Brief Primary Care Intervention Helps Parents With Discipline
This study has been completed.
Sponsor:
Vanderbilt University
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
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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 |
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 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 May 19, 2013