[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07726004":3,"trial-entities:NCT07726004":85,"trial-summary:NCT07726004":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":38,"secondary_outcomes":52,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":15,"eligibility_criteria":56,"std_ages":60,"locations":62,"central_contacts":80,"overall_officials":82,"references":83,"see_also_links":84},"NCT07726004","24-2079","Development of an Alcohol, Cannabis, and Sexual Assault Risk Reduction Program for High Risk College Women","Development of an Alcohol, Cannabis, and Sexual Assault Risk Reduction Program for High Risk College Women, Pilot RCT","NOT_YET_RECRUITING","2027-02","2026-07","2026-07-24","2026-08","University of Colorado, Denver","OTHER",true,"The goal of this clinical trial is to assess the feasibility of the Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program with alcohol and cannabis content (EAAA+) in undergraduate college women between ages 18-24 years old who use alcohol and cannabis. The main objectives it aims to answer are:\n\n* To determine the feasibility of a randomized controlled trial comparing EAAA+ to an assessment only control condition.\n* To determine if EAAA+ will result in larger decreases in HED and cannabis use, more accurate perceptions of alcohol and cannabis norms, and greater increases in PBS at follow up.\n* To determine if EAAA+ will result in (1) greater increases in SA risk perception and use of assertive SA resistance strategies and (2) decreased barriers to SA resistance while using alcohol and cannabis, and (3) greater reductions in incapacitated SA.\n\nResearchers will compare participants who received EAAA+ to an assessment only condition to test the objectives stated above.\n\nParticipants will:\n\n* Sign an informed consent form and complete a survey. Once the survey is completed, they will be randomly assigned to complete the sexual assault education program or not.\n* Participants assigned to the sexual assault education program will complete two in-person sessions (about 7 hours each) or four in-person sessions (about 3.5 hours each) and will also complete an online module in between modules 2 and 3 as part of the education program and complete four short surveys.\n* Complete 4 weeks of assessments and complete a follow-up survey at 1, 3, and 6 months after the initial session.",null,[19],"Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program With Alcohol and Cannabis Content",[],"INTERVENTIONAL","BASIC_SCIENCE",[24],"NA",{"count":26,"type":27},200,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program","Participants will be randomized to EAAA+, a combined program for alcohol and cannabis prevention and sexual assault risk reduction.",[31],{"type":30,"name":35,"description":36,"armGroupLabels":37},"Assessment Only Control","Participants will be randomized to an assessment only control.",[35],[39,43,46,49],{"measure":40,"description":41,"timeFrame":42},"Cannabis Use Frequency Measured at Follow-Ups","Cannabis use frequency will be reported using a self-report at 1-month and 3- and 6-month follow ups.","Up to 1-month, 3-months, and 6-months post intervention",{"measure":44,"description":45,"timeFrame":42},"Heavy Episodic Drinking Frequency Measured at Follow-Ups","Heavy episodic drinking (HED) frequency will be reported using a self-report at 1-month and 3- and 6-month follow ups.",{"measure":47,"description":48,"timeFrame":42},"Attempted Sexual Assault Measured at Follow-Ups","Attempted sexual assault will be reported using a self-report at 1-month and 3- and 6-month follow ups.",{"measure":50,"description":51,"timeFrame":42},"Completed Sexual Assault Measured at Follow-Ups","Completed sexual assault will be reported using a self-report at 1-month and 3- and 6-month follow ups.",[],"FEMALE","18 Years","24 Years",{"inclusion":57,"exclusion":58,"raw_text":59},[],[],"Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study determined at pre-screening\n3. Between the ages of 18-24 years old determined at pre-screening\n4. Identifies as a woman determined at pre-screening\n5. Is currently enrolled as an undergraduate in Colorado with a valid student email address determined at pre-screening\n6. Engaged in heavy episodic drinking (i.e., 4+ drinks within a two-hour period) at least once in the past month with an intention to drink in the future determined at pre-screening\n7. Engaged in using cannabis at least once in the past month with an intention to use in the future determined at pre-screening\n8. Is available to attend sessions on specific dates\n9. Has a phone they can complete web-based surveys on determined at pre-screening\n\nExclusion Criteria:\n\n1\\. There are no exclusion criteria aside from not meeting inclusion criteria.",[61],"ADULT",[63],{"facility":64,"city":65,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":77},"University of Colorado Anschutz Medical Campus","Aurora","Colorado","80045","United States",[70,75],{"name":71,"role":72,"phone":73,"email":74},"Ruschelle M Leone, PhD","CONTACT","303-724-7052","ruschelle.leone@cuanschutz.edu",{"name":71,"role":76},"PRINCIPAL_INVESTIGATOR",{"lat":78,"lon":79},39.72943,-104.83192,[81],{"name":71,"role":72,"phone":73,"email":74},[],[],[],{"nct_id":4,"conditions":86,"biomarkers":90},[87,88,89],"Alcohol Consumption","Cannabis misuse","Sexual Assault Risk",[],{"nct_id":4,"found":15,"summary":92,"prompt_version":102},{"design":93,"status":94,"heading":95,"summary":96,"follow_up":97,"word_count":98,"commitments":99,"compensation":100,"drugs_mentioned":101},"This is an interventional study where participants will be randomly assigned to either receive the EAAA+ program or be in an assessment-only control group. It plans to enroll 200 women.","completed","Alcohol, Cannabis, and Sexual Assault Risk Reduction Program for College Women","This study is testing a program called the Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program with alcohol and cannabis content (EAAA+). This program aims to help college women reduce their use of alcohol and cannabis, and lower their risk of sexual assault. Researchers want to see if EAAA+ is a practical program to offer and if it can lead to bigger reductions in heavy drinking and cannabis use, more accurate understanding of alcohol and cannabis norms, and increased protective behavioral strategies compared to an assessment-only group. You may be able to join if you are a woman between 18 and 24 years old, attend college, and use alcohol and cannabis. The study is currently unclear about its recruitment status and plans to enroll 200 participants.","Participants will be followed for up to 6 months after the intervention to measure cannabis use, heavy episodic drinking, and attempted sexual assault.",127,"Participants will be randomized to either the EAAA+ program or an assessment-only control. They will be assessed at up to 1-month, 3-months, and 6-months after the intervention.","Not stated in the trial record.",[31],"v2"]