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Clinical Trials/NCT03058861
NCT03058861
Completed
N/A

Mitigating ACEs in Pediatric Primary Care

Vanderbilt University Medical Center1 site in 1 country576 target enrollmentJanuary 18, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Violence
Sponsor
Vanderbilt University Medical Center
Enrollment
576
Locations
1
Primary Endpoint
Change from baseline Parenting Survey at 2 months
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 18, 2017
End Date
January 3, 2018
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Seth Scholer

Associate Professor of Pediatrics

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change from baseline Parenting Survey at 2 months

Time Frame: Baseline and 2 months

Parenting Survey: 12 item scale that assesses parenting behaviors.

Secondary Outcomes

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

Study Sites (1)

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