Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R00AA029154 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
Not provided
Not provided
Not provided
Not provided
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avatar guided digital health intervention for emerging adults (EA-Avatar) | Experimental | 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. |
|
| Suicide safety plan app | Active Comparator | Participants are given information to download a freely available suicide safety planning app. 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EA-Avatar | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 | 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 | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, as defined by number of adverse events in each arm | Number of adverse events in each arm over 12 weeks | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lourah M Kelly, PhD | UMass Chan Medical School, Psychiatry and Behavioral Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Memorial Health - Marlborough Hospital | Recruiting | Marlborough | Massachusetts | 01752 | United States |
De-identified data will be shared with per reasonable request to the PI, after the final report and data is published in a peer-reviewed scientific journal. Data will also be submitted to the National Data Archive.
6 months after the last participant completes the study (completes their 12 week follow-up), data will be analyzed and submitted for publication in a peer-reviewed scientific journal.
After publication of main and secondary outcomes in a peer-reviewed journal, de-identified data will be available upon reasonable request to the PI. Data will also be available in the National Data Archive in either October or April following study completion, whichever comes first.
Not provided
Not provided
| ID | Term |
|---|---|
| D063425 | Binge Drinking |
| D059020 | Suicidal Ideation |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D000428 | Alcohol Drinking |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Suicide safety planning app | Behavioral | 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. |
|
| 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 | 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 | 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. | 12 weeks |
| UMass Memorial Health - University Campus | Recruiting | Worcester | Massachusetts | 01545 | United States |
|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |