 'description': "Participants randomized to the Lab-based Cue Reactivity PFI condition will receive a link to the personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.\n\nLab-based Cue Reactivity Personalized Feedback Intervention (PFI): This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.24', 'spread': '5.16', 'groupId': 'OG000'}, {'value': '12.27', 'spread': '7.95', 'groupId': 'OG001'}]}]}, {'title': '2-Week Follow-Up', 'categories': [{'measurements': [{'value': '8.79', 'spread': '7.25', 'groupId': 'OG000'}, {'value': '9.73', 'spread': '6.95', 'groupId': 'OG001'}]}]}, {'title': '3-Month Follow-Up', 'categories': [{'measurements': [{'value': '6.97', 'spread': '5.46', 'groupId': 'OG000'}, {'value': '9.14', 'spread': '7.70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.83', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Count/Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.27', 'groupDescription': 'Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.', 'statisticalMethod': 'Generalized linear mixed model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.', 'nonInferiorityComment': 'Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.'}, {'pValue': '0.61', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Count/Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.38', 'groupDescription': 'Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.', 'statisticalMethod': 'Generalized linear mixed model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.', 'nonInferiorityComment': 'Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 week follow-up, and 3 month follow-up', 'description': 'Number of standard drinks consumed on each day of a typical week during the \\[past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up\\]. Participants responded on a scale from 0 (0 drinks) to 25 (25 or more drinks). Totals for each day are summed to calculate the typical number of drinks consumed per week.', 'unitOfMeasure': 'Drinks per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Heavy Episodic Drinking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Assessment-only Control', 'description': 'Participants randomized to the control group will not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback.'}, {'id': 'OG001', 'title': 'Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)', 'description': "Participants randomized to the Lab-based Cue Reactivity PFI condition will receive a link to the personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.\n\nLab-based Cue Reactivity Personalized Feedback Intervention (PFI): This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.45', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '2.47', 'spread': '2.17', 'groupId': 'OG001'}]}]}, {'title': '2-Week Follow-Up', 'categories': [{'measurements': [{'value': '1.86', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '2.18', 'spread': '1.75', 'groupId': 'OG001'}]}]}, {'title': '3-Month Follow-Up', 'categories': [{'measurements': [{'value': '1.53', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '1.86', 'spread': '1.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.45', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Count/Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.72', 'groupDescription': 'Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.', 'statisticalMethod': 'Generalized linear mixed model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.', 'nonInferiorityComment': 'Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.'}, {'pValue': '0.46', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Count/Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.79', 'groupDescription': 'Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.', 'statisticalMethod': 'Generalized linear mixed model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.', 'nonInferiorityComment': 'Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 week follow-up, and 3 month follow-up', 'description': 'Participants were asked, "During the past two weeks, how many times did you have \\[4/5 for females/males\\] or more drinks at one sitting?". Participants responded on a scale from 0 (0 times) to 10 (10 or more times) and possible range was 0-10.', 'unitOfMeasure': 'Heavy Drinking Occasions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Penn Alcohol Craving Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Assessment-only Control', 'description': 'Participants randomized to the control group will not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback.'}, {'id': 'OG001', 'title': 'Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)', 'description': "Participants randomized to the Lab-based Cue Reactivity PFI condition will receive a link to the personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.\n\nLab-based Cue Reactivity Personalized Feedback Intervention (PFI): This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.93', 'spread': '3.96', 'groupId': 'OG000'}, {'value': '8.04', 'spread': '4.11', 'groupId': 'OG001'}]}]}, {'title': '2-Week Follow-Up', 'categories': [{'measurements': [{'value': '7.31', 'spread': '4.81', 'groupId': 'OG000'}, {'value': '8.04', 'spread': '5.44', 'groupId': 'OG001'}]}]}, {'title': '3-Month Follow-Up', 'categories': [{'measurements': [{'value': '5.74', 'spread': '4.23', 'groupId': 'OG000'}, {'value': '7.24', 'spread': '5.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Count/Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.17', 'groupDescription': 'Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.', 'statisticalMethod': 'Generalized linear mixed model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.', 'nonInferiorityComment': 'Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.'}, {'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Count/Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.48', 'groupDescription': 'Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.', 'statisticalMethod': 'Generalized linear mixed model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.', 'nonInferiorityComment': 'Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 week follow-up, and 3 month follow-up', 'description': 'Self-reported subjective alcohol craving during the past week. Response options were scored from "0" to "6" with text varying across items. A sum score of the five items was calculated and the possible range was from 0-30. Higher scores reflect more craving.