The Seatbelt Intervention Study

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT02258633

Collaborator

(none)

200

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
High Risk Population of Part-time Seatbelt Users	Other: Interactive interview and tailored family centered seatbelt safety intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Brief Tailored Family-centered Seatbelt Intervention for Hospitalized Trauma

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Interactive interview and tailored family centered seatbelt safety intervention
No Intervention: Enhanced Usual Care Subjects and parents will receive standard trauma care, plus complete brief questionnaires and receive general safety information.

Arm

Intervention/Treatment

Experimental: 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.

Other: Interactive interview and tailored family centered seatbelt safety intervention

No Intervention: Enhanced Usual Care

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

Outcome Measures

Primary Outcome Measures

Seat belt use [1 month]
Follow up telephone assessment on full time seat belt use by parent and child
Seat belt knowledge [1 month]
Follow up telephone assessment on level of knowledge of seat belt use and risk factors
Attitudes [1 month]
Follow up telephone assessment of positive attitude, motivation, and self-efficacy regarding safety restraint use.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 14 Years

Sexes Eligible for Study:

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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Michigan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peter Ehrlich, Co-Principal Investigator, University of Michigan

ClinicalTrials.gov Identifier:

NCT02258633

Other Study ID Numbers:

HUM00026025

First Posted:

Oct 7, 2014

Last Update Posted:

Oct 7, 2014

Last Verified:

Oct 1, 2014

Study Results

No Results Posted as of Oct 7, 2014