Mary Ann & J. Milburn Smith Child Health Outcomes, Research and Evaluation Center and Division of Emergency Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Injury Prevention Center, University of Michigan, Department of Health Behavior and Health Education, School of Public Health, Department of Emergency Medicine, Michigan Medicine, Ann Arbor, MI, USA.
Contemp Clin Trials. 2022 Sep;120:106863. doi: 10.1016/j.cct.2022.106863. Epub 2022 Jul 30.
Motor vehicle collisions remain a leading cause of unintentional injury deaths among children in the United States despite the proven effectiveness of child restraint systems (CRS). Laws and public education campaigns have fallen short of ensuring child passenger safety guideline adherence (i.e., correct use of a size-appropriate CRS in the back seat on every trip) across the population.
This randomized controlled trial will test the efficacy of Tiny Cargo, Big Deal!/Abróchame Bien, Cuídame Bien (TCBD/ABCB), a precision prevention intervention, grounded in Self-Determination Theory, that integrates motivational interviewing and tailored eHealth components to promote child passenger safety guideline adherence over the course of one year. Using in-person and remote recruitment, we seek to enroll 900 English or Spanish-speaking adult caregivers of children 6 months to 10 years of age who sought emergency or urgent care and screened non-adherent to child passenger safety guidelines. Eligible caregivers provide informed consent and complete a baseline assessment before randomization. At 6 months, only intervention group participants who remain non-adherent are re-randomized to standard or enhanced intervention. We assess caregiver-submitted photographs throughout the year using the Child Passenger Safety Score and provide personalized feedback. The primary outcome of guideline adherence is assessed at 12-months. The trial has been registered with clinicaltrials.gov: NCT04238247.
We hypothesize TCBD/ABCB will be more efficacious than enhanced usual care for promoting guideline adherence at 12-month follow-up. The intervention is expected to benefit children in families who have not responded to legal requirements and population-based strategies for child passenger safety.
尽管儿童约束系统（CRS）已被证明有效，但机动车碰撞仍是美国儿童意外伤害死亡的主要原因。法律和公众教育活动未能确保儿童乘客安全指南（即在每次乘车时在后座正确使用适合尺寸的 CRS）得到普遍遵守。
这项随机对照试验将测试 Tiny Cargo，Big Deal!/Abróchame Bien，Cuídame Bien（TCBD/ABCB）的功效，这是一种基于自我决定理论的精准预防干预措施，将动机访谈和量身定制的电子健康组件相结合，以促进儿童乘客安全指南在一年内得到遵守。我们通过面访和远程招募，希望招募到 900 名英语或西班牙语的 6 个月至 10 岁儿童的成年照顾者，这些照顾者在寻求紧急或紧急护理时被发现未遵守儿童乘客安全指南。符合条件的照顾者在随机分组前提供知情同意并完成基线评估。在 6 个月时，只有仍未遵守指南的干预组参与者会被重新随机分配到标准或增强干预组。我们全年使用儿童乘客安全评分评估照顾者提交的照片，并提供个性化反馈。12 个月时评估指南遵守情况作为主要结局。该试验已在 clinicaltrials.gov 上注册：NCT04238247。
我们假设 TCBD/ABCB 将比增强常规护理更有效，以促进 12 个月随访时的指南遵守。预计该干预措施将使未对儿童乘客安全的法律要求和基于人群的策略做出反应的家庭中的儿童受益。
