NCT04160013

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
533

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 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

October 16, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

1.1 years

First QC Date

November 7, 2019

Last Update Submit

December 17, 2024

Conditions

ParentingViolenceChild Abuse

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Discipline education

EXPERIMENTAL

Education about discipline using the Play Nicely program (www.playnicely.org).

Behavioral: Discipline education

Cavity prevention

PLACEBO COMPARATOR

Education about cavity prevention using a 2 page handout.

Behavioral: Cavity Prevention

Interventions

Discipline educationBEHAVIORAL

Discipline education using the Play Nicely program.

Discipline education
Cavity PreventionBEHAVIORAL

Cavity prevention using a 2 page handout.

Cavity prevention

Eligibility Criteria

Age6 Months - 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics and Principal Investigator

Study Record Dates

First Submitted

November 7, 2019

First Posted

November 12, 2019

Study Start

October 16, 2017

Primary Completion

November 5, 2018

Study Completion

January 19, 2019

Last Updated

December 19, 2024

Record last verified: 2024-12

Locations

US(1)