Motor Vehicle InjuryBSTCPSNCT05490992
Behavioral Skills Training Methods to Reduce Car Seat Misuse
A study testing Behavioral Skills Training In-person in people with Motor Vehicle Injury, run by Pro Consumer Safety - Public Health Behavior Solutions at 1 site in United States.
Trial summary
The purpose of this study is to assess the effectiveness of child passenger educational methods to measure their ability to effectively reduce car seat misuse. The study will assess the traditional child passenger educational method delivered by a child passenger safety technician by comparing it to an in-person and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Motor Vehicle Injury
- What is being tested?
- Behavioral Skills Training In-person
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,448 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2015to 31 Dec 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women at least 7-month gestation and their partner, living within Los Angeles, Ventura, Orange, San Bernardino or Riverside counties; consented to the study and follow-up evaluation; and at the time of session had their child restraint system(s) and vehicle(s) available.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Pro Consumer Safety/Pro Car Seat Safety - NHTSA CPS Inspection Station
Los Angeles, California, 90005
About this study
Official title: In-person and Telehealth Versions of Behavioral Skills Training to Reduce Car Seat Misuse
The purpose of this study is to assess the effectiveness of child passenger educational methods to measure their ability to effectively reduce car seat misuse. The study will assess the traditional child passenger educational method delivered by a child passenger safety technician by comparing it to an in-person and virtual telehealth Behavioral Skills Training approach to reduce car seat misuse.
Read the detailed description
This study of 2,449 expectant couples involved two experiments. Experiment-1: included 1,224 participants, comparing 600 participants receiving no intervention and 600 participants receiving education with behavioral skills training (BST) in-person.
Experiment-2: included 1,224 participants, comparing 600 participants receiving BST-in-person to BST with telehealth.
- Conditions
- Motor Vehicle Injury
- Being tested
- Behavioral Skills Training In-person
- Keywords
- motor vehicle occupant injury, car seat misuse, car seat education, Behavioral Skills Training, Telehealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Skills Training In-personOther
Also called Behavioral Skills Training Telehealth
Both an in-person and virtual telehealth version of Behavioral Skills Training (BST) was compared to the "Car seat check-up traditional car seat educational method" and BST telehealth was compared to BST in-person.
| Study group | Role | What they receive |
|---|---|---|
| Car seat check-up traditional car seat educational method | No intervention | Experiment-1a: This included 600 expectant parents who were educated by a certified child passenger safety technician with a traditional car seat educational approach. All participants were assessed at baseline, no-intervention traditional education, and follow-up, between June 1, 2015 and May 30, 2016 |
| Behavioral Skills Training In-person Group A | Experimental | Experiment-1b: This included another 600 expectant parents who were educated by a certified child passenger safety technician an in-person Behavioral Skills Training (BST) approach. All participants were assessed at baseline, BST, and follow-up, between June 1, 2016 and May 30, 2017. Receives: Other: Behavioral Skills Training In-person |
| Behavioral Skills Training In-person Group B | Experimental | Experiment-2a: This included another 600 expectant parents who were educated by a certified child passenger safety technician an in-person Behavioral Skills Training (BST) approach. All participants were assessed at baseline, BST, and follow-up, between June 1, 2018 and June 30, 2019. Receives: Other: Behavioral Skills Training In-person |
| Behavioral Skills Training Telehealth | Experimental | Experiment-2b: This included another 600 expectant parents who were educated by a certified child passenger safety technician a virtual telehealth version of Behavioral Skills Training (BST). All participants were assessed at baseline, BST-Telehealth, and follow-up, between April 1, 2020 and December 31, 2021. Receives: Other: Behavioral Skills Training In-person |
What is being measured
The primary outcome is the main question the study is designed to answer.
child restraint misuse
Incidence of misuse
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Jun 2015
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Motor Vehicle InjuryStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is a quasi-experimental within-subjects group design. It consists of two experiments that included an equal number of participants.
