Tiny Cargo, Big Deal! An Adaptive ED-Based eHealth Intervention to Promote Correct and Consistent Size-Appropriate Child Passenger Safety Behaviors and Reduce Disparities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 513
- 试验地点
- 1
- 主要终点
- Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 6 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 6 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Enhanced Usual Care
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
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.
干预措施: Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention (Behavioral)
Enhanced Intervention
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.
干预措施: Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention (Behavioral)
Enhanced Intervention
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.
干预措施: Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Enhanced Intervention (Behavioral)
结局指标
主要结局
Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 6 Months
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Michelle Macy, MD
Director, Mary Ann & J. Milburn Smith Child Health Outcomes, Research, and Evaluation Center
Ann & Robert H Lurie Children's Hospital of Chicago