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临床试验/NCT03058861
NCT03058861已完成不适用

Mitigating ACEs in Pediatric Primary Care

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 576 人开始时间: 2017年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
576
试验地点
2
主要终点
Change from baseline Parenting Survey at 2 months

研究概览

简要总结

The project is designed to assess Adverse Childhood Experiences (ACEs) and test a parenting intervention in pediatric primary care.

详细描述

The goal of the project is to affect policy and practice related to Adverse Childhood Experiences (ACEs) screening and intervention in pediatric primary care. First, the investigators will develop and test a new ACEs screening tool that is brief, has a pediatric perspective, builds on parents' strengths, and measures parenting-related ACEs that can be treated. The new ACEs screening tool will measure parenting-related ACEs (e.g. corporal punishment, threatening, humiliation) and family stressors (e.g. divorce, incarceration, mental illness). A research assistant will invite approximately 1000 parents to complete the survey in the Vanderbilt Pediatric Primary Care Clinic. Measures will include child behavior problems that the investigators hypothesize will be associated with elevated parenting scores. The second part of the project will be to recruit English and Spanish-speaking parents for a randomized controlled trial (RCT) to determine if educational interventions can help educate parents about ACEs and decrease parenting-related ACE scores two months post-intervention. In the RCT, the investigators will recruit 300 to 400 parents to participate in the study. Parents in the intervention group will receive 1) a copy of the Play Nicely Healthy Discipline Handbook, 2) information about how to view the Play Nicely multimedia program online and 3) the TN ACEs Handout. Parents in the Control Group will receive routine primary care. Follow up data will be obtained 2 months after enrollment.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parents of 2-10 year old children presenting for a well visit.

排除标准

  • Parents do not speak English, Spanish, or Arabic.

研究组 & 干预措施

Discipline education - Play Nicely program

Experimental

Parents in the intervention group will receive 1) a copy of the Play Nicely Healthy Discipline Handbook (see www.playnicely.org), 2) information about how to view the Play Nicely multimedia program online and 3) the TN ACEs Handout.

干预措施: Play Nicely Program (Behavioral)

Control Group

No Intervention

Routine primary care will be provided.

结局指标

主要结局

Change from baseline Parenting Survey at 2 months

时间窗: Baseline and 2 months

Parenting Survey: 12 item scale that assesses parenting behaviors.

次要结局

  • Change from baseline Attitudes Toward Spanking scale at 2 months(Baseline and 2 months)

研究者

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

Seth Scholer

Associate Professor of Pediatrics

Vanderbilt University Medical Center

研究点 (2)

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