NCT03058861

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
576

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2018

Completed
Last Updated

December 4, 2025

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

January 26, 2017

Last Update Submit

November 26, 2025

Conditions

ViolenceParenting

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Parenting Survey at 2 months

    Parenting Survey: 12 item scale that assesses parenting behaviors.

    Baseline and 2 months

Secondary Outcomes (1)

  • Change from baseline Attitudes Toward Spanking scale at 2 months

    Baseline and 2 months

Study Arms (2)

Discipline education - Play Nicely program

EXPERIMENTAL

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.

Behavioral: Play Nicely Program

Control Group

NO INTERVENTION

Routine primary care will be provided.

Interventions

Play Nicely ProgramBEHAVIORAL

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

Discipline education - Play Nicely program

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt Pediatric Primary Care Clinic

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • 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.

    PMID: 34780005RESULT

Study Officials

  • Seth Scholer, MD,MPH

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

January 26, 2017

First Posted

February 23, 2017

Study Start

January 18, 2017

Primary Completion

January 3, 2018

Study Completion

January 3, 2018

Last Updated

December 4, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)