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临床试验/NCT05880979
NCT05880979已完成不适用

Engaging Together for Healthy Relationships: A Pilot Trial to Test a Brief Dating Violence Prevention Intervention for Pediatric Primary Care

University of Pittsburgh4 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
4
主要终点
Percentage of participants who complete the baseline survey out of the total who consented

研究概览

简要总结

The goal of this pilot randomized clinical trial is to assess feasibility and acceptability of a brief parent-adolescent dating violence prevention intervention (Engaging Together for Healthy Relationships; ETHR) delivered in pediatric primary care settings. The main questions it aims to answer is if ETHR is acceptable and feasible. 4 healthcare providers will receive ETHR to share with their patients which includes clinician training, provider-delivered scripts, resource guides, and a comprehensive website. This will be compared to providers conducting routine well-child care with their patients.

详细描述

The investigators are conducting a pilot randomized clinical trial to test a brief parent-adolescent dating violence prevention intervention (Engaging Together for Healthy Relationships; ETHR). ETHR has been developed for parents and adolescents, to be implemented within pediatric primary care settings. ETHR is a comprehensive intervention which includes a training for clinicians, brief educational scripts for providers, resource guides for the adolescent, parent, and dyad, a comprehensive website, and warm referral processes to connect families with local resources. The investigators will be comparing ETHR with routine care. The specific goal of the pilot trial is to test trial feasibility, as well as intervention acceptability and fidelity. The investigators also will be examining exploratory changes in secondary outcomes and early implementation barriers and facilitators.

Four pediatric clinics will participate in this study. The investigator will recruit two providers from each clinic and randomize them into the intervention provider or control provider. The intervention provider will receive ETHR and the control provider will complete their regular well-child care. The investigators will enroll 15 families in the intervention arm and 5 in the control arm (3:1 enrollment). Families who are seeing the intervention provider for a well-child visit will be enrolled in the intervention arm; those seeing the control provider will be enrolled in the control arm. Families will be eligible if they are seeing the intervention or control providers for a well child visit, if the adolescent coming for the well-visit is between 11 to 15, if both the caregiver and adolescent are interested in participating, and if the family speaks and understands English. Families will be called 2 weeks ahead of their visit to enroll, consent, and complete a baseline survey (both the adolescent and parent will complete the survey). Participants will then attend their well -visit (where they will receive ETHR or routine care, depending on their provider). They will complete an acceptability and fidelity survey immediately post-visit, a resource utilization survey 1 month post visit, and a follow up survey (identical to the baseline survey) 3 months post visit. Providers will complete a brief fidelity and acceptability survey after each study visit (15 for intervention providers, 5 for control providers). All providers and a subset of families enrolled in the intervention arm (20 dyads, 40 participants) will also complete post-intervention interviews.

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 (Participant)

盲法说明

Participants will be told in the consent form that they may receive information about dating violence during their well-visit or they may not. They will not be specifically told if their provider is the intervention provider or control provider.

入排标准

年龄范围
11 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

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 11 to 15
  • 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 11 to 15
  • 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

  • Does not need inclusion criteria

结局指标

主要结局

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 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 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 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)

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

次要结局

  • Self-efficacy in preventing adolescent relationship abuse (ARA), change in outcome between baseline and 3 months(Baseline, 3-month post intervention)
  • Parent-adolescent communication 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)
  • 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)
  • Parental monitoring around dating and ARA, change in outcome over time(Baseline, 3-month post intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maya Ragavan

Assistant Professor of Pediatrics

University of Pittsburgh

研究点 (4)

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