- Masking
- None (open label)
- Enrolment
- 2,448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pro Consumer Safety - Public Health Behavior Solutions
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California
- Responsible party
- Principal investigator, James DeCarli, Pro Consumer Safety - Public Health Behavior Solutions
- Investigators
- James M DeCarli, PhD, MPH, Principal investigator, Public Health Behavior Solutions/State of California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490992
- Sponsor's protocol ID
- BSTCPS2022
- Acronym
- BSTCPS
- Status last verified
- Feb 2024
- First submitted
- 3 Aug 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boutain AR, Sheldon JB, Sherman JA. Evaluation of a telehealth parent training program in teaching self-care skills to children with autism. J Appl Behav Anal. 2020 Jul;53(3):1259-1275. doi: 10.1002/jaba.743. Epub 2020 Jul 13.
PubMed 32657441Carnett A, Hansen S, Tullis C, Machalicek W. Using behavioural skills training via telehealth to increase teachers use of communication interventions and increase student use of speech-generating devices in a high school functional skills classroom. J Intellect Disabil Res. 2021 Feb;65(2):133-148. doi: 10.1111/jir.12794. Epub 2020 Nov 13.
PubMed 33185000Dickson MJ, Vargo KK. Training kindergarten students lockdown drill procedures using behavioral skills training. J Appl Behav Anal. 2017 Apr;50(2):407-412. doi: 10.1002/jaba.369. Epub 2017 Jan 11.
PubMed 28078673Edgemon AK, Rapp JT, Brogan KM, Richling SM, Hamrick SA, Peters RJ, O'Rourke SA. Behavioral skills training to increase interview skills of adolescent males in a juvenile residential treatment facility. J Appl Behav Anal. 2020 Sep;53(4):2303-2318. doi: 10.1002/jaba.707. Epub 2020 Apr 17.
PubMed 32301517Executive Order. No. N-33-20 H.S.C. § 8567 8627 8665, 2020. https://covid19.ca.gov/img/Executive-Order-N-33-20.pdf
Giannakakos AR, Vladescu JC, Simon R. Teaching installation and use of child passenger safety restraints. J Appl Behav Anal. 2018 Oct;51(4):915-923. doi: 10.1002/jaba.493. Epub 2018 Jul 13.
PubMed 30006981Himle MB, Wright KA. Behavioral skills training to improve installation and use of child passenger safety restraints. J Appl Behav Anal. 2014 Fall;47(3):549-59. doi: 10.1002/jaba.143. Epub 2014 Jun 3.
PubMed 24891092Hoffman BD, Gallardo AR, Carlson KF. Unsafe from the Start: Serious Misuse of Car Safety Seats at Newborn Discharge. J Pediatr. 2016 Apr;171:48-54. doi: 10.1016/j.jpeds.2015.11.047. Epub 2015 Dec 18.
PubMed 26707620Miltenberger, Raymond G. "Behavioral Skills Training Procedures." (2016) Behavior Modification Principles and Procedures, 6th ed., Cenage Learning, pp. 223-242.
National Center for Statistics and Analysis. (2022, March - revised). Children: 2019 data. (Traffic Safety Facts. Report No. DOT HS 813 122). National Highway Traffic Safety Administration
National Highway Traffic Safety Administration. (2004, January). Misuse of Child Restraints (DOT HS 809 671). United States, Department of Transportation. https://www.nhtsa.gov/sites/nhtsa.gov/files/documents/809671.pdf
National Highway Traffic Safety Administration. (2022). The Right Seat. Parents Central-From Car Seats To Car Keys: Keeping Children Safe. Retrieved July 24, 2022, from https://one.nhtsa.gov/links/ParentsCentral/CarSeats.htm#.
Raymond, P. (2018, July). Additional Analysis of National Child Restraint Use Special Study: Child Restraint Misuse (DOT HS 812 527). Traffic Safety Facts: Research note. https://www.nhtsa.gov/sites/nhtsa.gov/files/documents/13648-additional_analysis_of_ncruss_071718_v3_tag.pdf
Rios, D., Schenk, Y. A., Eldridge, R. R., & Peterson, S. M. (2020). The Effects of Remote Behavioral Skills Training on Conducting Functional Analyses. Journal of Behavioral Education, 29(2), 449-468. https://doi.org/10.1007/s10864-020-09385-3.
