Preliminary Trial of an Avatar Guided Digital Intervention for Emerging Adults

Официальное название

Randomized Controlled Feasibility Trial of an Avatar Guided Intervention for Young Adults Seen in the Emergency Department With Alcohol Use Problems and Suicidal Thoughts

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое EA-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 refe
• Поведенческое Suicide 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.

Первичные конечные точки

• Acceptability as defined by positive ratings on the WAI-TECH-SF [Срок оценки: 12 weeks]
• Feasibility of research protocols, defined as follow-up retention [Срок оценки: 12 weeks]
• Feasibility of research protocols, defined as adherence to the ecological momentary assessment/daily diary protocol [Срок оценки: 28 days]

Вторичные конечные точки (5)

• Safety, as defined by number of adverse events in each arm [Срок оценки: 12 weeks]
• Safety, as defined by serious adverse events in each arm [Срок оценки: 12 weeks]
• Safety as defined by worsening of drinking and suicidal ideation severity [Срок оценки: 12 weeks]
• Initial efficacy in binge drinking days, defined as days of binge drinking on the Time Line Follow-Back [Срок оценки: 12 weeks]
• Early efficacy in suicidal ideation severity, as defined by Beck Suicide Scale scores [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• (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

Критерии исключения

• (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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• UMass Memorial Health - Marlborough Hospital — Marlborough
• UMass Memorial Health - University Campus — Worcester

Идентификаторы

NCT: NCT07418047 · 002997 · R00AA029154

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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