Engaging Together for Healthy Relationships Version 2.0: Multisite Pilot Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Percentage of participants who complete the 1-month post-intervention survey out of the total who consented
研究概览
简要总结
ETHR V 2.0 pilot trial is a one-arm, multi-site pilot trial to assess the acceptability and feasibility of Engaging Together for Healthy Relationships, a caregiver-adolescent dating violence prevention program delivered within pediatric primary care.
详细描述
ETHR V 2.0 pilot trial is a one-arm (intervention only) pilot trial of Engaging Together for Healthy Relationships, a caregiver-adolescent dating violence prevention program delivered within pediatric primary care. We completed one round of the pilot trial in two clinics in Pittsburgh and now are expanding the trial to include two sites with all providers in each site. ETHR includes clinician training, in-clinic resources, and after visit text messages and resources for families. This is an intervention only trial to assess acceptability, feasibility, and exploratory pre/post changes in outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sees patient at an eligible primary care clinic
- •Speaks and understands English
- •Age 18 or older
- •Identifies as a pediatrician, nurse practitioner, physician assistant (pediatric primary care healthcare provider)
- •Adolescents
- •Age 12 to 16
- •Attending an upcoming well-child visit from a provider enrolled in the study
- •Caregiver who is accompanying well-child visit with adolescent is also participating
- •Speaks and understands English
- •Is parent or primary caregiver for an adolescent age 12 to 16
- •Adolescent has an upcoming well-child visit with a provider enrolled in the study
- •Accompanying child to the well-visit
- •Adolescent is interested and eligible to participate in study
- •Speaks and understand English
排除标准
- •Unable to assent/consent
- •Does not meet inclusion criteria
研究组 & 干预措施
Engaging Together for Healthy Relationships
Providers and families in the intervention arm will receive the ETHR program which includes a clinician training, provider scripts, resource guides, a take home box for families, post-visit text messages, a comprehensive website, and warm referral processes.
干预措施: Engaging Together for Health Relationships (Behavioral)
结局指标
主要结局
Percentage of participants who complete the 1-month post-intervention survey out of the total who consented
时间窗: 4 months
Through completion of completing 1- month post-intervention survey, an average of 8 months
Percentage of participants who are eligible out of the total who are approached
时间窗: Through completion of study recruitment, an average of 6 months
Will assess through tracking data
Percentage of participants who are consented out of the total who are eligible
时间窗: Through completion of study recruitment, an average of 6 months
Will assess through tracking data
Percentage of participants who complete the baseline survey out of the total who consented
时间窗: Through completion of completing baseline surveys, an average of 6 months
Will assess through tracking data
Percentage of participants who complete the well-visit out of the total who consented
时间窗: Through completion of completing well-visits, an average of 6 months
Will assess through tracking data
Percentage of participants who complete the immediate post-intervention survey out of the total who consented
时间窗: Through completion of completing post-intervention survey, an average of 7 months
Will assess through tracking data
Percentage of participants who complete the 3-month post-intervention survey out of the total who consented
时间窗: Through completion of completing 3 month post-intervention survey, an average of 12 months
Will assess through tracking data
Percentage of participants who strongly agree or agree that the intervention is acceptable using a 4-item validated measure (Acceptability of Intervention Measure)
时间窗: Through completion of completing immediate post-visit surveys, an average of 6 months
Validated measure (Acceptability of Intervention Measure)
Percent of participants who received intervention during pediatric primary care visit
时间窗: Through completion of completing well-visits, an average of 6 months
Investigator-developed measure with questions about what components of the intervention were received during the well visit
Participants use intervention resources after the visit
时间窗: Through completion of intervention, on average 3 months post well visit
Investigator-developed measure on use of intervention resources after the visit
次要结局
- ARA knowledge(baseline, 3 months surveys (6 months total))
- Self-efficacy in preventing adolescent relationship abuse (ARA), change in outcome between baseline and 3 months(Baseline, 3-month post intervention)
- Percentage of participants who utilize ARA resources at each measurement point, change in outcome over time(Baseline, 1 month post intervention, 3 month post-intervention)
- Attitudes about ARA, change in outcome between baseline and 3 months(Baseline, 3-month post intervention)
- Motivation around preventing dating violence(Baseline, 3-month post intervention)
- Parent-adolescent communication around dating and ARA, change in outcome over time(Baseline, 3-month post intervention)
- Parental monitoring around dating and ARA, change in outcome over time(Baseline, 3-month post intervention)
- Percentage of adolescents reporting ARA victimization and perpetration(Baseline, 3-month post intervention)
研究者
Maya Ragavan
Assistant Professor
University of Pittsburgh