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

Study Overview
=================
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.

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

Conditions
-----------------
Child Restraint Systems, Seat Belts

Intervention / Treatment
-----------------
* Behavioral: Motivational Interviewing
* Behavioral: Tailored brochure


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group1 Baseline+MI+tailored brochure<br>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<br>* 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.<br>Behavioral: Tailored brochure<br>* 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.<br>|
| Experimental: Group2 Baseline+MI+general info<br>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<br>* 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.<br>|
| Experimental: Group3 Baseline+tailored brochure<br>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<br>* 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.<br>|
| No Intervention: Group4 Baseline+general info<br>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 | 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 | 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 | 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) | 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) | 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 |