Child Restraint SystemsNCT02496481
A Brief MI Intervention in the ED to Increase Child Passenger Restraint Use
A study testing Motivational Interviewing and Tailored brochure in people with Child Restraint Systems and Seat Belts, run by University of Michigan at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Restraint Systems, Seat Belts
- What is being tested?
- Motivational Interviewing and Tailored brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Adult participants must be able to speak and read English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan C.S. Mott Children's Hospital Emergency Department
Ann Arbor, Michigan, 48109
Hurley Medical Center Emergency Department
Flint, Michigan, 48503
About this study
Official title: A Brief Motivational Interviewing Intervention in the Emergency Department to Increase Size-Appropriate 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.
Read the 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
- Being tested
- Motivational Interviewing, Tailored brochure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
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 brochureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group1 Baseline+MI+tailored brochure | Experimental | 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. Receives: Behavioral: Motivational Interviewing; Behavioral: Tailored brochure |
| Group2 Baseline+MI+general info | Experimental | 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. Receives: Behavioral: Motivational Interviewing |
| Group3 Baseline+tailored brochure | Experimental | 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. Receives: Behavioral: Tailored brochure |
| Group4 Baseline+general info | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month follow up
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Restraint SystemsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Hurley Medical Center
- Responsible party
- Principal investigator, Michelle L. Macy, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496481
- Sponsor's protocol ID
- HUM00096047
- Status last verified
- Oct 2016
- First submitted
- 6 Jul 2015
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Motivational Interviewing Intervention in the Emergency Department to Increase Size-Appropriate Child Passenger Restraint Use
- ClinicalTrials.gov ID
- NCT02496481
- Acronym / sponsor ID
- HUM00096047
- Conditions
- Child Restraint Systems, Seat Belts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Hurley Medical Center
- Study start
- Jun 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group1 Baseline+MI+tailored brochure | Experimental | Behavioral: Motivational Interviewing, Behavioral: Tailored brochureParticipants 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 | Experimental | Behavioral: Motivational InterviewingParticipants 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 | Experimental | Behavioral: Tailored brochureParticipants 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 intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Adult participants must be able to speak and read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingMotivational 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. | Behavioural | Group1 Baseline+MI+tailored brochure, Group2 Baseline+MI+general info |
| Tailored brochureTailored 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. | Behavioural | Group1 Baseline+MI+tailored brochure, Group3 Baseline+tailored brochure |
Primary outcome
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.
4 secondary outcomes
Transition at the recommended time
Time frame: 6 month follow up
Change in sub-optimal restraint use
Time frame: 6 month follow up
Acceptability of the intervention (composite measure)
Time frame: 2 week follow up
Acceptability of the intervention (composite measure)
Time frame: 6 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Tailored brochure in people with Child Restraint Systems and Seat Belts, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of size-appropriate restraint (time frame: 6 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.