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| ID | Type | Description | Link |
|---|---|---|---|
| R00AA029154 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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This study is an open pilot usability trial to test the 1) usability of a newly developed mobile health intervention to help manage suicidal ideation and alcohol use problems and 2) feasibility of research protocols with emerging adults (18-29 year-olds) who present to the emergency department.
This study is an open pilot usability trial with emerging adults presenting to the emergency department with binge drinking and suicidal thoughts. The main study aims are to test the usability of a newly developed avatar-guided mobile health intervention and feasibility of 28 days of daily assessments and four follow-ups at 4-, 8-, and 12-weeks after discharge.
Ten emerging adults aged 18-29 years old will be recruited from the emergency department who have suicidal ideation and alcohol use problems. Exclusion criteria are conditions that would preclude research participation (e.g., cognitive disabilities, in police custody; at imminent risk of harming oneself in the emergency department).
All ten participants will be given access to a newly designed avatar-guided digital intervention and text message intervention (EA-Avatar) for 12 weeks in addition to usual emergency department care. 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 usability of the avatar intervention and qualitative interviews of the intervention and research protocols.
Based on participant qualitative interviews, a scale of usability of the digital intervention, feedback surveys, recruitment and retention in the study, participant completion of daily diary and ecological assessment surveys, and analysis of mobile intervention usage data, the intervention will be revised, before testing in a larger randomized controlled feasibility trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EA-Avatar | Experimental | The avatar-guided digital intervention includes monitoring of alcohol use and common triggers 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 provide reminders to access the avatar platform to learn or practice skills and provide encouragement. EA-Avatar is given in addition to emergency department care as usual. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EA-Avatar | Behavioral | The avatar-guided digital intervention includes monitoring of alcohol use and common triggers 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 provide reminders to access the avatar platform to learn or practice skills and provide encouragement. |
| Measure | Description | Time Frame |
|---|---|---|
| Usability of the EA-Avatar digital intervention, defined by ratings on the System Usability Scale | If any System Usability Items are less than 3.5 out of 5, those aspects of the digital intervention will be revised in the beta version. | 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 EMA and daily diary surveys across 28 days | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of EA-Avatar as rated on participant feedback surveys | Feedback on the alpha version of EA-Avatar measured via a feedback survey with items rated on a 4-point likert scale from strongly disagree to strongly agree, which assesses opinions about avatar appearance and customizations, the helpfulness of skills, and helpfulness of features of the platform | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lourah M. Kelly | UMass Worcester (UMass Chan Medical School) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Memorial Health - Marlborough Hospital | Marlborough | Massachusetts | 01752 | United States | ||
| UMass Memorial, University Campus |
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.
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.
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This is a single group open pilot trial, in order to test the usability of the EA-Avatar digital intervention and feasibility of the research protocols of the EA-Avatar intervention.
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| Worcester |
| Massachusetts |
| 05145 |
| United States |
| ID | Term |
|---|---|
| D063425 | Binge Drinking |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D000428 | Alcohol Drinking |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
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