Car SeatsNCT00476255
Evaluating Models for Dissemination of Injury Prevention Information in the Pediatric Emergency Department Setting
A study testing Brief Motivational Intervention (BMI) in people with Car Seats and Injuries, run by Rhode Island Hospital at 1 site in United States.
Trial summary
This study examines the Pediatric Emergency Department as a location for increasing safe car seat practices by parents who are not restraining their children appropriately in motor vehicles. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Brief Motivational Intervention (BMI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Nov 2014
- 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
- Parents/primary caregivers of children ages 0-7 years who are being seen in the Pediatric ED for a non life-threatening injury or non-injury related complaint
- Parents/primary caregivers whose children are medically stable
- Parent/primary caregiver has legal custody of the index child and is able to provide informed consent for participation
- Parent/primary caregiver speaks English or Spanish
- Parent/primary caregiver must have access to a motor vehicle in which the child is transported
Who cannot join
- parents/primary caregivers who are cognitively unable to take part in the intervention
- those whose children are suspected by the clinical staff of being victims of child abuse
- those whose children are medically or surgically unstable
- those whose children are being evaluated for possible psychiatric disorders or suicidal ideation
- those who do not speak English or Spanish, and those without a telephone
Trial locations and contacts
1 site in 1 country.
United States1 site
Hasbro Children's Hospital
Providence, Rhode Island, 02903
About this study
Official title: Evaluating Models for Dissemination of Injury Prevention Information in the PED
This study examines the Pediatric Emergency Department as a location for increasing safe car seat practices by parents who are not restraining their children appropriately in motor vehicles. Three different intervention will be tested to determine their effectiveness in increasing safe car seat practices: usual emergency department care; provision of printed materials; and a brief motivational intervention in the emergency department.
Read the detailed description
The long-term goal of the present research program is to enhance the utilization of evidence-based injury prevention strategies and to encourage medical practitioners to disseminate focused information regarding injury prevention in the Pediatric Emergency Department (ED). This study examines the Pediatric Emergency Department as a location for increasing safe car seat practices by parents who are not restraining their children appropriately in motor vehicles. Three different intervention will be tested to determine their effectiveness in increasing safe car seat practices. The proposed research plan: 1. examines the efficacy of a Brief Motivational Intervention to enhance automobile safety restraint-specific injury prevention behaviors in parents/caregivers of younger children; and 2. examines the efficacy of focused, behavior-specific, injury prevention discharge instruction supplements (Enhanced Standard Care) in increasing safety restraint-specific injury prevention behaviors in parents/caregivers of younger children. We will conduct a randomized, controlled trial of parent/caregivers of children being evaluated in the Hasbro Children's Hospital Emergency Department in Providence, Rhode Island. Eligible, consenting participants will be screened with an injury assessment tool for inappropriate use of motor vehicle child safety restraints. High risk participants will be randomized into three intervention groups: Standard Care (SC), Enhanced Standard Care (ESC) and Brief Motivational Intervention (BMI). All participants will then be contacted three months following enrollment and surveyed regarding child safety restraint practices, attitudes and knowledge. The following main effects will be evaluated with relation to child safety restraint practice and attitude change: 1. Intervention (SC vs. ESC vs. BMI); 2. Injury status of child (Injured vs. non-injured). In addition, we will monitor re-injury rates of the index children of all enrolled parent/caregivers for one year from the time of enrollment and compare on the bases of the above main effects.
