Evaluating Models for Dissemination of Injury Prevention Information in the Pediatric Emergency Department Setting
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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 |
- 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 |
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| Contact: James G Linakis, PhD, MD | 401-444-6680 | James_Linakis_PhD@brown.edu |
| 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 | |
| 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 |
ClinicalTrials.gov processed this record on May 21, 2013