Binge Alcohol Consumption, Suicidal Ideation
Conditions
Keywords
suicidal ideation, binge drinking, emerging adults, feasibility, emergency department, digital health
Brief summary
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
Detailed description
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.
Interventions
BEHAVIORALEA-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/or follow-up and referral services they would otherwise receive and can continue any other behavioral health care.
BEHAVIORALSuicide 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.
Sponsors
University of Massachusetts, Worcester
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
* (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
Exclusion criteria
* (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability as defined by positive ratings on the WAI-TECH-SF | 12 weeks | 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 |
| Feasibility of research protocols, defined as follow-up retention | 12 weeks | Feasibility will be supported by retention of research participants in at least 80% at each of the four assessments |
| Feasibility of research protocols, defined as adherence to the ecological momentary assessment/daily diary protocol | 28 days | Feasibility will be supported by at least 75% of total daily diary surveys across 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety, as defined by number of adverse events in each arm | 12 weeks | Number of adverse events in each arm over 12 weeks |
| Safety, as defined by serious adverse events in each arm | 12 weeks | Safety as defined by serious adverse events in each arm over 12 weeks |
| Safety as defined by worsening of drinking and suicidal ideation severity | 12 weeks | 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 |
| Initial efficacy in binge drinking days, defined as days of binge drinking on the Time Line Follow-Back | 12 weeks | Decreases in days of binge drinking in the past 90 days, as reported on the Time Line Follow Back from Baseline to 12 weeks |
| Early efficacy in suicidal ideation severity, as defined by Beck Suicide Scale scores | 12 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLourah M Kelly, PhD
UMass Chan Medical School, Psychiatry and Behavioral Sciences
Outcome results
None listed