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| Name | Class |
|---|---|
| University of Michigan | OTHER |
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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.
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, CuÃdame 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Usual Care | No Intervention | Participants will be randomized after completion of the baseline survey and receive a basic information sheet (print or electronic). Months 1-12: Participants receive monthly, unscheduled requests to submit photographs as their child usually travels. Feedback is provided for critical errors and misuse. Follow-up occurs at 6 months. Outcomes are assessed at 12 months. | |
| Basic Intervention | Experimental | Participants will be randomized after completion of the baseline survey and receive a basic information sheet (print or electronic). Participants receive a counseling session, access to the study's tailored, educational website, and tailored informational and motivational text messages. Months 1-6: Participants receive monthly, unscheduled requests to submit photographs as their child usually travels. Feedback is provided. Follow-up occurs at 6 months. After completion of their 6 month follow-up, participants in the Basic Intervention group will be eligible for re-randomization if they continue to not adhere to guidelines or plan a premature transition. Months 7-12: Participants continue to receive monthly, unscheduled requests to submit photographs as their child usually travels. Feedback is provided. Outcomes are assessed at 12 months. |
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| Enhanced Intervention | Experimental | After completion of their 6 month follow-up, participants re-randomized to Enhanced Intervention receive Basic Intervention components plus an additional counseling session (Months 7/8) and additional tailored text messages (Months 7-12). Months 7-12: Participants continue to receive monthly, unscheduled requests to submit photographs as their child usually travels. Feedback is provided. Outcomes are assessed at 12 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiny Cargo, Big Deal/Abróchame Bien, CuÃdame Bien (TCBD/ABCB) Basic Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6-Month Assessment |
| 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 | 12-Month Assessment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12-Month Assessment |
| Child Passenger Safety Score (CPaSS) |
Child refers to the child of the caregiver (parent/legal guardian) who is being evaluated for recruitment and participation in the study.
Inclusion Criteria:
Exclusion Criteria:
Exclusions applied only to in-person recruitment in the ED:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Macy, MD | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41021229 | Derived | Macy ML, Pollock B, Kendi S, Goldstick J, Cieslak K, Carter PM, Resnicow K. Multimodal Intervention and Child Passenger Safety Guideline Adherence in Young Children: A Sequential, Multiple-Assignment, Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2533912. doi: 10.1001/jamanetworkopen.2025.33912. | |
| 35918028 | Derived |
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De-identified individual participant data that underlie the results, the study protocol, statistical analysis plan, and informed consent forms will be shared.
Beginning 9 months and ending 36 months following article publication.
Researchers who provide a methodologically sound proposal.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phases 1 and 2: Enhanced Usual Care | Participants were randomized in a 1:3 ratio (1 enhanced usual care : 3 basic intervention group) 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. Outcomes were assessed at 6 and 12 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1: Baseline Intervention |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2021 |
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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.
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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.