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Brief Young Adult Alcohol Consequences Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Assessment-only Control', 'description': 'Participants randomized to the control group will not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback.'}, {'id': 'OG001', 'title': 'Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)', 'description': "Participants randomized to the Lab-based Cue Reactivity PFI condition will receive a link to the personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.\n\nLab-based Cue Reactivity Personalized Feedback Intervention (PFI): This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.74', 'spread': '5.18', 'groupId': 'OG000'}, {'value': '9.92', 'spread': '5.02', 'groupId': 'OG001'}]}]}, {'title': '2-Week Follow-Up', 'categories': [{'measurements': [{'value': '4.88', 'spread': '4.80', 'groupId': 'OG000'}, {'value': '5.78', 'spread': '5.11', 'groupId': 'OG001'}]}]}, {'title': '3-Month Follow-Up', 'categories': [{'measurements': [{'value': '6.11', 'spread': '5.26', 'groupId': 'OG000'}, {'value': '7.06', 'spread': '5.37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.66', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Count/Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.54', 'groupDescription': 'Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.', 'statisticalMethod': 'Generalized linear mixed model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.', 'nonInferiorityComment': 'Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.'}, {'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Count/Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.38', 'groupDescription': 'Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.', 'statisticalMethod': 'Generalized linear mixed model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.', 'nonInferiorityComment': 'Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 week follow-up, and 3 month follow-up', 'description': 'Participants responded "no" (0) or "yes" (1) to whether they experienced each of 24 consequences during the \\[past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up\\]. A sum of the number of negative alcohol-related consequences was calculated and the possible range was 0-24. Higher values represent a worse outcome (i.e., more consequences).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Assessment-only Control', 'description': 'Participants randomized to the control group will not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback.'}, {'id': 'FG001', 'title': 'Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)', 'description': "Participants randomized to the Lab-based Cue Reactivity PFI condition will receive a link to the personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.\n\nLab-based Cue Reactivity Personalized Feedback Intervention (PFI): This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from Washington state (e.g., via Instagram). Individuals were invited to complete an online eligibility survey for participation in a randomized clinical trial to test the effect of an online personalized feedback intervention. Recruitment (i.e., posting ads on social media) went from April 2023 to December 2023. Participant enrollment (i.e., completion of lab session) went from May 2023 to December 2023.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Assessment-only Control', 'description': 'Participants randomized to the control group will not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback.'}, {'id': 'BG001', 'title': 'Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)', 'description': "Participants randomized to the Lab-based Cue Reactivity PFI condition will receive a link to the personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.\n\nLab-based Cue Reactivity Personalized Feedback Intervention (PFI): This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.93', 'spread': '1.66', 'groupId': 'BG000'}, {'value': '21.04', 'spread': '1.87', 'groupId': 'BG001'}, {'value': '21.44', 'spread': '1.82', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Student Status', 'classes': [{'categories': [{'title': '4-year student', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Not a 4-year student', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-02-15', 'size': 111560, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-15T12:05', 'hasProtocol': True}, {'date': '2025-02-15', 'size': 101141, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-15T12:06', 'hasProtocol': False}, {'date': '2023-01-19', 'size': 206851, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-02-15T12:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to one of two conditions: (1) Personalized feedback based on reports from baseline and lab-session and (2) assessment-only control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2023-05-15', 'resultsFirstSubmitDate': '2025-02-15', 'studyFirstSubmitQcDate': '2023-05-15', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-21', 'studyFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily Drinking Questionnaire', 'timeFrame': 'Baseline, 2 week follow-up, and 3 month follow-up', 'description': 'Number of standard drinks consumed on each day of a typical week during the \\[past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up\\]. Participants responded on a scale from 0 (0 drinks) to 25 (25 or more drinks). Totals for each day are summed to calculate the typical number of drinks consumed per week.'}, {'measure': 'Heavy Episodic Drinking', 'timeFrame': 'Baseline, 2 week follow-up, and 3 month follow-up', 'description': 'Participants were asked, "During the past two weeks, how many times did you have \\[4/5 for females/males\\] or more drinks at one sitting?". Participants responded on a scale from 0 (0 times) to 10 (10 or more times) and possible range was 0-10.'