Preliminary Trial of an Avatar Guided Digital Intervention for Emerging Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-29
SponsorUniversity of Massachusetts, Worcester
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(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)
Disqualifiers
(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
Trial design
Design model
Parallel
Treatments tested in this trial
EA-Avatar
BehavioralThe 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.
Suicide safety planning app
BehavioralA 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Avatar guided digital health intervention for emerging adults (EA-Avatar)Experimental treatment 1 intervention
Group B: Suicide safety plan appActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
12 weeks2
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 weeks3
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 daysSecondary outcomes
1
Safety, as defined by number of adverse events in each arm
Number of adverse events in each arm over 12 weeks
Time frame
12 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Massachusetts, Worcester
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov