Accident, Traffic
Conditions
Keywords
child restraint systems (car seats and booster seats), seat belts, Motivational Interviewing
Brief summary
This study involves an emergency department (ED)-based intervention utilizing Motivational Interviewing (MI) techniques and patient-centered eHealth materials (e.g., a tailored, mobile-friendly website and text messages) 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 an adaptive randomized controlled trial, recruiting English and Spanish speaking caregivers of children 6 months to 10 years old.
Detailed description
Motor vehicle collisions (MVCs) remain the leading cause of unintentional injury deaths among children in the United States (U.S.) and racial/ethnic minority children are disproportionately impacted as suboptimal child passenger safety behaviors are more prevalent in some communities. Existing universal approaches to promote child passenger safety have fallen short of ensuring that all child passengers are correctly using size-appropriate child passenger restraints according to guidelines published by the American Academy of Pediatrics and the National Highway Traffic Safety Administration. Precision prevention programs are urgently needed to improve child passenger safety behaviors among caregivers who have not been responsive to guidelines, laws, and public education campaigns. The proposed research will test the efficacy of Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB), a bilingual emergency department (ED)-based precision prevention intervention grounded in Self-Determination Theory. TCBD/ABCB integrates personalized counseling based on principles of motivational interviewing (MI) and eHealth components including a tailored educational mobile-friendly website "site" and short message service (SMS) communications with the goal of improving child passenger safety. We hypothesize that by providing tailored child passenger safety education and personalized skills for restraint use in a manner that supports autonomous motivation the TCBD/ABCB intervention will be more efficacious than universal approaches (laws/guidelines) for realizing correct use of size-appropriate child passenger restraints.
Interventions
BEHAVIORALTiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention
A bilingual emergency department (ED)-based precision prevention intervention grounded in Self-Determination Theory. The Basic TCBD/ABCB intervention integrates one personalized counseling session based on principles of motivational interviewing (MI) and eHealth components including a tailored mobile-friendly educational website and short message service (SMS) text message communications with the goal of improving child passenger safety. Participants receive monthly text message requests to submit photographs depicting the child as they usually travel. Feedback is provided via text message to correct any observed errors or misuse. Tailored informational and motivational text messages are sent twice each month.
BEHAVIORALTiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Enhanced Intervention
The Enhanced TCBD/ABCB Intervention includes a second motivational interviewing session. Basic Intervention text messages continue with an additional 1-2 tailored text messages per month.
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
This is a single-blinded study where a portion of the study will include blinding of study team members who are assessing outcomes. The blinding will not include the participants. The portion of the study that includes blinding is the review of the monthly photo submissions. Participants send us via text message over the course of 12 months. Each photograph is reviewed and scored by two team members. The first reviewer is blinded to study condition and saves the photographs with the child's face blurred. The second reviewer scores the photographs after the child's face has been blurred to verify findings of the first reviewer. The second reviewer is then unblinded to send feedback to the caregiver appropriate for their study condition.
Intervention model description
After the baseline survey, all participants will be randomized into one of two groups: 1) basic intervention or 2) control group. Block randomization (block sizes from four to eight) will be applied to assign participants to intervention or control in a 3:1 ratio. Blocks will be stratified by child passenger safety recommendations for age (\<2 years, rear-facing; 2-4 years, forward-facing; 5+ years, booster seat) and reason for study eligibility (not consistently using the recommended restraint for age and size or planning a premature transition in the coming 6 months). After 6-month follow-up, participants in the intervention group only who continue suboptimal child passenger safety behaviors will be re-randomized in a 1:1 ratio to basic or enhanced intervention.
