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

NCT ID: NCT02496481

Last Updated: 2016-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 345 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-04-30

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.

Conditions

Child Restraint Systems; Seat Belts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Motivational Interviewing

Intervention Type: 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

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Motivational Interviewing

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Tailored brochure

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hurley Medical Center

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Michelle L. Macy

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Michigan C.S. Mott Children's Hospital Emergency Department

Ann Arbor, Michigan, United States

Hurley Medical Center Emergency Department

Flint, Michigan, United States

Countries

United States

Other Identifiers

HUM00096047

Identifier Type: -

Identifier Source: org_study_id