Clinical trial NCT02496481: A Brief MI Intervention in the ED to Increase Child Passenger Restraint Use
Official title: A Brief Motivational Interviewing Intervention in the Emergency Department to Increase Size-Appropriate Child Passenger Restraint Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Restraint Systems
Seat Belts
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Hurley Medical Center
First posted: 2015-07-14
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Use of size-appropriate restraint
timeFrame: 6 month follow up
Secondary outcomes:
measure: Transition at the recommended time
timeFrame: 6 month follow up
measure: Change in sub-optimal restraint use
timeFrame: 6 month follow up
measure: Acceptability of the intervention (composite measure)
timeFrame: 2 week follow up
measure: Acceptability of the intervention (composite measure)
timeFrame: 6 month follow up
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan C.S. Mott Children's Hospital Emergency Department
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center Emergency Department
state: Michigan
Study officials:
References: