Viewing Study NCT00056940



Ignite Creation Date: 2024-05-05 @ 11:29 AM
Last Modification Date: 2024-10-26 @ 9:08 AM
Study NCT ID: NCT00056940
Status: COMPLETED
Last Update Posted: 2007-04-24
First Post: 2003-03-26

Brief Title: Prevention of Violent Behavior Among Children
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization: Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD

Study Overview

Official Title: Randomized Controlled Trial to Prevent Child Violence
Status: COMPLETED
Status Verified Date: 2007-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Violence is one of the major causes of death and injury for children adolescents and young adults 10 to 25 years of age This study will examine the effectiveness of a violence prevention program in pediatricians offices The program is designed for families who bring their 2 to 11 year old children in for a well child exam It focuses on helping parents change behaviors related to the development of violent behavior in children
Detailed Description: More children die violence-related deaths each year than from all natural causes combined In 2002 the World Health Organization WHO reported that 16 million people worldwide died from violence in the year 2000 half of these deaths were due to suicides one-third were due to homicides and only one-fifth were war related The United States continues to have the highest number of violence-related deaths of all developed countries

The WHO has reviewed the effectiveness of worldwide intervention strategies and made recommendations to promote violence prevention throughout the world Some of the common themes across all countries included 1 because families play a fundamental role in influencing the propensity for violent behavior efforts to provide parents with information and strategies for raising nonviolent children are needed and 2 early interventions to reduce childhood exposure to violence are essential

In this study Wake Forest University Health Sciences WFUHS and the American Academy of Pediatrics AAP will collaborate to evaluate the effectiveness of a pediatric clinicians intervention that has been extensively pilot tested Pediatric Research in Office Settings PROS a program of the AAP is a national network of practice-based clinicians experienced in research participation PROS membership consists of more than 697 practices and 1674 clinicians across the country in 60 AAP Chapters

This study is being conducted in primary care pediatric clinics across the country that participate in the PROS network

PROS practices were randomly assigned to either Group 1 violence prevention intervention or Group 2 literacy promotion effort The study included a total of 137 clinics across the country 242 practitioners and 4890 patients ages 2 to 11 years old Group 1 providers received a community violence prevention resource worksheet to help them identify community specific assets Patient families parentlegal guardian received tools to help them adhere to provider recommendations Providers were trained to apply brief techniques of motivational interviewing to help ascertain patient-centered motivation to change violence-related behaviors Patient families knowledge attitudes and self-reported behaviors were examined prior to the well child exam and at 1 and 6 months after the well child exam Baseline data were collected in the waiting room the data forms took 10 minutes to complete Follow-up telephone interviews were conducted at 1 and 6 months and took 10 minutes to complete

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None