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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00875303
Other study ID # PN Feb 2008
Secondary ID
Status Completed
Phase N/A
First received April 1, 2009
Last updated October 27, 2011
Start date June 2008
Est. completion date July 2008

Study information

Verified date October 2011
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 258
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


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.
Control
Routine primary care.

Locations

Country Name City State
United States Vanderbilt Pediatric Primary Care Clinic Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (7)

Scholer SJ, Brokish PA, Mukherjee AB, Gigante J. A violence-prevention program helps teach medical students and pediatric residents about childhood aggression. Clin Pediatr (Phila). 2008 Nov;47(9):891-900. doi: 10.1177/0009922808319965. Epub 2008 Jul 14. — View Citation

Scholer SJ, Cherry R, Garrard HG 4th, Gupta AO, Mace R, Greeley N. A multimedia program helps parents manage childhood aggression. Clin Pediatr (Phila). 2006 Nov;45(9):835-40. — View Citation

Scholer SJ, Hudnut-Beumler J, Dietrich MS. A brief primary care intervention helps parents develop plans to discipline. Pediatrics. 2010 Feb;125(2):e242-9. doi: 10.1542/peds.2009-0874. Epub 2010 Jan 18. — View Citation

Scholer SJ, Hudnut-Beumler J, Dietrich MS. The effect of physician--parent discussions and a brief intervention on caregivers' plan to discipline: is it time for a new approach? Clin Pediatr (Phila). 2011 Aug;50(8):712-9. doi: 10.1177/0009922811400730. Ep — View Citation

Scholer SJ, Mukherjee AB, Gibbs KI, Memon S, Jongeward KL. Parents view a brief violence prevention program in clinic. Clin Pediatr (Phila). 2007 Oct;46(8):724-34. Epub 2007 Jul 19. — View Citation

Scholer SJ, Nix RL, Patterson B. Gaps in pediatricians' advice to parents regarding early childhood aggression. Clin Pediatr (Phila). 2006 Jan-Feb;45(1):23-8. — View Citation

Scholer SJ, Walkowski CA, Bickman L. Voluntary or required viewing of a violence prevention program in pediatric primary care. Clin Pediatr (Phila). 2008 Jun;47(5):461-8. doi: 10.1177/0009922807311731. Epub 2008 Jan 23. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary As a result of the well child visit, parents' plans to change how they discipline their children. Same day as well child visit. No
Secondary Parents' report of number of minutes of discussion between physician and parent about childhood behavior or discipline. Same day No
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