Shigekawa E, Fix M, Corbett G, Roby DH, Coffman J. The Current State Of Telehealth Evidence: A Rapid Review. Health Aff (Millwood). 2018 Dec;37(12):1975-1982. doi: 10.1377/hlthaff.2018.05132.
PubMed 30633674
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-person and Telehealth Versions of Behavioral Skills Training to Reduce Car Seat Misuse
- ClinicalTrials.gov ID
- NCT05490992
- Acronym / sponsor ID
- BSTCPS / BSTCPS2022
- Conditions
- Motor Vehicle Injury
- Keywords
- motor vehicle occupant injury, car seat misuse, car seat education, Behavioral Skills Training, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,448 participants (actual)
- Lead sponsor
- Pro Consumer Safety - Public Health Behavior SolutionsUniversity, hospital or other
- Collaborators
- University of Southern California
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Aug 2022 (actual)
- 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 purpose of this study is to assess the effectiveness of child passenger educational methods to measure their ability to effectively reduce car seat misuse. The study will assess the traditional child passenger educational method delivered by a child passenger safety technician by comparing it to an in-person and virtual telehealth Behavioral Skills Training approach to reduce car seat misuse.
Detailed description
This study of 2,449 expectant couples involved two experiments. Experiment-1: included 1,224 participants, comparing 600 participants receiving no intervention and 600 participants receiving education with behavioral skills training (BST) in-person.
Experiment-2: included 1,224 participants, comparing 600 participants receiving BST-in-person to BST with telehealth.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study is a quasi-experimental within-subjects group design. It consists of two experiments that included an equal number of participants.
| Arm | Type | Receives |
|---|---|---|
| Car seat check-up traditional car seat educational method | No intervention | –Experiment-1a: This included 600 expectant parents who were educated by a certified child passenger safety technician with a traditional car seat educational approach. All participants were assessed at baseline, no-intervention traditional education, and follow-up, between June 1, 2015 and May 30, 2016 |
| Behavioral Skills Training In-person Group A | Experimental | Other: Behavioral Skills Training In-personExperiment-1b: This included another 600 expectant parents who were educated by a certified child passenger safety technician an in-person Behavioral Skills Training (BST) approach. All participants were assessed at baseline, BST, and follow-up, between June 1, 2016 and May 30, 2017. |
| Behavioral Skills Training In-person Group B | Experimental | Other: Behavioral Skills Training In-personExperiment-2a: This included another 600 expectant parents who were educated by a certified child passenger safety technician an in-person Behavioral Skills Training (BST) approach. All participants were assessed at baseline, BST, and follow-up, between June 1, 2018 and June 30, 2019. |
| Behavioral Skills Training Telehealth | Experimental | Other: Behavioral Skills Training In-personExperiment-2b: This included another 600 expectant parents who were educated by a certified child passenger safety technician a virtual telehealth version of Behavioral Skills Training (BST). All participants were assessed at baseline, BST-Telehealth, and follow-up, between April 1, 2020 and December 31, 2021. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women at least 7-month gestation and their partner, living within Los Angeles, Ventura, Orange, San Bernardino or Riverside counties; consented to the study and follow-up evaluation; and at the time of session had their child restraint system(s) and vehicle(s) available.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Behavioral Skills Training In-personAlso: Behavioral Skills Training TelehealthBoth an in-person and virtual telehealth version of Behavioral Skills Training (BST) was compared to the "Car seat check-up traditional car seat educational method" and BST telehealth was compared to BST in-person. | Other | Behavioral Skills Training In-person Group A, Behavioral Skills Training In-person Group B, Behavioral Skills Training Telehealth |
Primary outcome
child restraint misuse
Time frame: 12 months
Incidence of misuse
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 6 Feb 2024.
