Relationship Abuse Prevention Intervention Implemented With Sexual and Gender Diverse Youth and Their Caregivers - Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Acceptability
研究概览
简要总结
This is a pilot clinical trial to test an intervention called FLARE, which is an adolescent relationship abuse prevention program for sexual and gender diverse youth and their trusted adults. FLARE comprises in-person, virtual, and asynchronous programming developed by and for caregivers and adolescents.
详细描述
In this pilot trial, the investigators will be testing FLARE, a dating violence prevention program for sexual and gender diverse youth and their trusted adults. The study will be comparing FLARE to a wait-list control. This trial will focus on assessing acceptability, feasibility, and fidelity, as well as exploratory changes in behavioral outcomes. FLARE includes 1 in-person full day session, 2 virtual large group sessions, and several asynchronous components (website, workbook, card game). FLARE runs over a 4 week period.
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
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •SGDY eligibility includes:
- •ages 14 to 18
- •identifies as sexually or gender diverse (e.g., gay, lesbian, bisexual, queer, transgender, or nonbinary)
- •uses English
- •willing to travel to Pittsburgh for 1 in-person event; and
- •can identify a caregiver who can also participate.
- •Caregivers eligibility includes:
- •age 18 or older;
- •a caregiver of an SGDY ages 14 to 18;
- •uses English;
- •willing to travel to Pittsburgh for 1 in-person event; and
- •has a child participating in this study. Caregivers can include parents or any other person whom the adolescent identifies as a trusted adult in their life. We will only enroll 1 caregiver for each SGDY; because this is a dyadic study each adolescent needs a matched participating caregiver and vice versa.
排除标准
- •Does not meet eligibility criteria
- •Incarcerated during the study
- •Unable to provide verbal or REDCap consent or assent
研究组 & 干预措施
Wait list control
Wait list control participants will be offered the opportunity to participate in the intervention after the investigators have completed the pilot trial
干预措施: Resource Guide (Behavioral)
FLARE intervention
FLARE participants will receive the intervention
干预措施: FLARE (Behavioral)
结局指标
主要结局
Acceptability
时间窗: T2 (1 month post baseline)
Acceptability of Intervention Measure: Mean value of 4 items. Each question uses a five-point Likert scale for responses, coded with a value from 1 (Completely disagree) to 5 (Completely agree) and averaged to produce the mean value. The higher the computed mean value, the greater acceptability of the intervention.
Trial Feasibility
时间窗: T1 (baseline); T2 (1 month post baseline); T3 (3 months post baseline, 2 months post T2)
Trial Consent Rate: % of individuals who assented/consented to participate out of individuals who screened eligible Trial Baseline Participation Rate: % of individuals who completed the baseline survey out of individuals who assented/consented to participate Trial Intervention Demand: % of intervention arm participants who complete the intervention Trial Retention Rate: % of participants who complete each followup survey
次要结局
- Attitudes about abusive behaviors(T1 (baseline); T3 (3 months post baseline, 2 months post T2))
- Attitudes towards diverse identities(T1 (baseline); T3 (3 months post baseline, 2 months post T2))
- Self-efficacy(T1 (baseline); T3 (3 months post baseline, 2 months post T2))
- Parenting confidence(T1 (baseline); T3 (3 months post baseline, 2 months post T2))
- Caregiver self-efficacy(T1 (baseline); T3 (3 months post baseline, 2 months post T2))
- Motivation(T1 (baseline); T3 (3 months post baseline, 2 months post T2))
- Resource utilization(T1 (baseline); T3 (3 months post baseline, 2 months post T2))
- Dating related parenting monitoring(T1 (baseline); T3 (3 months post baseline, 2 months post T2))
- Parenting monitoring(T1 (baseline); T3 (3 months post baseline, 2 months post T2))
- LGBTQ Caregiver(T1 (baseline); T3 (3 months post baseline, 2 months post T2))
- parent-adolescent communication(T1 (baseline); T3 (3 months post baseline, 2 months post T2))
- Adolescent relationship abuse(T1 (baseline); T3 (3 months post baseline, 2 months post T2))
研究者
Maya Ragavan
Associate Professor of Pediatrics
University of Pittsburgh