Brief Primary Care Intervention Helps Parents With Discipline

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seth Scholer, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00875303
First received: April 1, 2009
Last updated: October 27, 2011
Last verified: October 2011
  Purpose

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: Open Label
Primary Purpose: Health Services Research
Official Title: Brief Primary Care Intervention Helps Parents With Discipline

Resource links provided by NLM:


Further study details as provided by 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parents' report of number of minutes of discussion between physician and parent about childhood behavior or discipline. [ Time Frame: Same day ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875303

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

Additional Information:
Publications:
Additional 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
Study First Received: April 1, 2009
Last Updated: October 27, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014