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Prevention of Violent Behavior Among Children

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. Identifier: NCT00056940
Recruitment Status : Completed
First Posted : March 27, 2003
Last Update Posted : April 24, 2007
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Condition or disease Intervention/treatment Phase
Behavior Behavioral: Stages of Change Behavioral: Safety Check approach Not Applicable

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 1.6 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 clinician's 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 4,890 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 (parent/legal 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 6600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Trial to Prevent Child Violence
Study Start Date : September 2001
Actual Study Completion Date : July 2006

Primary Outcome Measures :
  1. media use time
  2. discipline techniques used
  3. firearm storage patterns

Secondary Outcome Measures :
  1. knowledge about appropriate media exposure for children
  2. knowledge about appropriate discipline techniques for children
  3. knowledge about appropriate safe firearm storage

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

  • Parent or legal guardian seen in pediatrician's office for well child exam for their 2 to 11 year old children
  • Parent/guardian is with the child the majority of time when the child is at home
  • English or Spanish speaking
  • Anticipate being at the same phone number for 6 to 12 months

Exclusion Criteria

  • Sick child visit
  • One child in family already enrolled
  • No telephone contact information
  • Language other than English or Spanish spoken

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 identifier (NCT number): NCT00056940

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United States, Tennessee
Vanderbilt Universitiy School of Medicine
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Shari Barkin, MD, MSHS Vanderbilt University School of Medicine
Layout table for additonal information Identifier: NCT00056940    
Other Study ID Numbers: 1R01HD42260-1
First Posted: March 27, 2003    Key Record Dates
Last Update Posted: April 24, 2007
Last Verified: April 2007
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Parenting strategies
Media use
Firearm storage