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Clinical Trials/NCT02258633
NCT02258633CompletedNot Applicable

A Brief Tailored Family-centered Seatbelt Intervention for Hospitalized Trauma

University of Michigan0 sites200 target enrollmentStarted: March 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
200
Primary Endpoint
Attitudes

Study Overview

Brief Summary

The study will use a randomized controlled design testing the effectiveness of the following intervention: (i) intervener brief intervention (IBI) vs. (ii) Enhanced usual care (EUC). The study will identify children ages 2-14 at a pediatric trauma center. Children and their parents who agree to participate in the study will then complete a screening survey to identify part time seatbelt use. Those who screen positive will complete a more detailed baseline survey and then be randomized to one of two study conditions. At one month, a follow up assessment by telephone will be completed.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
7 Years to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Children ages 7-14 and their parent or guardian, at a pediatric trauma center
  • •Child admitted to hospital with diagnosis of injury other than sexual assault and suicide
  • •Identify as part time seat belt users

Exclusion Criteria

  • Not provided

Arms & Interventions

Intervener Brief Intervention (IBI)

Experimental

Subjects and parents will complete a Brief Motivational Interview (BMI) incorporating personalized feedback, discussion of choices and changes, and therapist led intervention message relating behavioral change and future goals.

Intervention: Interactive interview and tailored family centered seatbelt safety intervention (Other)

Enhanced Usual Care

No Intervention

Subjects and parents will receive standard trauma care, plus complete brief questionnaires and receive general safety information.

Outcomes

Primary Outcomes

Attitudes

Time Frame: 1 month

Follow up telephone assessment of positive attitude, motivation, and self-efficacy regarding safety restraint use.

Seat belt knowledge

Time Frame: 1 month

Follow up telephone assessment on level of knowledge of seat belt use and risk factors

Seat belt use

Time Frame: 1 month

Follow up telephone assessment on full time seat belt use by parent and child

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Peter Ehrlich

Co-Principal Investigator

University of Michigan

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