Eligibility
Sex/Gender
ALL
Age
6 Months to 10 Years
Healthy volunteers
No
Inclusion criteria
Child refers to the child of the caregiver (parent/legal guardian) who is being evaluated for recruitment and participation in the study. Inclusion Criteria: * Child is age 6 months to 10 years old at screening * Child is seeking care in the Emergency Department (ED) for a non-critical injury or illness * Child sought emergency or urgent care at a study site * Caregiver/parent is the legal guardian of the child who is receiving or received emergency or urgent care at a study site * Child is less than 55 inches tall * Caregiver speaks English or Spanish * Caregiver is 18 years old or older * Caregiver screening survey responses indicate: child travels at least once per week in a passenger vehicle * AND child is able to use a standard car seat or booster seat (child restraint system) but is not using an age and size-appropriate child restraint system OR travels unrestrained OR sits in the vehicle front seat OR caregiver plans to stop using the age and size-appropriate restraint in the next 6 months (planned premature transition)
Exclusion criteria
* Caregiver does not understand/speak English or Spanish * Child is seeking/sought care for child abuse/neglect * Child is seeking/sought care that requires intensive psychosocial services * Child is seeking/sought treatment for a motor vehicle related injury * Child is too tall for study (height = \>55 inches tall) * Caregiver is under 18 years of age * Caregiver does not have a smart phone * Caregiver lives outside of the state of Illinois * Caregiver is already enrolled in this study * Caregiver completed the screen to determine eligibility for study in the past 6 months Exclusions applied only to in-person recruitment in the ED: * Child is seeking treatment for a new long-term diagnosis * Child has anticipated need for admission * Child is seeking care for a critical illness or injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 6 Months | 6-Month Assessment | At the 6-month follow-up assessment, conducted remotely, we reassessed the child's restraint system use and safety behaviors. For this dichotomous outcome, caregivers were considered guideline adherent if: 1) the caregiver-reported usual restraint was age and size APPROPRIATE;\* and 2) the child was reported to NEVER travel UNRESTRAINED; and 3) ALWAYS seated in the vehicle BACK SEAT. \*weight, height, and age parameters: Rear-facing appropriate if child \<40 pounds; \<40 inches; up to age 3 Forward-facing appropriate if child \>=22 pounds, \<65 pounds; \>=28 inches, \<49 inches, at least 3 years old Booster appropriate if child \>=40 pounds, \<100 pounds; High Back \>=38 inches/Backless \>=43 inches; \<57 inches, at least 5 years old Seat Belt alone appropriate if child \>=100 pounds; at least 57 inches |
| Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 12 Months | 12-Month Assessment | At the 12-month follow-up assessment, conducted remotely, we reassessed the child's restraint system use. For this dichotomous outcome, caregivers were considered guideline adherent if: 1) the caregiver-reported usual restraint was age and size APPROPRIATE;\* and 2) the child was reported to NEVER travel UNRESTRAINED; and 3) ALWAYS seated in the vehicle BACK SEAT. \*weight, height, and age parameters: Rear-facing appropriate if child \<40 pounds; \<40 inches; up to age 3 Forward-facing appropriate if child \>=22 pounds, \<65 pounds; \>=28 inches, \<49 inches, at least 3 years old Booster appropriate if child \>=40 pounds, \<100 pounds; High Back \>=38 inches/Backless \>=43 inches; \<57 inches, at least 5 years old Seat Belt alone appropriate if child \>=100 pounds; at least 57 inches |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichelle Macy, MD
Ann & Robert H Lurie Children's Hospital of Chicago
Participant flow
Recruitment details
Recruitment conducted in person, 2/5/2020-3/9/2020, in a single children's hospital emergency department followed by remote recruitment, 6/29/2020-9/19/2022, in the children's hospital emergency department, two children's hospital urgent care locations, and an affiliated community hospital emergency department in metropolitan Chicago.
Pre-assignment details
31 caregivers were enrolled in the study and did not complete the baseline survey. Randomization occurred after completion of the baseline survey and therefore this group was not randomized. These caregivers did not participate in study activities after informed consent. 8 caregivers were determined to be ineligible after baseline survey and randomization.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1: Enhanced Usual Care Participants were randomized after completion of the baseline survey and received a basic information sheet (print or electronic).