- Being tested
- Enhanced Standard Care (ESC), Brief Motivational Intervention (BMI)
- Keywords
- child safety restraint, injury prevention, automotive
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Standard Care (ESC)Behavioural
Reading material
Brief Motivational Intervention (BMI)Behavioural
Motivational interview with trained therapist
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Standard Care | Active comparator | Instructional materials Receives: Behavioral: Enhanced Standard Care (ESC) |
| Motivational Intervention | Experimental | Motivational interview Receives: Behavioral: Brief Motivational Intervention (BMI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported child safety restraint practices, attitudes and knowledge
Measured: 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startDec 2011
- Primary completionNov 2014
Why it stopped: Unfunded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Car SeatsStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Investigators
- James G Linakis, PhD, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476255
- Sponsor's protocol ID
- 0080-06
- Status last verified
- Apr 2010
- First submitted
- 18 May 2007
- Last updated
- 7 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Models for Dissemination of Injury Prevention Information in the PED
- ClinicalTrials.gov ID
- NCT00476255
- Acronym / sponsor ID
- 0080-06
- Keywords
- child safety restraint, injury prevention, automotive
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unfunded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Nov 2014 (actual)
- First posted
- 21 May 2007 (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 examines the Pediatric Emergency Department as a location for increasing safe car seat practices by parents who are not restraining their children appropriately in motor vehicles. Three different intervention will be tested to determine their effectiveness in increasing safe car seat practices: usual emergency department care; provision of printed materials; and a brief motivational intervention in the emergency department.
Detailed description
The long-term goal of the present research program is to enhance the utilization of evidence-based injury prevention strategies and to encourage medical practitioners to disseminate focused information regarding injury prevention in the Pediatric Emergency Department (ED). This study examines the Pediatric Emergency Department as a location for increasing safe car seat practices by parents who are not restraining their children appropriately in motor vehicles. Three different intervention will be tested to determine their effectiveness in increasing safe car seat practices. The proposed research plan: 1. examines the efficacy of a Brief Motivational Intervention to enhance automobile safety restraint-specific injury prevention behaviors in parents/caregivers of younger children; and 2. examines the efficacy of focused, behavior-specific, injury prevention discharge instruction supplements (Enhanced Standard Care) in increasing safety restraint-specific injury prevention behaviors in parents/caregivers of younger children. We will conduct a randomized, controlled trial of parent/caregivers of children being evaluated in the Hasbro Children's Hospital Emergency Department in Providence, Rhode Island. Eligible, consenting participants will be screened with an injury assessment tool for inappropriate use of motor vehicle child safety restraints. High risk participants will be randomized into three intervention groups: Standard Care (SC), Enhanced Standard Care (ESC) and Brief Motivational Intervention (BMI). All participants will then be contacted three months following enrollment and surveyed regarding child safety restraint practices, attitudes and knowledge. The following main effects will be evaluated with relation to child safety restraint practice and attitude change: 1. Intervention (SC vs. ESC vs. BMI); 2. Injury status of child (Injured vs. non-injured). In addition, we will monitor re-injury rates of the index children of all enrolled parent/caregivers for one year from the time of enrollment and compare on the bases of the above main effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Standard Care | Active comparator | Behavioral: Enhanced Standard Care (ESC)Instructional materials |
| Motivational Intervention | Experimental | Behavioral: Brief Motivational Intervention (BMI)Motivational interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Parents/primary caregivers of children ages 0-7 years who are being seen in the Pediatric ED for a non life-threatening injury or non-injury related complaint
- Parents/primary caregivers whose children are medically stable
- Parent/primary caregiver has legal custody of the index child and is able to provide informed consent for participation
- Parent/primary caregiver speaks English or Spanish
- Parent/primary caregiver must have access to a motor vehicle in which the child is transported
Key exclusion criteria (5 listed)
- parents/primary caregivers who are cognitively unable to take part in the intervention
- those whose children are suspected by the clinical staff of being victims of child abuse
- those whose children are medically or surgically unstable
- those whose children are being evaluated for possible psychiatric disorders or suicidal ideation
- those who do not speak English or Spanish, and those without a telephone
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 |
|---|---|---|
| Enhanced Standard Care (ESC)Reading material | Behavioural | Enhanced Standard Care |
| Brief Motivational Intervention (BMI)Motivational interview with trained therapist | Behavioural | Motivational Intervention |
Primary outcome
Self-reported child safety restraint practices, attitudes and knowledge
Time frame: 3 months post intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 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.
James G Linakis, PhD, MD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Motivational Intervention (BMI) in people with Car Seats and Injuries, run by Rhode Island Hospital at 1 site 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 7 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Self-reported child safety restraint practices, attitudes and knowledge (time frame: 3 months post intervention). 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 Nov 2014.