- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00476255
Evaluating Models for Dissemination of Injury Prevention Information in the Pediatric Emergency Department Setting
November 5, 2014 updated by: Rhode Island Hospital
Evaluating Models for Dissemination of Injury Prevention Information in the PED
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Hasbro Children's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Enhanced Standard Care
Instructional materials
|
Reading material
|
Experimental: Motivational Intervention
Motivational interview
|
Motivational interview with trained therapist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self-reported child safety restraint practices, attitudes and knowledge
Time Frame: 3 months post intervention
|
3 months post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James G Linakis, PhD, MD, Rhode Island Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
May 18, 2007
First Submitted That Met QC Criteria
May 18, 2007
First Posted (Estimate)
May 21, 2007
Study Record Updates
Last Update Posted (Estimate)
November 7, 2014
Last Update Submitted That Met QC Criteria
November 5, 2014
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0080-06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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