Months 1-12: Participants received eight unscheduled requests, roughly monthly, to submit photographs as their child usually travels. Feedback was provided only if critical errors and misuse were observed. Phase 1 Outcomes were assessed at 6 months. | 132 |
| Phase 1: Basic Intervention Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention is a bilingual precision prevention intervention grounded in Self-Determination Theory. The TCBD/ABCB intervention integrated one remote, personalized counseling session based on principles of motivational interviewing (MI) and mHealth components including a tailored, mobile-friendly, educational website and tailored educational and motivational short message service (SMS) text message communications sent twice each month.
Months 1-6: Participants received four unscheduled requests to submit photographs as their child usually travels and were provided tailored feedback restraint use.
Outcomes were assessed at 6 months. Re-randomization occurred at 6-month follow-up among participants who had not adopted guideline adherent behavior or still planned premature transition. | 342 |
| Total | 474 |
Baseline characteristics
| Characteristic | Phase 1: Enhanced Usual Care | Total | Phase 1: Basic Intervention |
|---|---|---|---|
| Age, Continuous | 36 years | 36 years | 36.5 years |
| Age, Customized 20-29 years | 21 Participants | 75 Participants | 54 Participants |
| Age, Customized 30-39 years | 76 Participants | 264 Participants | 188 Participants |
| Age, Customized 40-58 years | 35 Participants | 135 Participants | 100 Participants |
| Baseline Child Passenger Safety Behavior Not using recommended child passenger restraint or rides in front seat | 94 Participants | 341 Participants | 247 Participants |
| Baseline Child Passenger Safety Behavior Planning a premature transition to a less protective restraint in the next 6 months | 38 Participants | 133 Participants | 95 Participants |
| Child Age Category 3 years to <5 years | 25 Participants | 97 Participants | 72 Participants |
| Child Age Category 5 years through 10 years | 49 Participants | 179 Participants | 130 Participants |
| Child Age Category 6 months to <3 years | 58 Participants | 198 Participants | 140 Participants |
| Child Race and Ethnicity Black, not Hispanic/Latine | 11 Participants | 61 Participants | 50 Participants |
| Child Race and Ethnicity Hispanic/Latine | 60 Participants | 201 Participants | 141 Participants |
| Child Race and Ethnicity Other or multiple races, not Hispanic/Latine | 24 Participants | 58 Participants | 34 Participants |
| Child Race and Ethnicity White, not Hispanic/Latine | 37 Participants | 154 Participants | 117 Participants |
| Children in Household 1 Child (Study Child) | 36 Participants | 132 Participants | 96 Participants |
| Children in Household 2 Children | 50 Participants | 182 Participants | 132 Participants |
| Children in Household 3 Children | 33 Participants | 119 Participants | 86 Participants |
| Children in Household 4 Children or more | 13 Participants | 41 Participants | 28 Participants |
| Child Sex Female | 54 Participants | 194 Participants | 140 Participants |
| Child Sex Male | 78 Participants | 280 Participants | 202 Participants |
| Highest Education Level Achieved Bachelors Degree | 43 Participants | 128 Participants | 85 Participants |
| Highest Education Level Achieved Graduate or Professional School | 36 Participants | 161 Participants | 125 Participants |
| Highest Education Level Achieved High School or less | 33 Participants | 109 Participants | 76 Participants |
| Highest Education Level Achieved Trade School or Associates Degree | 20 Participants | 76 Participants | 56 Participants |
| Preferred Language English | 119 Participants | 422 Participants | 303 Participants |
| Preferred Language Spanish | 13 Participants | 52 Participants | 39 Participants |
| Race/Ethnicity, Customized Black, not Hispanic/Latine | 12 Participants | 65 Participants | 53 Participants |
| Race/Ethnicity, Customized Hispanic/Latine | 60 Participants | 188 Participants | 128 Participants |
| Race/Ethnicity, Customized Other or multiple races, not Hispanic/Latine | 19 Participants | 44 Participants | 25 Participants |
| Race/Ethnicity, Customized White, not Hispanic/Latine | 41 Participants | 177 Participants | 136 Participants |
| Region of Enrollment United States | 132 participants | 474 participants | 342 participants |
| Relationship to Child Father | 10 Participants | 30 Participants | 20 Participants |
| Relationship to Child Grandparent | 1 Participants | 1 Participants | 0 Participants |
