High Risk Population of Part-time Seatbelt UsersNCT02258633
The Seatbelt Intervention Study
A study testing Interactive interview and tailored family centered seatbelt safety intervention in people with High Risk Population of Part-time Seatbelt Users, run by University of Michigan.
Trial summary
The study will use a randomized controlled design testing the effectiveness of the following intervention: (i) intervener brief intervention (IBI) vs. (ii) Enhanced usual care (EUC). The study will identify children ages 2-14 at a pediatric trauma center. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- High Risk Population of Part-time Seatbelt Users
- What is being tested?
- Interactive interview and tailored family centered seatbelt safety intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Feb 2010
- 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 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children ages 7-14 and their parent or guardian, at a pediatric trauma center
- Child admitted to hospital with diagnosis of injury other than sexual assault and suicide
- Identify as part time seat belt users
Who cannot join
- -
About this study
Official title: A Brief Tailored Family-centered Seatbelt Intervention for Hospitalized Trauma
The study will use a randomized controlled design testing the effectiveness of the following intervention: (i) intervener brief intervention (IBI) vs. (ii) Enhanced usual care (EUC). The study will identify children ages 2-14 at a pediatric trauma center. Children and their parents who agree to participate in the study will then complete a screening survey to identify part time seatbelt use. Those who screen positive will complete a more detailed baseline survey and then be randomized to one of two study conditions. At one month, a follow up assessment by telephone will be completed.
- Being tested
- Interactive interview and tailored family centered seatbelt safety intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive interview and tailored family centered seatbelt safety interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Intervener Brief Intervention (IBI) | Experimental | Subjects and parents will complete a Brief Motivational Interview (BMI) incorporating personalized feedback, discussion of choices and changes, and therapist led intervention message relating behavioral change and future goals. Receives: Other: Interactive interview and tailored family centered seatbelt safety intervention |
| Enhanced Usual Care | No intervention | Subjects and parents will receive standard trauma care, plus complete brief questionnaires and receive general safety information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seat belt use
Follow up telephone assessment on full time seat belt use by parent and child
Measured: 1 month
Seat belt knowledge
Follow up telephone assessment on level of knowledge of seat belt use and risk factors
Measured: 1 month
Attitudes
Follow up telephone assessment of positive attitude, motivation, and self-efficacy regarding safety restraint use.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startMar 2009
- Primary completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk Population of Part-time Seatbelt UsersStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Ehrlich, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258633
- Sponsor's protocol ID
- HUM00026025
- Status last verified
- Oct 2014
- First submitted
- 2 Oct 2014
- Last updated
- 7 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Tailored Family-centered Seatbelt Intervention for Hospitalized Trauma
- ClinicalTrials.gov ID
- NCT02258633
- Acronym / sponsor ID
- HUM00026025
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Feb 2010 (actual)
- First posted
- 7 Oct 2014 (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.
The study will use a randomized controlled design testing the effectiveness of the following intervention: (i) intervener brief intervention (IBI) vs. (ii) Enhanced usual care (EUC). The study will identify children ages 2-14 at a pediatric trauma center. Children and their parents who agree to participate in the study will then complete a screening survey to identify part time seatbelt use. Those who screen positive will complete a more detailed baseline survey and then be randomized to one of two study conditions. At one month, a follow up assessment by telephone will be completed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervener Brief Intervention (IBI) | Experimental | Other: Interactive interview and tailored family centered seatbelt safety interventionSubjects and parents will complete a Brief Motivational Interview (BMI) incorporating personalized feedback, discussion of choices and changes, and therapist led intervention message relating behavioral change and future goals. |
| Enhanced Usual Care | No intervention | –Subjects and parents will receive standard trauma care, plus complete brief questionnaires and receive general safety information. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children ages 7-14 and their parent or guardian, at a pediatric trauma center
- Child admitted to hospital with diagnosis of injury other than sexual assault and suicide
- Identify as part time seat belt users
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Interactive interview and tailored family centered seatbelt safety intervention | Other | Intervener Brief Intervention (IBI) |
Primary outcome
Seat belt use
Time frame: 1 month
Follow up telephone assessment on full time seat belt use by parent and child
Seat belt knowledge
Time frame: 1 month
Follow up telephone assessment on level of knowledge of seat belt use and risk factors
Attitudes
Time frame: 1 month
Follow up telephone assessment of positive attitude, motivation, and self-efficacy regarding safety restraint use.
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 7 Oct 2014.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive interview and tailored family centered seatbelt safety intervention in people with High Risk Population of Part-time Seatbelt Users, run by University of Michigan.
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 3 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 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Seat belt use (time frame: 1 month). The study lists 3 primary outcomes in all. 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 7 Oct 2014.