Evaluating Models for Dissemination of Injury Prevention Information in the Pediatric Emergency Department Setting

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2010 by Rhode Island Hospital
Sponsor:
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00476255
First received: May 18, 2007
Last updated: May 4, 2010
Last verified: April 2010
  Purpose

This study examines the Pediatric Emergency Department as a location for increasing safe car seat practices by parents who are not restraining their children appropriately in motor vehicles. Three different intervention will be tested to determine their effectiveness in increasing safe car seat practices: usual emergency department care; provision of printed materials; and a brief motivational intervention in the emergency department.


Condition Intervention
Car Seats
Injuries
Behavioral: Standard Care
Behavioral: Enhanced Standard Care (ESC)
Behavioral: Brief Motivational Intervention (BMI)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluating Models for Dissemination of Injury Prevention Information in the PED

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Self-reported child safety restraint practices, attitudes and knowledge [ Time Frame: 3 months post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 555
Study Start Date: December 2011
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Care
Standard emergency department care
Behavioral: Standard Care
Usual ED care
Active Comparator: Enhanced Standard Care
Instructional materials
Behavioral: Enhanced Standard Care (ESC)
Reading material
Experimental: Motivational Intervention
Motivational interview
Behavioral: Brief Motivational Intervention (BMI)
Motivational interview with trained therapist

Detailed Description:

The long-term goal of the present research program is to enhance the utilization of evidence-based injury prevention strategies and to encourage medical practitioners to disseminate focused information regarding injury prevention in the Pediatric Emergency Department (ED). This study examines the Pediatric Emergency Department as a location for increasing safe car seat practices by parents who are not restraining their children appropriately in motor vehicles. Three different intervention will be tested to determine their effectiveness in increasing safe car seat practices. The proposed research plan: 1. examines the efficacy of a Brief Motivational Intervention to enhance automobile safety restraint-specific injury prevention behaviors in parents/caregivers of younger children; and 2. examines the efficacy of focused, behavior-specific, injury prevention discharge instruction supplements (Enhanced Standard Care) in increasing safety restraint-specific injury prevention behaviors in parents/caregivers of younger children. We will conduct a randomized, controlled trial of parent/caregivers of children being evaluated in the Hasbro Children's Hospital Emergency Department in Providence, Rhode Island. Eligible, consenting participants will be screened with an injury assessment tool for inappropriate use of motor vehicle child safety restraints. High risk participants will be randomized into three intervention groups: Standard Care (SC), Enhanced Standard Care (ESC) and Brief Motivational Intervention (BMI). All participants will then be contacted three months following enrollment and surveyed regarding child safety restraint practices, attitudes and knowledge. The following main effects will be evaluated with relation to child safety restraint practice and attitude change: 1. Intervention (SC vs. ESC vs. BMI); 2. Injury status of child (Injured vs. non-injured). In addition, we will monitor re-injury rates of the index children of all enrolled parent/caregivers for one year from the time of enrollment and compare on the bases of the above main effects.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parents/primary caregivers of children ages 0-7 years who are being seen in the Pediatric ED for a non life-threatening injury or non-injury related complaint
  • Parents/primary caregivers whose children are medically stable
  • Parent/primary caregiver has legal custody of the index child and is able to provide informed consent for participation
  • Parent/primary caregiver speaks English or Spanish
  • Parent/primary caregiver must have access to a motor vehicle in which the child is transported

Exclusion Criteria:

  • parents/primary caregivers who are cognitively unable to take part in the intervention
  • those whose children are suspected by the clinical staff of being victims of child abuse
  • those whose children are medically or surgically unstable
  • those whose children are being evaluated for possible psychiatric disorders or suicidal ideation
  • those who do not speak English or Spanish, and those without a telephone
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476255

Contacts
Contact: James G Linakis, PhD, MD 401-444-6680 James_Linakis_PhD@brown.edu

Locations
United States, Rhode Island
Hasbro Children's Hospital Not yet recruiting
Providence, Rhode Island, United States, 02903
Contact: James G Linakis, PhD, MD    401-444-6680    James_Linakis_PhD@brown.edu   
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: James G Linakis, PhD, MD Rhode Island Hospital
  More Information

No publications provided

Responsible Party: James G. Linakis, PhD, MD, Principal Investigator, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00476255     History of Changes
Other Study ID Numbers: 0080-06
Study First Received: May 18, 2007
Last Updated: May 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
child safety restraint
injury prevention
automotive

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on July 24, 2014