A Brief MI Intervention in the ED to Increase Child Passenger Restraint Use

October 24, 2016 updated by: Michelle L. Macy, University of Michigan

A Brief Motivational Interviewing Intervention in the Emergency Department to Increase Size-Appropriate Child Passenger Restraint Use

This study involves an emergency department (ED)-based intervention utilizing Motivational Interviewing (MI) techniques and patient-centered (e.g., tailored) print materials to promote the correct and consistent use of size-appropriate child passenger restraints (car seats, booster seats, and seat belts). This study is designed as a randomized pilot trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Motor vehicle collisions (MVCs) remain a leading cause of death among children after the first year of life despite substantial improvements in passenger safety. Deaths and severe injuries from MVCs can be reduced significantly through the consistent use of size-appropriate child passenger restraints. Still, 10% of children ride completely unrestrained and roughly one-quarter do not use the recommended restraint for their size. New approaches are needed to motivate behavior change among parents who do not consistently use size-appropriate passenger restraints for their children from birth through age 10. Emergency department (ED) visits represent unique opportunities to reach vulnerable children and their parents who have difficulty accessing the primary care settings where childhood injury prevention information is commonly provided. Motivational interviewing (MI) in the ED has been used to encourage a variety of health behaviors among at-risk patients. However, MI has not been previously evaluated for child passenger safety promotion programs. This study will involve an ED-based intervention utilizing MI techniques and patient-centered (e.g., tailored) print materials to promote the correct and consistent use of size-appropriate child passenger restraints. This study is designed as a randomized pilot trial of the intervention utilizing a 2x2 factorial design to examine the independent and additive effects of ED-based MI and tailored print materials on the consistent use of size-appropriate child passenger restraints. Aim 1) To assess the feasibility and acceptability of the ED-based intervention among parents of children from birth through age 10; Aim 2) To determine the impact of the intervention on child passenger restraint attitudes and practices at 6-month follow-up in comparison to baseline assessments.

Study Type

Interventional

Enrollment (Actual)

345

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan C.S. Mott Children's Hospital Emergency Department
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be an adult (18+ years) parent or caregiver who regularly drives with their child,
  • are able to speak and read English,
  • who is presenting to the ED with their child age birth to 10 years.
  • Child must be <4'9" in height.

Exclusion Criteria:

  • Adult participants must be able to speak and read English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group1 Baseline+MI+tailored brochure

Participants randomized to Group 1 will receive the motivational interviewing intervention in the ED and will be mailed a tailored educational brochure about child passenger safety.

All participants will complete the baseline assessment survey, a 2 week follow-up phone call and a 6 month follow-up encounter.
Behavioral: Motivational Interviewing
Motivational interviewing (MI) in the ED has been used to encourage a variety of health behaviors among at-risk patients. In this study, researchers will employ motivational interviewing with half of the study participants to investigate the effects of the technique on child passenger restraint behaviors in a population of parents of children birth to 10 years of age.
Behavioral: Tailored brochure
Tailored Print materials will be mailed to half of participants to investigate the effects of using patient-centered educational materials compared with generic educational materials to influence child passenger restraint behaviors in a population of parents of children birth to 10 years of age.
Experimental: Group2 Baseline+MI+general info

Participants randomized to Group 2 will receive the motivational interviewing intervention in the ED and will be mailed a generic educational brochure about child passenger safety.

All participants will complete the baseline assessment survey, a 2 week follow-up phone call and a 6 month follow-up encounter.
Behavioral: Motivational Interviewing
Motivational interviewing (MI) in the ED has been used to encourage a variety of health behaviors among at-risk patients. In this study, researchers will employ motivational interviewing with half of the study participants to investigate the effects of the technique on child passenger restraint behaviors in a population of parents of children birth to 10 years of age.
Experimental: Group3 Baseline+tailored brochure

Participants randomized to Group 3 will receive no intervention in the ED and will be mailed a tailored educational brochure about child passenger safety

All participants will complete the baseline assessment survey, a 2 week follow-up phone call and a 6 month follow-up encounter.
Behavioral: Tailored brochure
Tailored Print materials will be mailed to half of participants to investigate the effects of using patient-centered educational materials compared with generic educational materials to influence child passenger restraint behaviors in a population of parents of children birth to 10 years of age.
No Intervention: Group4 Baseline+general info

Control Group. Participants randomized to this arm will receive no intervention in the ED and will be mailed a generic educational brochure about child passenger safety.

All participants will complete the baseline assessment survey, a 2 week follow-up phone call and a 6 month follow-up encounter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of size-appropriate restraint
Time Frame: 6 month follow up
At the 6-month follow-up encounter, we will reassess the child's current passenger restraint use. We will measure the impact of the intervention on use of a size-appropriate restraint for the child.
6 month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transition at the recommended time
Time Frame: 6 month follow up
At the 6-month follow-up encounter, we will measure the impact of the intervention on the appropriateness of the transition to the next restraint.
6 month follow up
Change in sub-optimal restraint use
Time Frame: 6 month follow up
We will determine change from baseline to 6-month follow-up in parent's report of allowing sub-optimal restraint use (e.g., unrestrained, premature transition to a less protective restraint).
6 month follow up
Acceptability of the intervention (composite measure)
Time Frame: 2 week follow up

Participants will be asked to provide impressions of acceptability of the intervention by rating the following:

  • quality of educational information received in relation to the study
  • amount of time spent reviewing study educational materials
  • amount of information shared with family/friends
  • acceptability of initiating the intervention in the ED
2 week follow up
Acceptability of the intervention (composite measure)
Time Frame: 6 month follow up

Participants will be asked to provide impressions of acceptability of the intervention by rating the following:

  • quality of educational information received in relation to the study
  • amount of time spent reviewing study educational materials
  • amount of information shared with family/friends
  • acceptability of initiating the intervention in the ED
6 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Hurley Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

July 6, 2015

First Submitted That Met QC Criteria

July 9, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • HUM00096047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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