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| Tiny Cargo, Big Deal/Abróchame Bien, CuÃdame Bien (TCBD/ABCB) Enhanced Intervention | Behavioral | 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. |
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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. |
| 12-Month Assessment |
| Macy ML, Carter P, Kendi S, Pollock B, San Miguel L, Goldstick J, Resnicow K. "Tiny Cargo, Big Deal! Abrochame Bien, Cuidame Bien", an emergency department-based intervention to promote child passenger safety: Protocol for an adaptive randomized trial among caregivers of 6-month through 10-year-old children. Contemp Clin Trials. 2022 Sep;120:106863. doi: 10.1016/j.cct.2022.106863. Epub 2022 Jul 30. |
| FG001 | Phases 1 and 2: Basic Intervention | Tiny Cargo, Big Deal/Abróchame Bien, CuÃdame Bien (TCBD/ABCB) Basic Intervention is a bilingual precision prevention intervention grounded in Self-Determination Theory. The Basic TCBD/ABCB intervention integrates 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. Phase 1 Outcomes were assessed at 6 months. Participants who were guideline adherent at 6-months continued with basic mHealth. Re-randomization occurred at 6 month follow-up in a 1:1 ratio among participants who had not adopted guideline adherent behavior or still planned premature transition. Months 7-12: Participants who were guideline adherent at 6-months received four unscheduled requests to submit photographs as their child usually travels and were provided tailored feedback on restraint use. Phase 2 Outcomes were assessed at 12 months. |
| FG002 | Phase 2: Re-Randomized to Continue Basic Intervention (mHealth) | After completion of their 6 month follow-up, participants who were re-randomized to continue the Basic (mHealth) Intervention maintained access to the tailored, mobile-friendly, educational website and tailored educational and continued to receive motivational short message service (SMS) text message communications sent twice each month. In months 7-12, this group also received four unscheduled requests to submit photographs as their child usually travels and were provided tailored feedback on restraint use. Phase 2 Outcomes were assessed at 12 months. |
| FG003 | Phase 2: Re-Randomized to Enhanced Intervention (Booster MI Session) | After completion of 6 month follow-up, participants who were re-randomized to the Enhanced Intervention received an additional MI-based counseling session (in Months 7/8) and two additional tailored educational and motivational text messages per month (Months 7-12). Basic Intervention mHealth components for months 7-12 were continued, including photograph submission requests and feedback. Phase 2 Outcomes were assessed at 12 months. |
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| NOT COMPLETED |
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| Phase 2: Rerandomized at 6 Months |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Phase 1: Basic Intervention | Tiny Cargo, Big Deal/Abróchame Bien, CuÃdame 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Preferred Language | Count of Participants | Participants |
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| Relationship to Child | Count of Participants | Participants |
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| Highest Education Level Achieved | Count of Participants | Participants |
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| Children in Household | Count of Participants | Participants |
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| Child Age Category | Count of Participants | Participants |
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| Child Sex | Count of Participants | Participants |
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| Child Race and Ethnicity | Count of Participants | Participants |
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| Baseline Child Passenger Safety Behavior | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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 | Posted | Count of Participants | Participants | 6-Month Assessment |
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| 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 | Posted | Count of Participants | Participants | 12-Month Assessment |
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| 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. | Not Posted | Dec 2026 | 12-Month Assessment | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | Dec 2026 | 12-Month Assessment | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Posted | Count of Participants | Participants | 6-Month Assessment |
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| 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 | Posted | Count of Participants | Participants | 12-Month Assessment |
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Through study completion, an average of 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1: Enhanced Usual Care (EUC) | Participants randomized to EUC received a basic information sheet (print or electronic) at enrollment. EUC Months 1-6: Participants received four unscheduled requests, roughly monthly, to submit photographs as their child usually travels. Feedback was provided only if critical errors and misuse were observed. Outcomes were assessed at 6 months. | 0 | 118 | 0 | 118 | 2 | 118 |
| EG001 | Phase 1: Intervention | Tiny Cargo, Big Deal/Abróchame Bien, CuÃdame 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. | 0 | 274 | 0 | 274 | 7 | 274 |
| EG002 | Phase 2: Enhanced Usual Care (EUC) | EUC Months 7-12: Participants received four unscheduled requests, roughly monthly, to submit photographs as their child usually travels. Feedback was provided only if critical errors and misuse were observed. Outcomes were assessed at 12 months. | 0 | 111 | 0 | 111 | 1 | 111 |
| EG003 | Phase 2: Guideline Adherent at 6-month Follow-up | Months 7-12: Participants received four unscheduled requests to submit photographs as their child usually travels and were provided tailored feedback on restraint use. Outcomes were assessed at 12 months. | 0 | 77 | 0 | 77 | 3 | 77 |
