Promoting Healthy Relationships Among At-Risk Adolescents: A Feasibility Trial in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- Participant Acceptability Ratings for Healthcare Provider Discussions on Relationships in ED-Heart Intervention Arm
研究概览
简要总结
This is a single-site, randomized, controlled trial. Investigators will evaluate feasibility of the Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) intervention among adolescents age 14-19 years receiving care in the Children's Mercy emergency department.
详细描述
This study is a mixed methods feasibility evaluation that will use a randomized controlled trial to assess feasibility of Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) (intervention arm: ED-HEART + teen resource list; control arm: enhanced standard care [standard care + teen resource list]). Adolescents age 14-19 years will be recruited and enrolled during an emergency department visit. Investigators will evaluate feasibility using the eight Bowen model feasibility constructs: acceptability, demand, implementation, practicality, adaptation, integration, expansion, and limited-efficacy testing. Investigators will also examine theory of planned behavior constructs (attitudes, beliefs, perceived behavioral control, intention) to facilitate exploratory analysis of factors that may contribute to differential outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •emergency department (ED) patient 14-19 years of age.
排除标准
- •Developmental delay, severe illness, or cognitive impairment precluding informed consent/assent or completion of study activities, as determined by ED team or study team.
- •Current ED evaluation for acute sexual assault/abuse.
- •Current mental or behavioral health symptoms precluding completion of study activities, as determined by ED team or study team.
- •Caregiver declines to step out to allow assent/consent in private or adolescent declines for caregiver to step out to allow assent/consent or participation in private.
- •Adolescent is non-English speaking.
- •Parent is non-English or non-Spanish speaking.
结局指标
主要结局
Participant Acceptability Ratings for Healthcare Provider Discussions on Relationships in ED-Heart Intervention Arm
时间窗: 12 weeks
1 survey item (investigator-developed) on acceptability of healthcare providers discussing healthy/unhealthy relationships, rated using 5-point Likert scale (strongly disagree/1 to strongly agree/5)
Participant Acceptability Ratings for ED-based Relationship Intervention in ED-Heart Intervention Arm
时间窗: 12 weeks
1 survey item (investigator-developed) on acceptability of emergency department based healthy/unhealthy relationships intervention, rated using 5-point Likert scale (strongly disagree/1 to strongly agree/5)
次要结局
- ARA Victimization(12 weeks)
- Recognition of Abusive Behaviors(12 weeks)
研究者
Kimberly Randell
Physician, MD
Children's Mercy Hospital Kansas City