NCT00476255

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed
4.5 years until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Last Updated

November 7, 2014

Status Verified

April 1, 2010

Enrollment Period

2.9 years

First QC Date

May 18, 2007

Last Update Submit

November 5, 2014

Conditions

Car SeatsInjuries

Keywords

child safety restraintinjury preventionautomotive

Outcome Measures

Primary Outcomes (1)

  • Self-reported child safety restraint practices, attitudes and knowledge

    3 months post intervention

Study Arms (2)

Enhanced Standard Care

ACTIVE COMPARATOR

Instructional materials

Behavioral: Enhanced Standard Care (ESC)

Motivational Intervention

EXPERIMENTAL

Motivational interview

Behavioral: Brief Motivational Intervention (BMI)

Interventions

Enhanced Standard Care (ESC)BEHAVIORAL

Reading material

Enhanced Standard Care
Brief Motivational Intervention (BMI)BEHAVIORAL

Motivational interview with trained therapist

Motivational Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • James G Linakis, PhD, MD

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 18, 2007

First Posted

May 21, 2007

Study Start

December 1, 2011

Primary Completion

November 1, 2014

Last Updated

November 7, 2014

Record last verified: 2010-04

Locations

US(1)