[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07418047":3,"trial-entities:NCT07418047":132,"trial-summary:NCT07418047":136},{"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":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":47,"secondary_outcomes":59,"sex":75,"minimum_age":76,"maximum_age":77,"healthy_volunteers":78,"eligibility_criteria":79,"std_ages":96,"locations":98,"central_contacts":125,"overall_officials":126,"references":130,"see_also_links":131},"NCT07418047","002997","Preliminary Trial of an Avatar Guided Digital Intervention for Emerging Adults","Randomized Controlled Feasibility Trial of an Avatar Guided Intervention for Young Adults Seen in the Emergency Department With Alcohol Use Problems and Suicidal Thoughts","RECRUITING","2027-08-31","2026-07","2026-08-03","2026-06-10","University of Massachusetts, Worcester","OTHER",true,"The goal of this clinical trial is to learn whether a novel digital avatar (virtual coach) support program can help emerging adults ages 18-29 who present to the emergency department with suicidal thoughts and alcohol misuse (EA-Avatar). The study also aims to learn whether people find the program easy to use and whether daily surveys and the study design are able to be completed by the majority of emerging adult participants.\n\nThe main questions this study aims to answer are:\n\n* Do participants use the digital program and find it helpful?\n* Is it possible for participants to complete daily surveys for twenty-eight days and follow-up surveys over twelve weeks?\n* Are there early signs that the program may help lower alcohol use and suicidal thoughts?\n\nResearchers will compare participants who receive the new digital avatar program plus supportive text messages to participants who receive a freely available suicide safety planning app to see if there are differences in use, engagement, and early signs of benefit.\n\nParticipants will:\n\n* Receive standard care from the emergency department\n* Be randomly put into one of two groups (EA-Avatar or a free suicide prevention app)\n* Depending on their group, use a new avatar-guided digital support program with text message reminders OR use a free suicide safety planning app\n* Complete surveys at the start of the study and again at four, eight, and twelve weeks\n* Complete short daily surveys for twenty-eight days","This study is a randomized controlled feasibility study with emerging adults presenting to the emergency department with alcohol misuse and suicidal ideation, to test the acceptability, feasibility, safety, and initial efficacy of a newly developed digital intervention, as well as the feasibility of research protocols.\n\nSixty emerging adults aged 18-29 who have received care in the emergency department for alcohol use problems and\u002For suicidal thoughts will be recruited and asked to complete assessments at baseline, four weeks, eight weeks, and twelve weeks, as well as twenty-eight consecutive days of daily diary surveys. Half of participants will be given access to a newly designed avatar-guided digital intervention and text message intervention for emerging adults(EA-Avatar), while half will receive a freely available suicide safety planning app. Exclusion criteria are conditions that would preclude research participation (e.g., cognitive disabilities, in police custody; under guardianship; at imminent risk of harming oneself in the emergency department).\n\nParticipants will complete measures of alcohol use, suicidal ideation, and alcohol-related cognitions and experiences, as well as service utilization. They will also complete a scale of acceptability of the avatar intervention and qualitative interviews of the intervention and research protocols.\n\nPrimary aims include participant acceptability of the intervention as rated by satisfaction surveys and feasibility of study procedures and assessments as defined by completion of follow-up assessment and daily surveys for 28 days. Secondary aims include early signals of potential effects on alcohol use severity, binge drinking days, and suicidal ideation severity, as well as safety as defined by adverse and serious adverse events and worsening of alcohol use problems or suicidal ideation severity from baseline to 12 weeks.",[19,20],"Binge Alcohol Consumption","Suicidal Ideation",[22,23,24,25,26,27],"suicidal ideation","binge drinking","emerging adults","feasibility","emergency department","digital health","INTERVENTIONAL","TREATMENT",[31],"NA",{"count":33,"type":34},60,"ESTIMATED",[36,42],{"type":37,"name":38,"description":39,"armGroupLabels":40},"BEHAVIORAL","EA-Avatar","The avatar-guided digital intervention includes monitoring of alcohol use and triggers of suicidal thoughts, skills to manage alcohol use and suicidal thoughts, resources on how to access outpatient care and crisis hotlines for suicidal thoughts, and achievements for milestones. In addition, text messages with inspirational quotes and reminders to access the avatar platform are used to support engagement and foster hope. They are also given any emergency department care and\u002For follow-up and referral services they would otherwise receive and can continue any other behavioral health care.",[41],"Avatar guided digital health intervention for emerging adults (EA-Avatar)",{"type":37,"name":43,"description":44,"armGroupLabels":45},"Suicide safety planning app","A publicly available suicide safety planning app which includes guidance on creating a Stanley-Brown Safety Plan, including warning signs, things users can do on their own when feeling suicidal, people who can distract them, people who can support them, professionals or organizations who can support them, and reasons for living.",[46],"Suicide safety plan app",[48,52,55],{"measure":49,"description":50,"timeFrame":51},"Acceptability as defined by positive ratings on the WAI-TECH-SF","Positive ratings on the Working Alliance Inventory Technology Version, Short Form (WAI-TECH-SF) as measured by an average of 4 out of 7 or higher on the mean score. Minimum = 1, Maximum = 7, higher scores mean better acceptability","12 weeks",{"measure":53,"description":54,"timeFrame":51},"Feasibility of research protocols, defined as follow-up retention","Feasibility will be supported by retention of research participants in at least 80% at