An Affirmative Coping Skills Intervention to Improve Mental and Sexual Health of Sexual and Gender Minority Youth (AFFIRM): A Stepped Wedge Waitlist Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 7
- 主要终点
- Acceptability - participant satisfaction with group sessions
研究概览
简要总结
AFFIRM is an 8-session manualized group coping skills intervention focused on reducing sexual risk behaviours and psychosocial distress among SGMY. AFFIRM is delivered by two facilitators (primarily social workers and peers) through a combination of education and rehearsal (i.e., simulation of real-life experiences) in a manner that affirms participants' sexual and gender minority identities and experiences. AFFIRM is being tested in a five-year trial using a stepped wedge waitlist crossover design, where all participants receive the intervention in clusters.
详细描述
Session 1 focus
Introduction to cognitive behavioral therapy (CBT), exploring lesbian, gay, bisexual, transgender, and queer (LGBTQ)+ identities, and understanding minority stress.
Session 1 activities
Introductions
Discussing the theory and purpose of CBT approaches
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Participants are not blinded as they know which arm they are allocated too. Care providers and outcome assessors are blinded as the investigator runs the allocation sequence and outcomes are administered via survey weblink
入排标准
- 年龄范围
- 14 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 14 to 29 years at time of screening
- •Identifies as a sexual and/or gender minority
- •Reads, writes, and speaks fluent English
- •Is interested in participating in the 8-session AFFIRM intervention
排除标准
- •Assessed to be in crisis (i.e., high risk of suicidality)
- •Warrenting a more intensive intervention
研究组 & 干预措施
AFFIRM
AFFIRM is an 8-session psychoeducational weekly group intervention
干预措施: AFFIRM (Behavioral)
Waitlisted control
Waitlisted control
结局指标
主要结局
Acceptability - participant satisfaction with group sessions
时间窗: week 56
Participants will complete a satisfaction questionnaire.
Feasibility - participant attendance at group sessions
时间窗: week 56
Proportions of participants that enroll, commence, and complete the intervention.
次要结局
- Intervention fidelity - how closely facilitators adhere to intervention model(Study period sessions 1-8 (weeks 1-8))
研究者
Shelley Craig
Professor
University of Toronto