}, {'measure': 'Penn Alcohol Craving Scale', 'timeFrame': 'Baseline, 2 week follow-up, and 3 month follow-up', 'description': 'Self-reported subjective alcohol craving during the past week. Response options were scored from "0" to "6" with text varying across items. A sum score of the five items was calculated and the possible range was from 0-30. Higher scores reflect more craving.'}, {'measure': 'Brief Young Adult Alcohol Consequences Questionnaire', 'timeFrame': 'Baseline, 2 week follow-up, and 3 month follow-up', 'description': 'Participants responded "no" (0) or "yes" (1) to whether they experienced each of 24 consequences during the \\[past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up\\]. A sum of the number of negative alcohol-related consequences was calculated and the possible range was 0-24. Higher values represent a worse outcome (i.e., more consequences).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Consumption']}, 'descriptionModule': {'briefSummary': "This study aims to develop a brief intervention that uses information from a lab-based cue reactivity protocol to create personalized feedback targeting high-risk alcohol use among young adults who drink alcohol. The intervention provides feedback on individuals' drinking desire, mood, willingness to drink, and alcohol demand by comparing scores before and after viewing and smelling an alcoholic beverage in the lab session. Other psycho-educational alcohol-related content is also provided in the intervention including strategies for decreasing exposure to cues that increase drinking desires and how to cope with increased desire to drink. This brief intervention is used in a randomized controlled trial (RCT) comparing young adults who receive the brief, online intervention to those who did not receive the brief, online intervention. Participants in both groups complete baseline, lab-based cue reactivity protocol, 2-week follow-up and 3-month follow-up.", 'detailedDescription': "The purpose of this study is to develop and test a brief intervention that provides personalized feedback to young adults using participants' responses from a baseline survey and from a lab-based cue reactivity protocol. The aim of the intervention is to increase young adults' awareness of how alcohol cues may affect their desire to drink, mood, willingness to drink, and alcohol demand both in relation to lab-based exposure to an alcohol beverage of their choice and also more broadly in everyday life. The intervention also aims to equip young adults with strategies for reducing exposure to factors that increase their desire to drink, how to cope with an increased desire to drink, and how to reduce potential harms from drinking.\n\nThis brief personalized feedback intervention is used in a randomized controlled trial comparing young adults who receive the intervention with those who complete the assessments and lab protocol but do not receive any personalized feedback. Online assessments include an eligibility survey, baseline assessment, and follow-up assessments occurring 2-weeks and 3-months post-intervention. Everyone has one in-person session to complete the lab-based cue reactivity protocol after the baseline assessment has been completed online. The intervention will be examined for its feasibility, acceptability, and its effects in reducing alcohol-related outcomes at the follow-up assessments."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between ages 18-24\n* Lives in Washington state\n* Reports drinking at least two days per week in the last six months\n* Reports at least one heavy drinking episode (4+/5+ drinks for women/men) in the past month\n* Open to changing drinking behavior\n* Must be willing to come to our Seattle study office for session visit\n* Provide an email address and phone number for study communication\n\nExclusion Criteria:\n\n* Actively seeking treatment for alcohol use\n* Currently participating in another study in our research center regarding young adult drinking behavior'}, 'identificationModule': {'nctId': 'NCT05873556', 'acronym': 'Project ACE', 'briefTitle': 'Testing Brief Personalized Feedback Integrating Lab-based Alcohol Cue Information', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Development and Preliminary Examination of Two Brief Personalized Feedback Interventions Focused on Lab-based and EMA Alcohol Cues to Reduce Hazardous Young Adult Alcohol Use', 'orgStudyIdInfo': {'id': 'STUDY00016989'}, 'secondaryIdInfos': [{'id': 'R34AA027302', 'link': 'https://reporter.nih.gov/quickSearch/R34AA027302', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)', 'description': "Participants randomized to the Lab-based Cue Reactivity PFI condition view the online personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.", 'interventionNames': ['Behavioral: Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)']}, {'type': 'NO_INTERVENTION', 'label': 'Assessment-only control', 'description': 'Participants randomized to the control group do not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback.'}], 'interventions': [{'name': 'Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)', 'type': 'BEHAVIORAL', 'description': "This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.", 'armGroupLabels': ['Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Jason Ramirez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'Anne Fairlie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Data dictionaries and limited datasets can be made available starting in May 2024.', 'ipdSharing': 'YES', 'description': 'The investigators plan to share limited, de-identified datasets for the purposes of data analysis and dissemination.', 'accessCriteria': 'Individual requests to access data with intended purpose should be made to Drs. Fairlie and Ramirez and will be reviewed by the investigative team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Acting Assistant Professor: School of Medicine', 'investigatorFullName': 'Jason Ramirez', 'investigatorAffiliation': 'University of Washington'}}}}