each of the four assessments",{"measure":56,"description":57,"timeFrame":58},"Feasibility of research protocols, defined as adherence to the ecological momentary assessment\u002Fdaily diary protocol","Feasibility will be supported by at least 75% of total daily diary surveys across 28 days","28 days",[60,63,66,69,72],{"measure":61,"description":62,"timeFrame":51},"Safety, as defined by number of adverse events in each arm","Number of adverse events in each arm over 12 weeks",{"measure":64,"description":65,"timeFrame":51},"Safety, as defined by serious adverse events in each arm","Safety as defined by serious adverse events in each arm over 12 weeks",{"measure":67,"description":68,"timeFrame":51},"Safety as defined by worsening of drinking and suicidal ideation severity","Safety as defined by worsening of alcohol use problems or suicidal ideation severity from baseline to 12 weeks, in increases of the sample standard deviation in either problem",{"measure":70,"description":71,"timeFrame":51},"Initial efficacy in binge drinking days, defined as days of binge drinking on the Time Line Follow-Back","Decreases in days of binge drinking in the past 90 days, as reported on the Time Line Follow Back from Baseline to 12 weeks",{"measure":73,"description":74,"timeFrame":51},"Early efficacy in suicidal ideation severity, as defined by Beck Suicide Scale scores","Decreases in severity of suicidal ideation in the past month, as reported on the Beck Suicide Scale items 1-19, from Baseline to 12 weeks, Minimum score = 0, maximum score = 57.","ALL","18 Years","29 Years",false,{"inclusion":80,"exclusion":89,"raw_text":95},[81,82,83,84,85,86,87,88],"(1) emergency department admission for alcohol- or suicide-related reason since turning 18, OR treated for incidental suicide risk in the emergency department","(2) aged 18-29","(3) speak, read, and understand English","(4) binge drinking in the past month OR alcohol use problems (Alcohol Use Disorders Identification Test score \\> 5)","(5) active suicidal ideation in the past month","(6) owning and having access to a personal smartphone","(7) willingness to be randomized to an avatar guided intervention for alcohol use problems and suicidal thoughts OR a freely available suicide safety planning app","(8) for remote MyChart-based recruitment only, have MyChart activated",[90,91,92,93,94],"(1) severe cognitive delay, active psychosis, or heavy intoxication that precludes research participation","(2) imminent safety risk and have been recently unsafe to themselves or others","(3) prisoner or are under arrest","(4) not interested or not willing to be randomized to receive the avatar-guided digital intervention or safety plan app","(5) under the care of a legal guardian","Inclusion Criteria:\n\n* (1) emergency department admission for alcohol- or suicide-related reason since turning 18, OR treated for incidental suicide risk in the emergency department\n* (2) aged 18-29\n* (3) speak, read, and understand English\n* (4) binge drinking in the past month OR alcohol use problems (Alcohol Use Disorders Identification Test score \\> 5)\n* (5) active suicidal ideation in the past month\n* (6) owning and having access to a personal smartphone\n* (7) willingness to be randomized to an avatar guided intervention for alcohol use problems and suicidal thoughts OR a freely available suicide safety planning app\n* (8) for remote MyChart-based recruitment only, have MyChart activated\n\nExclusion Criteria:\n\n* (1) severe cognitive delay, active psychosis, or heavy intoxication that precludes research participation\n* (2) imminent safety risk and have been recently unsafe to themselves or others\n* (3) prisoner or are under arrest\n* (4) not interested or not willing to be randomized to receive the avatar-guided digital intervention or safety plan app\n* (5) under the care of a legal guardian",[97],"ADULT",[99,115],{"facility":100,"status":8,"city":101,"state":102,"zip":103,"country":104,"contacts":105,"geoPoint":112},"UMass Memorial Health - Marlborough Hospital","Marlborough","Massachusetts","01752","United States",[106,111],{"name":107,"role":108,"phone":109,"email":110},"Lourah M Kelly, PhD","CONTACT","508-948-8973","lourah.kelly@umassmed.edu",{"name":107,"role":108},{"lat":113,"lon":114},42.34593,-71.55229,{"facility":116,"status":8,"city":117,"state":102,"zip":118,"country":104,"contacts":119,"geoPoint":122},"UMass Memorial Health - University Campus","Worcester","01545",[120,121],{"name":107,"role":108,"phone":109,"email":110},{"name":107,"role":108},{"lat":123,"lon":124},42.26259,-71.80229,[],[127],{"name":107,"affiliation":128,"role":129},"UMass Chan Medical School, Psychiatry and Behavioral Sciences","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":133,"biomarkers":135},[134,20],"Drinking binge",[],{"nct_id":4,"found":15,"summary":137,"prompt_version":147},{"design":138,"status":139,"heading":140,"summary":141,"follow_up":142,"word_count":143,"commitments":144,"compensation":145,"drugs_mentioned":146},"This is a randomized controlled study with 60 participants. Half will receive the EA-Avatar program, and the other half will use a publicly available suicide safety planning app.","completed","Digital Intervention for Emerging Adults with Alcohol Misuse and Suicidal Thoughts","This study is testing a new digital program called EA-Avatar, which uses a virtual coach to help young adults (ages 18-29) who have experienced suicidal thoughts and alcohol misuse. The program offers tools to manage alcohol use and suicidal thoughts, and provides resources for support. Researchers want to see if people find EA-Avatar helpful and easy to use. They also want to know if participants can complete daily surveys for 28 days and follow-up surveys for 12 weeks. The study is also looking for early signs that the program might help reduce alcohol use and suicidal thoughts. You may be able to join if you are 18-29, speak English, and have been to the emergency department for alcohol or suicide-related reasons, or have active suicidal thoughts and binge drinking.","Participants will be followed for 12 weeks after starting the study.",129,"Participants will complete assessments at the start, and at 4, 8, and 12 weeks. They will also complete daily surveys for 28 consecutive days.","Not stated in the trial record.",[38],"v2"]