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

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04160013
Collaborator
(none)
533
1
2
15.1
35.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Discipline education
  • Behavioral: Cavity Prevention
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
533 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
None (Open Label)
Masking Description:
No masking.
Primary Purpose:
Prevention
Official Title:
Mitigating ACEs in Pediatric Primary Care: Cohort #2 With 6-24 Month Old Children
Actual Study Start Date :
Oct 16, 2017
Actual Primary Completion Date :
Nov 5, 2018
Actual Study Completion Date :
Jan 19, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Attitudes toward spanking [3-6 months post-enrollment.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt University Medical Center Nashville Tennessee United States 37232

Sponsors and Collaborators

  • Vanderbilt University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seth Scholer, Professor of Pediatrics and Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT04160013
Other Study ID Numbers:
  • 171485
First Posted:
Nov 12, 2019
Last Update Posted:
Nov 27, 2019
Last Verified:
Nov 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 27, 2019