CClinicalTrials.gg
CompletedNCT00056940Updated Apr 24, 2007

Prevention of Violent Behavior Among Children

An interventional study of Stages of Change and Safety Check approach in Behavior, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-04-24.

Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
6,600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Behavior

Keywords

  • Prevention
  • Parenting strategies
  • Media use
  • Discipline
  • Firearm storage
03

In context

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 416 studies on the registry; 25 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria

  • Sick child visit
  • One child in family already enrolled
  • No telephone contact information
  • Language other than English or Spanish spoken
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
6,600 participants

Interventions

  • BehavioralStages of Change
  • BehavioralSafety Check approach
06

What researchers measure

Primary outcomes

  1. media use time

  2. discipline techniques used

  3. firearm storage patterns

Secondary outcomes

  1. knowledge about appropriate media exposure for children

  2. knowledge about appropriate discipline techniques for children

  3. knowledge about appropriate safe firearm storage

07

Study locations

1 site
  • Vanderbilt Universitiy School of Medicine
    Nashville, Tennessee 37232, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00056940
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted
Mar 27, 2003
Start date
Sep 2001
Completion
Jul 2006
Last update
Apr 24, 2007

Study contacts

Shari Barkin, MD, MSHS
principal investigator · Vanderbilt University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion