Mitigating ACEs in Pediatric Primary Care: Cohort #2 With 6-24 Month Old Children

The aim is to determine if a brief intervention can affect parents' attitudes about physical punishment and other parenting behaviors.

Study Overview

• Status: Completed
• Conditions: Child Abuse; Parenting; Violence
• Intervention / Treatment: Behavioral: Discipline education; Behavioral: Cavity Prevention

Detailed Description

A public health problem that needs to be solved is how to educate more parents about healthy discipline options. The investigators aim to mitigate adverse childhood experiences (ACEs) by integrating evidence-based parent training into pediatric primary care. Some of the most modifiable ACEs are associated with parenting behaviors that can lead to child abuse. The investigators define unhealthy parenting behaviors such as spanking, threatening, yelling, and humiliation. For adults in the original ACEs study, it was exposure to these behaviors that led to the categorization of child abuse/neglect and that were associated with heart disease, obesity, depression, smoking, drug use, violence, and many other problems. This study may help change policy and practice related to mitigating ACEs in primary care. To accomplish this goal, randomized controlled trials are needed to test brief screening tools and evidence-based resources. A population-based approach is needed to reach all parents (i.e. primary prevention). In the study, parents in the intervention group will receive 3 minutes of education about healthy discipline strategies.

• Study Type: Interventional
• Enrollment (Actual): 533
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Parents of 6 month to 2 year old children presenting to the Vanderbilt Pediatric Primary Care Clinic for a well visit or an acute care visit.

Exclusion Criteria:

• Parents who do not speak and read English, Spanish, or Arabic. The interventions are only available in English, Spanish, and Arabic.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Discipline education; Education about discipline using the Play Nicely program (www.playnicely.org).	Behavioral: Discipline education; Discipline education using the Play Nicely program.
Placebo Comparator: Cavity prevention; Education about cavity prevention using a 2 page handout.	Behavioral: Cavity Prevention; Cavity prevention using a 2 page handout.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attitudes toward spanking	A 10 item scale that assesses parents' attitudes about corporal punishment. The minimum value is 10 and the maximum value is 70. Higher scores indicate a higher likelihood of using spanking.	3-6 months post-enrollment.

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): November 5, 2018
• Study Completion (Actual): January 19, 2019

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 171485

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No