- Results publication: PubMed 32657441Boutain AR, Sheldon JB, Sherman JA. Evaluation of a telehealth parent training program in teaching self-care skills to children with autism. J Appl Behav Anal. 2020 Jul;53(3):1259-1275. doi: 10.1002/jaba.743. Epub 2020 Jul 13.
- Results publication: PubMed 33185000Carnett A, Hansen S, Tullis C, Machalicek W. Using behavioural skills training via telehealth to increase teachers use of communication interventions and increase student use of speech-generating devices in a high school functional skills classroom. J Intellect Disabil Res. 2021 Feb;65(2):133-148. doi: 10.1111/jir.12794. Epub 2020 Nov 13.
- Results publication: PubMed 28078673Dickson MJ, Vargo KK. Training kindergarten students lockdown drill procedures using behavioral skills training. J Appl Behav Anal. 2017 Apr;50(2):407-412. doi: 10.1002/jaba.369. Epub 2017 Jan 11.
- Results publication: PubMed 32301517Edgemon AK, Rapp JT, Brogan KM, Richling SM, Hamrick SA, Peters RJ, O'Rourke SA. Behavioral skills training to increase interview skills of adolescent males in a juvenile residential treatment facility. J Appl Behav Anal. 2020 Sep;53(4):2303-2318. doi: 10.1002/jaba.707. Epub 2020 Apr 17.
- Results publicationExecutive Order. No. N-33-20 H.S.C. § 8567 8627 8665, 2020. https://covid19.ca.gov/img/Executive-Order-N-33-20.pdf
- Results publication: PubMed 30006981Giannakakos AR, Vladescu JC, Simon R. Teaching installation and use of child passenger safety restraints. J Appl Behav Anal. 2018 Oct;51(4):915-923. doi: 10.1002/jaba.493. Epub 2018 Jul 13.
- Results publication: PubMed 24891092Himle MB, Wright KA. Behavioral skills training to improve installation and use of child passenger safety restraints. J Appl Behav Anal. 2014 Fall;47(3):549-59. doi: 10.1002/jaba.143. Epub 2014 Jun 3.
- Results publication: PubMed 26707620Hoffman BD, Gallardo AR, Carlson KF. Unsafe from the Start: Serious Misuse of Car Safety Seats at Newborn Discharge. J Pediatr. 2016 Apr;171:48-54. doi: 10.1016/j.jpeds.2015.11.047. Epub 2015 Dec 18.
- Results publicationMiltenberger, Raymond G. "Behavioral Skills Training Procedures." (2016) Behavior Modification Principles and Procedures, 6th ed., Cenage Learning, pp. 223-242.
- Results publicationNational Center for Statistics and Analysis. (2022, March - revised). Children: 2019 data. (Traffic Safety Facts. Report No. DOT HS 813 122). National Highway Traffic Safety Administration
- Results publicationNational Highway Traffic Safety Administration. (2004, January). Misuse of Child Restraints (DOT HS 809 671). United States, Department of Transportation. https://www.nhtsa.gov/sites/nhtsa.gov/files/documents/809671.pdf
- Results publicationNational Highway Traffic Safety Administration. (2022). The Right Seat. Parents Central-From Car Seats To Car Keys: Keeping Children Safe. Retrieved July 24, 2022, from https://one.nhtsa.gov/links/ParentsCentral/CarSeats.htm#.
- Individual participant dataSharing planned: No
Related trials for Motor Vehicle Injury
Recruiting
Recovering Sleep After Trauma
Post-traumatic Stress Disorder
Active, not recruitingPhase 4
Effectiveness of Contrast-Enhanced Ultrasound
Abdominal Injuries, Physical Abuse
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 M DeCarli, PhD, MPH principal investigator
Public Health Behavior Solutions/State of California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Skills Training In-person in people with Motor Vehicle Injury, run by Pro Consumer Safety - Public Health Behavior Solutions 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 1 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 6 Feb 2024. 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 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?
child restraint misuse (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05490992, which also lists 20 linked publications.
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 6 Feb 2024.