| Relationship to Child Mother | 121 Participants | 443 Participants | 322 Participants |
| Sex: Female, Male Female | 121 Participants | 442 Participants | 321 Participants |
| Sex: Female, Male Male | 11 Participants | 32 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 118 | 0 / 274 | 0 / 111 | 0 / 77 | 0 / 84 | 0 / 87 |
| other Total, other adverse events | 2 / 118 | 7 / 274 | 1 / 111 | 3 / 77 | 2 / 84 | 4 / 87 |
| serious Total, serious adverse events | 0 / 118 | 0 / 274 | 0 / 111 | 0 / 77 | 0 / 84 | 0 / 87 |
Outcome results
Primary
Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 12 Months
At the 12-month follow-up assessment, conducted remotely, we reassessed the child's restraint system use. For this dichotomous outcome, caregivers were considered guideline adherent if: 1) the caregiver-reported usual restraint was age and size APPROPRIATE;\* and 2) the child was reported to NEVER travel UNRESTRAINED; and 3) ALWAYS seated in the vehicle BACK SEAT. \*weight, height, and age parameters: Rear-facing appropriate if child \<40 pounds; \<40 inches; up to age 3 Forward-facing appropriate if child \>=22 pounds, \<65 pounds; \>=28 inches, \<49 inches, at least 3 years old Booster appropriate if child \>=40 pounds, \<100 pounds; High Back \>=38 inches/Backless \>=43 inches; \<57 inches, at least 5 years old Seat Belt alone appropriate if child \>=100 pounds; at least 57 inches
Time frame: 12-Month Assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1: Enhanced Usual Care | Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 12 Months | 43 Participants |
| Phase 1: Basic Intervention | Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 12 Months | 59 Participants |
| Phase 2: Re-Randomized to Continue Basic Intervention (mHealth) | Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 12 Months | 40 Participants |
| Phase 2: Re-Randomized to Enhanced Intervention (Booster MI Session) | Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 12 Months | 39 Participants |
Comparison: This analysis is limited to the Phase 2 participants who were re-randomized at 6 months to test the hypothesis that the enhanced intervention (with booster MI session) would have greater guideline adherent child passenger safety behaviors at 12 month follow-up than the group that continued in the basic intervention (mHealth components).p-value: 0.67195% CI: [0.4535589, 1.663695]Regression, Logistic
p-value: <0.00195% CI: [3.173121, 14.82896]Regression, Logistic
Primary
Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 6 Months
At the 6-month follow-up assessment, conducted remotely, we reassessed the child's restraint system use and safety behaviors. For this dichotomous outcome, caregivers were considered guideline adherent if: 1) the caregiver-reported usual restraint was age and size APPROPRIATE;\* and 2) the child was reported to NEVER travel UNRESTRAINED; and 3) ALWAYS seated in the vehicle BACK SEAT. \*weight, height, and age parameters: Rear-facing appropriate if child \<40 pounds; \<40 inches; up to age 3 Forward-facing appropriate if child \>=22 pounds, \<65 pounds; \>=28 inches, \<49 inches, at least 3 years old Booster appropriate if child \>=40 pounds, \<100 pounds; High Back \>=38 inches/Backless \>=43 inches; \<57 inches, at least 5 years old Seat Belt alone appropriate if child \>=100 pounds; at least 57 inches
Time frame: 6-Month Assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1: Enhanced Usual Care | Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 6 Months | 38 Participants |
| Phase 1: Basic Intervention | Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 6 Months | 131 Participants |
Comparison: We hypothesized the intervention group would have greater child passenger safety guideline adherence at 6 months compared with enhanced usual care group. In planning the trial, we assumed 75% of TCBD caregivers would be re-randomized. Baseline randomization was stratified by recommended CRS (rear-facing seat, forward-facing seat, booster seat) and reason for eligibility (not using the recommended CRS at baseline or planning a premature transition in the next 6 months).p-value: 0.00695% CI: [1.193531, 2.949084]Regression, Logistic
Other Pre-specified
Child Passenger Safety Score (CPaSS)
At the 12-month follow-up assessment, we obtained photographs from the caregiver remotely or by research staff in-person. Photographs will be reviewed using the Child Passenger Safety Score checklist. Points will be deducted from a perfect score of 100 based on observe errors and misuse.
