Avatar-Led Digital Therapeutic to Aid Smoking Cessation Among Sexual and Gender Minority Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- 7-day point prevalence abstinence (PPA) from all nicotine and tobacco use
研究概览
简要总结
This trial assesses the acceptability and preliminary efficacy of Empowered, Queer, Quitting, and Living (EQQUAL) smoking-cessation intervention for sexual and gender minority young adult smokers. The prevalence of tobacco use among sexual and gender minority (SGM) young adults is more than twice as high as non-SGM young adults, suggesting that existing SGM-related disparities in tobacco use will persist well into the foreseeable future unless sustained efforts are undertaken to address them. EQQUAL is an online smoking cessation intervention designed specifically for SGM young adult smokers, and may help them quit smoking.
详细描述
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive self-guided, online quit smoking program, called EQQUAL Program A.
ARM II: Participants receive self-guided online quit smoking program, EQQUAL Program B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DEMOGRAPHIC CRITERIA:
- •Participants must self-identify being between 18 and 30 years of age
- •Participants must self-identify as a sexual and/or gender minority (i.e., a sexual orientation other than straight and/or gender that doesn't match sex assigned at birth)
- •Participants must currently reside in the United States, with a United States (US) mailing address, and anticipate remaining in the US for the duration of the study (3 months)
- •SMOKING CRITERIA:
- •Participants must self-report smoking at least 1 cigarette per day in the 30 days prior to screening
- •TREATMENT ACCESSIBILITY:
- •Participants must self-report having at least weekly Internet access for the next three months
- •Participants must self-report being willing and able to stream audio and video online for this study
- •Participants must self-report current use of a personal email account
- •Participants must self-report current use of text messaging
- •OTHER CRITERIA:
- •Participants must self-report that they are interested in participating in the study for themselves (versus [vs] someone else)
- •Participants must self-report that they have not participated in one of our prior smoking cessation studies
- •Participants must self-report that they are comfortable reading, writing, and speaking English
- •Participants must self-report that they understand and agree to the conditions of compensation
- •Participants must self-report that they are not currently incarcerated
- •Participants must be willing to use the assigned intervention program, complete the study assessments, and consent to participate in this study
- •Participants must be willing to upload a photo of themselves (face visible)
排除标准
- •Participants must not be currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (but initiating these treatments during the study is allowed)
- •Participants must not be a member of the same household as another research participant
- •Having a Google voice number as their sole phone number
结局指标
主要结局
7-day point prevalence abstinence (PPA) from all nicotine and tobacco use
时间窗: At 3-month follow-up
Self-report of no nicotine and tobacco use over the past 7 days, biochemically confirmed via saliva cotinine. Will test for statistical differences between arms using a logistic regression, with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders).
Overall satisfaction
时间窗: At 3-month follow-up
Will be assessed with a 5-point Likert-type item on the 3-month survey. Responses will be recorded into a binary variable representing responses of "mostly satisfied" or "very satisfied" versus all other responses (i.e., "not at all," "a little," and "somewhat"). Will test for statistical differences between arms using a logistic regression, with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders).
Reduction in cigarettes smoked per day
时间窗: Baseline through 3-month follow-up
Change in cigarette smoked per day will be assessed as the difference between average number of cigarettes smoked per day over the past 7 days at baseline and at 3-month follow-up. Will test for statistical differences between arms using a negative binomial regression with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders).
Usability of the Empowered, Queer, Quitting, and Living (EQQUAL) program
时间窗: At 3-month follow-up
Measured by the System Usability Scale. Will be presented descriptively as an average usability score.
Acceptability of the EQQUAL avatar
时间窗: At 3-month follow-up
Will be assessed using the Agent Persona Instrument, an adapted version of the Robotics Social Attribute Scale, and 4 open-ended, study specific questions. Will be presented descriptively as frequencies and percentages.
Average change in Contemplation Ladder scores
时间窗: Baseline through 3-month follow-up
Contemplation Ladder scores will be used to assess readiness to quit using cigarettes. Will test for statistical differences between arms using linear regression, with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders).
Number of EQQUAL sessions completed
时间窗: Up to 3 months
Will be presented descriptively as frequencies and percentages.
次要结局
- Changes in the acceptance of smoking triggers(Baseline through 3-month follow-up)
- Changes in psychological flexibility(Baseline through 3-month follow-up)
- Differences in 3-month smoking outcomes between those with high versus low baseline readiness to quit(Baseline through 3-month follow-up)
- Differences in 3-month smoking outcomes between those who identify as gender minority versus those who don't(Baseline through 3-month follow-up)
- Changes in valued living(Baseline through 3-month follow-up)