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. The main questions this study aims to answer are: * Do participants use the digital program and find it helpful? * Is it possible for participants to complete daily surveys for twenty-eight days and follow-up surveys over twelve weeks? * Are there early signs that the program may help lower alcohol use and suicidal thoughts? Researchers 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. Participants will: * Receive standard care from the emergency department * Be randomly put into one of two groups (EA-Avatar or a free suicide prevention app) * Depending on their group, use a new avatar-guided digital support program with text message reminders OR use a free suicide safety planning app * Complete surveys at the start of the study and again at four, eight, and twelve weeks * 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. Sixty emerging adults aged 18-29 who have received care in the emergency department for alcohol use problems and/or 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). Participants 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. Primary 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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/or follow-up and referral services they would otherwise receive and can continue any other behavioral health care.
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.
UMass Memorial Health - Marlborough Hospital
Marlborough, Massachusetts, United States
RECRUITINGUMass Memorial Health - University Campus
Worcester, Massachusetts, United States
RECRUITINGAcceptability 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
Time frame: 12 weeks
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
Time frame: 12 weeks
Feasibility of research protocols, defined as adherence to the ecological momentary assessment/daily diary protocol
Feasibility will be supported by at least 75% of total daily diary surveys across 28 days
Time frame: 28 days
Safety, as defined by number of adverse events in each arm
Number of adverse events in each arm over 12 weeks
Time frame: 12 weeks
Safety, as defined by serious adverse events in each arm
Safety as defined by serious adverse events in each arm over 12 weeks
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Time frame: 12 weeks
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.
Time frame: 12 weeks
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