| EG004 | Phase 2: Re-Randomized to Continue Basic Intervention (mHealth) | After completion of 6-month follow-up, Intervention Group participants who were re-randomized to continue the Basic Intervention received mHealth components including access to the tailored, mobile-friendly, educational website and tailored educational and motivational short message service (SMS) text message communications sent twice each month. In months 7-12, this group also received four unscheduled requests to submit photographs as their child usually travels and were provided tailored feedback on restraint use. Outcomes were assessed at 12 months. | 0 | 84 | 0 | 84 | 2 | 84 |
| EG005 | Phase 2: Re-Randomized to Enhanced Intervention (Booster MI Session) | After completion of 6-month follow-up, Intervention Group participants who were re-randomized to the Enhanced Intervention received an additional MI-based counseling session (in Months 7/8) and two additional tailored educational and motivational text messages per month. In months 7-12, this group received Basic Intervention mHealth components, including photograph submission requests and feedback. Outcomes were assessed at 12 months. | 0 | 87 | 0 | 87 | 4 | 87 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Possible Delayed Transition | General disorders | Non-systematic Assessment | Caregiver reported child's weight or height was above the maximum weight or height for a typical child passenger restraint system (CRS) within that mode (e.g., rear-facing), which could indicate the child was too heavy or tall for their usual CRS. |
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Recruitment was negatively impacted by the coronavirus disease 19 (COVID-19) pandemic and we were unable to achieve our target sample size. The Child Passenger Safety Score (CPaSS) Tool requires additional calibration to assure greater reliability before we are able to report outcomes that are dependent upon this score.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michelle Macy | Ann & Robert H. Lurie Children's Hospital of Chicago | 312-227-6676 | mmacy@luriechildrens.org |
| Nov 16, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 15, 2022 | Nov 16, 2024 | ICF_001.pdf |
| Lost to Follow-up |
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| 30-39 years |
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| 40-58 years |
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| Male |
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| Hispanic/Latine |
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| White, not Hispanic/Latine |
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| Other or multiple races, not Hispanic/Latine |
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| Spanish |
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| Father |
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| Grandparent |
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| Trade School or Associates Degree |
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| Bachelors Degree |
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| Graduate or Professional School |
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| 2 Children |
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| 3 Children |
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| 4 Children or more |
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| 3 years to <5 years |
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| 5 years through 10 years |
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| Female |
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| Hispanic/Latine |
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| White, not Hispanic/Latine |
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| Other or multiple races, not Hispanic/Latine |
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| Planning a premature transition to a less protective restraint in the next 6 months |
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| Superiority |
| OG002 | Phase 2: Re-Randomized to Continue Basic Intervention (mHealth) | After completion of 6-month follow-up, Intervention Group participants who were re-randomized to continue the Basic Intervention received mHealth components including access to the tailored, mobile-friendly, educational website and tailored educational and motivational short message service (SMS) text message communications sent twice each month. In months 7-12, this group also received four unscheduled requests to submit photographs as their child usually travels and were provided tailored feedback on restraint use. Outcomes were assessed at 12 months. |
| OG003 | Phase 2: Re-Randomized to Enhanced Intervention (Booster MI Session) | After completion of 6-month follow-up, Intervention Group participants who were re-randomized to the Enhanced Intervention received an additional MI-based counseling session (in Months 7/8) and two additional tailored educational and motivational text messages per month. In months 7-12, this group received Basic Intervention mHealth components, including photograph submission requests and feedback. Outcomes were assessed at 12 months. |
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| OG002 | Phase 2: Re-Randomized to Basic Intervention | After completion of 6-month follow-up, Intervention Group participants who were re-randomized to continue the Basic Intervention received mHealth components including access to the tailored, mobile-friendly, educational website and tailored educational and motivational short message service (SMS) text message communications sent twice each month. In months 7-12, this group also received four unscheduled requests to submit photographs as their child usually travels and were provided tailored feedback on restraint use. Outcomes were assessed at 12 months. |
| OG003 | Phase 2: Re-Randomized to Enhanced Intervention | After completion of 6-month follow-up, Intervention Group participants who were re-randomized to the Enhanced Intervention received an additional MI-based counseling session (in Months 7/8) and two additional tailored educational and motivational text messages per month. In months 7-12, this group received Basic Intervention mHealth components, including photograph submission requests and feedback. Outcomes were assessed at 12 months. |
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