Pilot Trial of Clinic-based Dating Violence Prevention Program for Adolescents and Caregivers

Официальное название

Engaging Together for Healthy Relationships Version 2.0: Multisite Pilot Intervention Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Engaging Together for Health Relationships
  Dating violence intervention for caregivers and adolescents to be delivered within pediatric primary care

Первичные конечные точки

• Percentage of participants who are eligible out of the total who are approached [Срок оценки: Through completion of study recruitment, an average of 6 months]
• Percentage of participants who are consented out of the total who are eligible [Срок оценки: Through completion of study recruitment, an average of 6 months]
• Percentage of participants who complete the baseline survey out of the total who consented [Срок оценки: Through completion of completing baseline surveys, an average of 6 months]
• Percentage of participants who complete the well-visit out of the total who consented [Срок оценки: Through completion of completing well-visits, an average of 6 months]
• Percentage of participants who complete the immediate post-intervention survey out of the total who consented [Срок оценки: Through completion of completing post-intervention survey, an average of 7 months]
• Percentage of participants who complete the 1-month post-intervention survey out of the total who consented [Срок оценки: 4 months]
• Percentage of participants who complete the 3-month post-intervention survey out of the total who consented [Срок оценки: Through completion of completing 3 month post-intervention survey, an average of 12 months]
• Percentage of participants who strongly agree or agree that the intervention is acceptable using a 4-item validated measure (Acceptability of Intervention Measure) [Срок оценки: Through completion of completing immediate post-visit surveys, an average of 6 months]
• Percent of participants who received intervention during pediatric primary care visit [Срок оценки: Through completion of completing well-visits, an average of 6 months]
• Participants use intervention resources after the visit [Срок оценки: Through completion of intervention, on average 3 months post well visit]

Вторичные конечные точки (8)

• Self-efficacy in preventing adolescent relationship abuse (ARA), change in outcome between baseline and 3 months [Срок оценки: Baseline, 3-month post intervention]
• Percentage of participants who utilize ARA resources at each measurement point, change in outcome over time [Срок оценки: Baseline, 1 month post intervention, 3 month post-intervention]
• Attitudes about ARA, change in outcome between baseline and 3 months [Срок оценки: Baseline, 3-month post intervention]
• Motivation around preventing dating violence [Срок оценки: Baseline, 3-month post intervention]
• Parent-adolescent communication around dating and ARA, change in outcome over time [Срок оценки: Baseline, 3-month post intervention]
• Parental monitoring around dating and ARA, change in outcome over time [Срок оценки: Baseline, 3-month post intervention]
• Percentage of adolescents reporting ARA victimization and perpetration [Срок оценки: Baseline, 3-month post intervention]
• ARA knowledge [Срок оценки: baseline, 3 months surveys (6 months total)]

Критерии участия

Критерии включения

Providers:

• 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

Parents

• 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

Критерии исключения

• Unable to assent/consent
• Does not meet inclusion criteria

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• UPMC Children's Community Practice — Monongahela

Идентификаторы

NCT: NCT07039253 · STUDY25030017 · 1R21HD109627-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