Mitigating ACEs in Pediatric Primary Care

NCT ID: NCT03058861

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 576 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-18
• Study Completion Date: 2018-01-03

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.

Conditions

Violence; Parenting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Discipline education - Play Nicely program

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.

Group Type: EXPERIMENTAL

Play Nicely Program

Intervention Type: BEHAVIORAL

Play Nicely multimedia program and handbook that provides education about healthy discipline strategies.

Control Group

Routine primary care will be provided.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Play Nicely Program

Play Nicely multimedia program and handbook that provides education about healthy discipline strategies.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Seth Scholer

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seth Scholer, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt Pediatric Primary Care Clinic

Nashville, Tennessee, United States

Countries

United States

References

Sausen KA, Randolph JW, Casciato AN, Dietrich MS, Scholer SJ. The Development, Preliminary Validation, and Clinical Application of the Quick Parenting Assessment. Prev Sci. 2022 Feb;23(2):306-320. doi: 10.1007/s11121-021-01320-w. Epub 2021 Nov 15.

Reference Type: RESULT

PMID: 34780005 (View on PubMed)

Other Identifiers

IRB#161987

Identifier Type: -

Identifier Source: org_study_id