The Seatbelt Intervention Study

A Brief Tailored Family-centered Seatbelt Intervention for Hospitalized Trauma

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 Overview

• Status: Completed
• Conditions: High Risk Population of Part-time Seatbelt Users
• Intervention / Treatment: Other: Interactive interview and tailored family centered seatbelt safety intervention

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: October 2, 2014
• First Submitted That Met QC Criteria: October 6, 2014
• First Posted (Estimate): October 7, 2014

Study Record Updates

• Last Update Posted (Estimate): October 7, 2014
• Last Update Submitted That Met QC Criteria: October 6, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: HUM00026025