跳至主要内容
临床试验/NCT05013138
NCT05013138已完成不适用

Addressing ACEs Among Hispanic Caregivers in a Pediatric Primary Care Population to Improve Child Health and Decrease Early Adversity

Emory University2 个研究点 分布在 1 个国家目标入组 181 人开始时间: 2022年4月29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
181
试验地点
2
主要终点
Number of emergency department (ED) visits documented in chart at 18 months post-intervention

研究概览

简要总结

This longitudinal study will evaluate if increased caregiver awareness of their own ACEs through provider-led discussions will lead to improved child health via fewer emergency department, urgent care visits and missed primary care appointments.

详细描述

This longitudinal study will examine whether screening for caregiver adverse childhood experiences (ACEs) and a provider-led discussion of how exposure to ACEs impacts parenting will improve child health outcomes over an 18 month period compared to treatment as usual in a pediatric primary care setting during infant well-child visits. Child health outcomes examined will be rates of emergency department and urgent care visits. Potential protective factors, including parental warmth and resilience will also be examined. The population being studied will include caregivers to infants (ranging 1 week-18 months) receiving care at Mercy Care Clinic (MCC) in Chamblee, Georgia (GA), which primarily serves Hispanic families. Contact will be made by approaching patients present for an infant well-child visit in the clinic. Informed consent will be obtained by a study staff member in the waiting room of the Mercy Care Chamblee Clinic. Electronic or written consent (in English or Spanish based on patient preference) will be obtained. This is not a no-contact study. Data will not be publicly available, but deidentified data will be available upon request beginning 12 months after the study is completed. Only direct study staff will have access to identifying information for participants. Privacy of existing data is not a concern. Interactions will include participant's filling out surveys (or having surveys read aloud to them in their preferred language) and chart review. Those participants who meet with providers randomized to the ACEs discussion will also have a short discussion with their provider about any experienced ACEs and forms of resilience they note on the surveys. Data will be collected in the clinic setting and for follow-up visits by phone or internet based on participant preference.

Topics assessed will include exposure to adverse experiences in childhood, depression and posttraumatic stress disorder symptoms, resilience, and parenting. Each assessment will take less than one hour to complete. All participants will be given a subject identification (ID) number upon consent and all data will be deidentified and only associated with that ID number for the remainder of the study. Medical records will be examined for appointment confirmation (eligibility) and for infant medical visits over the course of the study (outcome variable) and only study staff will have access to identifiable information.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Caregivers will be eligible to enroll in the study if they bring children to the MCC for either a 4-month, 6-month, 9-month, 15-month, or 18-month WCC. Notably, we anticipate the majority of participants to be of Hispanic origin and many to be exclusively Spanish-speaking. All Research Assistants (RAs) working directly with caregivers will be bilingual according to Emory Spanish fluency testing. We will solicit expert opinion from faculty that work with these communities and the staff of MCC that work with these patients on a regular basis.

排除标准

  • Caregivers will be excluded if they are unable to speak and read either English or Spanish. Caregivers will also be excluded if they have already been enrolled in the study protocol via another child or prior WCC. Caregivers who are under the age of 18 years will also be excluded.

结局指标

主要结局

Number of emergency department (ED) visits documented in chart at 18 months post-intervention

时间窗: 18 months post-intervention

Number of emergency department (ED) visits documented in chart from baseline to 18 months post-intervention

Number or urgent care (UC) visits documented in chart at 18 months post-intervention

时间窗: 18 months post-intervention

Number or urgent care (UC) visits documented in chart from baseline to18 months post-intervention

Number of medical visits at Mercy Care at 18 months post-intervention

时间窗: 18 months post-intervention

Number of medical visits at Mercy Care over the course of the study period will be obtained from baseline to 18 months post-intervention.

次要结局

  • Rate of referrals to Division of Family and Child Services (DFACS) at 18 months post-intervention(18 months post-intervention)
  • Change in Primary Care PTSD score for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) from Baseline Caregiver's PTSD symptoms due to ACEs screening(Baseline, 1 week post-intervention, 6 months follow up, 18 months follow up)
  • Change in Parenting Questionnaire (PQ) warmth subscale (PQ-warmth) score from Baseline(Baseline, 6 months follow up, 18 months follow up)
  • Rate of referrals to non-DFACS services at 18 months post-intervention(18 months post-intervention)
  • Rate of clinic-based social worker visits at 18 months post-intervention(18 months post-intervention)
  • Change in Brief Resilience Scale score from baseline(Baseline, 6 months follow up, 18 months follow up)
  • Attendance at well child check (WCC) visits at 18 months post-intervention(18 months post-intervention)
  • Subjective experience of caregiver ACEs screening on clinic staff at baseline(Baseline)

研究者

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

Abigail Lott

Assistant Professor

Emory University

研究点 (2)

Loading locations...

相似试验