AzTrials
AzTrials

BehaviorNCT00056940

Prevention of Violent Behavior Among Children

A study testing Stages of Change and Safety Check approach in people with Behavior, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Behavior
What is being tested?
Stages of Change and Safety Check approach
How many people
6,600 participants
Where
1 siteUnited States
Study dates
Sep 2001to Jul 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Vanderbilt Universitiy School of Medicine

    Nashville, Tennessee, 37232

Other trials in United States

About this study

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.

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.

Conditions
Behavior
Being tested
Stages of Change, Safety Check approach
Keywords
Prevention, Parenting strategies, Media use, Discipline, Firearm storage
Medical subject headings
Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stages of ChangeBehavioural

  • Safety Check approachBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. media use time

  2. discipline techniques used

  3. firearm storage patterns

Secondary outcomes (3)
  1. knowledge about appropriate media exposure for children

  2. knowledge about appropriate discipline techniques for children

  3. knowledge about appropriate safe firearm storage

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2003 (estimated)
  2. Study startSep 2001
  3. Study completionJul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
6,600 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00056940
Sponsor's protocol ID
1R01HD42260-1
Other IDs
1R01HD042260
Status last verified
Apr 2007
First submitted
26 Mar 2003
Last updated
24 Apr 2007
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Stages of Change and Safety Check approach in people with Behavior, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

media use time. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2007.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in