Trial Outcomes & Findings for Tiny Cargo, Big Deal! An ED-Based Study of Child Passenger Safety Behaviors (NCT NCT04238247)
NCT ID: NCT04238247
Last Updated: 2025-05-23
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
513 participants
Primary outcome timeframe
6-Month Assessment
Results posted on
2025-05-23
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
Phases 1 and 2: 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 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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Phase 1: Baseline Intervention
STARTED
|
132
|
342
|
0
|
0
|
|
Phase 1: Baseline Intervention
COMPLETED
|
118
|
274
|
0
|
0
|
|
Phase 1: Baseline Intervention
NOT COMPLETED
|
14
|
68
|
0
|
0
|
|
Phase 2: Rerandomized at 6 Months
STARTED
|
118
|
89
|
92
|
93
|
|
Phase 2: Rerandomized at 6 Months
COMPLETED
|
111
|
77
|
84
|
87
|
|
Phase 2: Rerandomized at 6 Months
NOT COMPLETED
|
7
|
12
|
8
|
6
|
Reasons for withdrawal
| Measure |
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.
|
Phases 1 and 2: 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 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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Phase 1: Baseline Intervention
Withdrawal by Subject
|
3
|
19
|
0
|
0
|
|
Phase 1: Baseline Intervention
Lost to Follow-up
|
11
|
49
|
0
|
0
|
|
Phase 2: Rerandomized at 6 Months
Withdrawal by Subject
|
0
|
1
|
0
|
2
|
|
Phase 2: Rerandomized at 6 Months
Lost to Follow-up
|
7
|
11
|
8
|
4
|
Baseline Characteristics
Tiny Cargo, Big Deal! An ED-Based Study of Child Passenger Safety Behaviors
Baseline characteristics by cohort
| Measure |
Phase 1: Enhanced Usual Care
n=132 Participants
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.
|
Phase 1: Basic Intervention
n=342 Participants
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.
|
Total
n=474 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
n=5 Participants
|
36.5 years
n=7 Participants
|
36 years
n=5 Participants
|
|
Age, Customized
20-29 years
|
21 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
76 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
|
Age, Customized
40-58 years
|
35 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
121 Participants
n=5 Participants
|
321 Participants
n=7 Participants
|
442 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, not Hispanic/Latine
|
12 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latine
|
60 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, not Hispanic/Latine
|
41 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other or multiple races, not Hispanic/Latine
|
19 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
132 participants
n=5 Participants
|
342 participants
n=7 Participants
|
474 participants
n=5 Participants
|
|
Preferred Language
English
|
119 Participants
n=5 Participants
|
303 Participants
n=7 Participants
|
422 Participants
n=5 Participants
|
|
Preferred Language
Spanish
|
13 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Relationship to Child
Mother
|
121 Participants
n=5 Participants
|
322 Participants
n=7 Participants
|
443 Participants
n=5 Participants
|
|
Relationship to Child
Father
|
10 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Relationship to Child
Grandparent
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Highest Education Level Achieved
High School or less
|
33 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Highest Education Level Achieved
Trade School or Associates Degree
|
20 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Highest Education Level Achieved
Bachelors Degree
|
43 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Highest Education Level Achieved
Graduate or Professional School
|
36 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Children in Household
1 Child (Study Child)
|
36 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Children in Household
2 Children
|
50 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Children in Household
3 Children
|
33 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Children in Household
4 Children or more
|
13 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Child Age Category
6 months to <3 years
|
58 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Child Age Category
3 years to <5 years
|
25 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Child Age Category
5 years through 10 years
|
49 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Child Sex
Male
|
78 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Child Sex
Female
|
54 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Child Race and Ethnicity
Black, not Hispanic/Latine
|
11 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Child Race and Ethnicity
Hispanic/Latine
|
60 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Child Race and Ethnicity
White, not Hispanic/Latine
|
37 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Child Race and Ethnicity
Other or multiple races, not Hispanic/Latine
|
24 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Baseline Child Passenger Safety Behavior
Not using recommended child passenger restraint or rides in front seat
|
94 Participants
n=5 Participants
|
247 Participants
n=7 Participants
|
341 Participants
n=5 Participants
|
|
Baseline Child Passenger Safety Behavior
Planning a premature transition to a less protective restraint in the next 6 months
|
38 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-Month AssessmentAt 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
Outcome measures
| Measure |
Phase 1: Enhanced Usual Care
n=118 Participants
Participants were randomized after completion of the baseline survey and received a basic information sheet (print or electronic).
