Behavior Clinical Trial
Official title:
Randomized Controlled Trial to Prevent Child Violence
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Diagnostic
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