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Brief Primary Care Intervention Helps Parents With Discipline

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 3, 2009
Last Update Posted: October 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Vanderbilt University Medical Center
Information provided by (Responsible Party):
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.

Condition Intervention
Discipline Behavioral: Play Nicely program Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Brief Primary Care Intervention Helps Parents With Discipline

Further study details as provided by Seth Scholer, Vanderbilt University:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • Parents' report of number of minutes of discussion between physician and parent about childhood behavior or discipline. [ Time Frame: Same day ]

Enrollment: 258
Study Start Date: June 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875303

United States, Tennessee
Vanderbilt Pediatric Primary Care Clinic
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Vanderbilt University Medical Center
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seth Scholer, Associate Professor of Pediatrics, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00875303     History of Changes
Other Study ID Numbers: PN Feb 2008
First Submitted: April 1, 2009
First Posted: April 3, 2009
Last Update Posted: October 28, 2011
Last Verified: October 2011

Keywords provided by Seth Scholer, Vanderbilt University:
Parents' plans to discipline their children