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.
|
Phase 1: Basic Intervention
n=278 Participants
Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) 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 2x/month.
Months 1-6: Participants received four unscheduled requests to submit photographs as their child usually travels and received tailored feedback.
Outcomes were assessed at 6-month follow-up.
|
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.
|
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.
|
|---|---|---|---|---|
|
Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 6 Months
|
38 Participants
|
131 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 12-Month AssessmentAt 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
Outcome measures
| Measure |
Phase 1: Enhanced Usual Care
n=111 Participants
Participants were randomized after completion of the baseline survey and received a basic information sheet (print or electronic).
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.
|
Phase 1: Basic Intervention
n=77 Participants
Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) 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 2x/month.
Months 1-6: Participants received four unscheduled requests to submit photographs as their child usually travels and received tailored feedback.
Outcomes were assessed at 6-month follow-up.
|
Phase 2: Re-Randomized to Continue Basic Intervention (mHealth)
n=84 Participants
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.
|
Phase 2: Re-Randomized to Enhanced Intervention (Booster MI Session)
n=87 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 12 Months
|
43 Participants
|
59 Participants
|
40 Participants
|
39 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-Month AssessmentWe 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-Month AssessmentAt 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.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: 6-Month AssessmentAt 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
Outcome measures
| Measure |
Phase 1: Enhanced Usual Care
n=118 Participants
Participants were randomized after completion of the baseline survey and received a basic information sheet (print or electronic).
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.
|
Phase 1: Basic Intervention
n=278 Participants
Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) 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 2x/month.
Months 1-6: Participants received four unscheduled requests to submit photographs as their child usually travels and received tailored feedback.
Outcomes were assessed at 6-month follow-up.
|
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.
|
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.
|
|---|---|---|---|---|
|
Number of Participants With Age- and Size-Appropriate Child Passenger Restraint System Use at 6 Months
|
52 Participants
|
156 Participants
|
—
|
—
|
POST_HOC outcome
Timeframe: 12-Month AssessmentAt 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
Outcome measures
| Measure |
Phase 1: Enhanced Usual Care
n=111 Participants
Participants were randomized after completion of the baseline survey and received a basic information sheet (print or electronic).
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.
|
Phase 1: Basic Intervention
n=77 Participants
Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) 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 2x/month.
Months 1-6: Participants received four unscheduled requests to submit photographs as their child usually travels and received tailored feedback.
Outcomes were assessed at 6-month follow-up.
|
Phase 2: Re-Randomized to Continue Basic Intervention (mHealth)
n=84 Participants
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.
|
Phase 2: Re-Randomized to Enhanced Intervention (Booster MI Session)
n=87 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Age- and Size-Appropriate Child Passenger Restraint System Use at 12 Months
|
59 Participants
|
65 Participants
|
46 Participants
|
49 Participants
|
Adverse Events
Phase 1: Enhanced Usual Care (EUC)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 1: Intervention
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 2: Enhanced Usual Care (EUC)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 2: Guideline Adherent at 6-month Follow-up
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 2: Re-Randomized to Continue Basic Intervention (mHealth)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 2: Re-Randomized to Enhanced Intervention (Booster MI Session)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase 1: Enhanced Usual Care (EUC)
n=118 participants at risk
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.
|
Phase 1: Intervention
n=274 participants at risk
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.
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Phase 2: Enhanced Usual Care (EUC)
n=111 participants at risk
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.
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Phase 2: Guideline Adherent at 6-month Follow-up
n=77 participants at risk
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.
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Phase 2: Re-Randomized to Continue Basic Intervention (mHealth)
n=84 participants at risk
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.
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Phase 2: Re-Randomized to Enhanced Intervention (Booster MI Session)
n=87 participants at risk
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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General disorders
Possible Delayed Transition
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1.7%
2/118 • Number of events 2 • Through study completion, an average of 1 year.
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2.6%
7/274 • Number of events 7 • Through study completion, an average of 1 year.
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0.90%
1/111 • Number of events 1 • Through study completion, an average of 1 year.
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3.9%
3/77 • Number of events 3 • Through study completion, an average of 1 year.
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2.4%
2/84 • Number of events 2 • Through study completion, an average of 1 year.
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4.6%
4/87 • Number of events 4 • Through study completion, an average of 1 year.
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Additional Information
Dr. Michelle Macy
Ann & Robert H. Lurie Children's Hospital of Chicago
Phone: 312-227-6676
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place