Mitigating ACEs in Pediatric Primary Care

Parenting Clinical Trial

Official title:

Mitigating ACEs in Pediatric Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058861
• Other study ID #: IRB#161987
• Status: Completed
• Phase: N/A
• Start date: January 18, 2017
• Est. completion date: January 3, 2018

Study information

• Verified date: February 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 576
• Est. completion date: January 3, 2018
• Est. primary completion date: January 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Parenting
• Violence

Intervention

Behavioral:
• Play Nicely Program
Play Nicely multimedia program and handbook that provides education about healthy discipline strategies.

Locations

Country	Name	City	State
United States	Vanderbilt Pediatric Primary Care Clinic	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Parenting Survey at 2 months	Parenting Survey: 12 item scale that assesses parenting behaviors.	Baseline and 2 months
Secondary	Change from baseline Attitudes Toward Spanking scale at 2 months	Attitudes Toward Spanking scale	Baseline and 2 months