Evaluating Models for Dissemination of Injury Prevention Information in the Pediatric Emergency Department Setting
Primary Purpose
Car Seats, Injuries
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Standard Care (ESC)
Brief Motivational Intervention (BMI)
Sponsored by
About this trial
This is an interventional prevention trial for Car Seats focused on measuring child safety restraint, injury prevention, automotive
Eligibility 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
Sites / Locations
- Hasbro Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Enhanced Standard Care
Motivational Intervention
Arm Description
Instructional materials
Motivational interview
Outcomes
Primary Outcome Measures
Self-reported child safety restraint practices, attitudes and knowledge
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00476255
Brief Title
Evaluating Models for Dissemination of Injury Prevention Information in the Pediatric Emergency Department Setting
Official Title
Evaluating Models for Dissemination of Injury Prevention Information in the PED
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Withdrawn
Why Stopped
Unfunded
Study Start Date
December 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rhode Island Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Car Seats, Injuries
Keywords
child safety restraint, injury prevention, automotive
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced Standard Care
Arm Type
Active Comparator
Arm Description
Instructional materials
Arm Title
Motivational Intervention
Arm Type
Experimental
Arm Description
Motivational interview
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Standard Care (ESC)
Intervention Description
Reading material
Intervention Type
Behavioral
Intervention Name(s)
Brief Motivational Intervention (BMI)
Intervention Description
Motivational interview with trained therapist
Primary Outcome Measure Information:
Title
Self-reported child safety restraint practices, attitudes and knowledge
Time Frame
3 months post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James G Linakis, PhD, MD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasbro Children's Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluating Models for Dissemination of Injury Prevention Information in the Pediatric Emergency Department Setting
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