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Completed

NCT Number: NCT02496481

A Brief MI Intervention in the ED to Increase 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan C.S. Mott Children's Hospital Emergency Department, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing

Behavioral

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.

Tailored brochure

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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
  4. 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Hurley Medical Center

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 14, 2015
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.