The Seatbelt Intervention Study

NCT ID: NCT02258633

Last Updated: 2014-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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High Risk Population of Part-time Seatbelt Users

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervener Brief Intervention (IBI)

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.

Group Type EXPERIMENTAL

Interactive interview and tailored family centered seatbelt safety intervention

Intervention Type OTHER

Enhanced Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Interactive interview and tailored family centered seatbelt safety intervention

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Peter Ehrlich

Co-Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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HUM00026025

Identifier Type: -

Identifier Source: org_study_id

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