Time frame: 12-Month Assessment
Other Pre-specified
CPaSS Trajectories
We will use latent growth curve models to identify characteristic trajectories for Child Passenger Safety Scores based on photographs of children as they typically travel obtained at baseline, months 1-4, 6-month assessment, months 8-11, and 12-month assessment.
Time frame: 12-Month Assessment
Post Hoc
Number of Participants With Age- and Size-Appropriate Child Passenger Restraint System Use at 12 Months
At the 12-month follow-up assessment, conducted remotely, we reassessed the child's restraint system use and safety behaviors. For this dichotomous outcome, caregivers were considered guideline adherent if the caregiver-reported usual restraint was appropriate for the child's weight, height, and age.\* \*weight, height, and age parameters: Rear-facing appropriate if child \<40 pounds; \<40 inches; up to age 3 Forward-facing appropriate if child \>=22 pounds, \<65 pounds; \>=28 inches, \<49 inches, at least 3 years old Booster appropriate if child \>=40 pounds, \<100 pounds; High Back \>=38 inches/Backless \>=43 inches; \<57 inches, at least 5 years old Seat Belt alone appropriate if child \>=100 pounds; at least 57 inches
Time frame: 12-Month Assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1: Enhanced Usual Care | Number of Participants With Age- and Size-Appropriate Child Passenger Restraint System Use at 12 Months | 59 Participants |
| Phase 1: Basic Intervention | Number of Participants With Age- and Size-Appropriate Child Passenger Restraint System Use at 12 Months | 65 Participants |
| Phase 2: Re-Randomized to Continue Basic Intervention (mHealth) | Number of Participants With Age- and Size-Appropriate Child Passenger Restraint System Use at 12 Months | 46 Participants |
| Phase 2: Re-Randomized to Enhanced Intervention (Booster MI Session) | Number of Participants With Age- and Size-Appropriate Child Passenger Restraint System Use at 12 Months | 49 Participants |
p-value: 0.75295% CI: [0.5735782, 2.159233]Regression, Logistic
p-value: <0.00195% CI: [3.321933, 19.07362]Regression, Logistic
Post Hoc
Number of Participants With Age- and Size-Appropriate Child Passenger Restraint System Use at 6 Months
At the 6-month follow-up assessment, conducted remotely, we reassessed the child's restraint system use. For this dichotomous outcome, caregivers were considered guideline adherent if the caregiver-reported usual restraint was appropriate for the child's weight, height, and age.\* \*weight, height, and age parameters: Rear-facing appropriate if child \<40 pounds; \<40 inches; up to age 3 Forward-facing appropriate if child \>=22 pounds, \<65 pounds; \>=28 inches, \<49 inches, at least 3 years old Booster appropriate if child \>=40 pounds, \<100 pounds; High Back \>=38 inches/Backless \>=43 inches; \<57 inches, at least 5 years old Seat Belt alone appropriate if child \>=100 pounds; at least 57 inches
Time frame: 6-Month Assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1: Enhanced Usual Care | Number of Participants With Age- and Size-Appropriate Child Passenger Restraint System Use at 6 Months | 52 Participants |
| Phase 1: Basic Intervention | Number of Participants With Age- and Size-Appropriate Child Passenger Restraint System Use at 6 Months | 156 Participants |
p-value: 0.03295% CI: [1.049169, 2.886676]Regression, Logistic