A Brief MI Intervention in the ED to Increase Child Passenger Restraint Use
A Brief Motivational Interviewing Intervention in the Emergency Department to Increase Size-Appropriate Child Passenger Restraint Use
1 other identifier
interventional
345
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 6, 2015
CompletedFirst Posted
Study publicly available on registry
July 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedOctober 25, 2016
October 1, 2016
10 months
July 6, 2015
October 24, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Transition at the recommended time
6 month follow up
Change in sub-optimal restraint use
6 month follow up
Acceptability of the intervention (composite measure)
2 week follow up
Acceptability of the intervention (composite measure)
6 month follow up
Study Arms (4)
Group1 Baseline+MI+tailored brochure
EXPERIMENTALParticipants 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.
Group2 Baseline+MI+general info
EXPERIMENTALParticipants 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.
Group3 Baseline+tailored brochure
EXPERIMENTALParticipants 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.
Group4 Baseline+general info
NO INTERVENTIONControl 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Adult participants must be able to speak and read English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Hurley Medical Centercollaborator
Study Sites (2)
University of Michigan C.S. Mott Children's Hospital Emergency Department
Ann Arbor, Michigan, 48109, United States
Hurley Medical Center Emergency Department
Flint, Michigan, 48503, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 6, 2015
First Posted
July 14, 2015
Study Start
June 1, 2015
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
October 25, 2016
Record last verified: 2016-10