Brief Primary Care Intervention Helps Parents With Discipline

October 27, 2011 updated by: Seth Scholer, Vanderbilt University
Play Nicely, is a 40 minute, interactive, media-rich, CD ROM that teaches parents, health care professionals, counselors, and child care workers/teachers the basics in aggression management for children ages 1-7. For more information about the program and to review results of previous studies, see www.playnicely.org. The objective of this study is to determine if using this brief intervention during the well child visit can affect parents' plans to discipline their children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

258

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Pediatric Primary Care Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • English or Spanish speaking parents of 1-5 year old children presenting to the Vanderbilt Primary Care Clinic for a well child visit.

Exclusion Criteria:

  • Caregiver could not speak English or Spanish.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Routine primary care.
Behavioral: Control
Routine primary care.
Experimental: Multimedia intervention
Behavioral: Play Nicely program
The intervention was the Play Nicely program, a multimedia educational program. Permission to demonstrate the program to multiple viewers was obtained from the copyright holder. English speaking caregivers viewed the 2nd English language edition and Spanish speaking caregivers viewed the Spanish edition. In the program, there are 16 options (20 options in the Spanish version) to respond to the hypothetical situation of witnessing a young child have hurtful behavior toward another child. Caregivers in the intervention group were instructed to view 4 of the interactive options of their choosing. On average, it takes 1 minute to view one option. Parents in the control group received routine primary care with their pediatrician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
As a result of the well child visit, parents' plans to change how they discipline their children.
Time Frame: Same day as well child visit.
Same day as well child visit.

Secondary Outcome Measures

Outcome Measure
Time Frame
Parents' report of number of minutes of discussion between physician and parent about childhood behavior or discipline.
Time Frame: Same day
Same day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

April 1, 2009

First Submitted That Met QC Criteria

April 2, 2009

First Posted (Estimate)

April 3, 2009

Study Record Updates

Last Update Posted (Estimate)

October 28, 2011

Last Update Submitted That Met QC Criteria

October 27, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PN Feb 2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Discipline

Clinical Trials on Control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe