摘要：Objectives. We sought to identify the program fidelity factors associated with successful implementation of the Buckle-Up Safely program, targeting correct use of age-appropriate child car restraints. Methods. In 2010, we conducted a cluster randomized controlled trial of 830 families with children attending preschools and long day care centers in South West Sydney, New South Wales, Australia. Families received the Buckle-Up Safely program in the intervention arm of the study (13 services). Independent observers assessed the type of restraint and whether it was used correctly. Results. This detailed process evaluation showed that the multifaceted program was implemented with high fidelity. Program protocols were adhered to and messaging was consistently delivered. Results from multilevel and logistic regression analyses show that age-appropriate restraint use was associated with attendance at a parent information session hosted at the center (adjusted odd ratio [AOR] = 3.66; 95% confidence interval [CI] = 1.61, 8.29) and adversely affected by the child being aged 2 to 3 years (AOR = 0.14; 95% CI = 0.07, 0.30) or being from a family with more than 2 children (AOR = 0.34; 95% CI = 0.17, 0.67). Conclusions. Findings highlight the importance of parents receiving hands-on education regarding the proper use of age-appropriate child restraints. Road traffic injury remains a leading cause of death and injury worldwide. 1 Young children are particularly vulnerable. 2 The protective effects of using child car restraints have been known for decades. 3–9 Legislation introduced into New South Wales, Australia, in 2010 amended previous legislation and mandated the use of age-appropriate child car restraints. 10 Under this legislation, children aged 0 to 6 months must be in a rear-facing child car restraint, children aged 6 months up to 4 years must travel in a rear-facing or forward-facing child restraint and children aged up to 7 years must travel in either a forward-facing child car restraint or a booster seat. 11 For the purposes of this article, child car restraints are defined as per the Australian Standards (AS/NZS: 1754 2010) 12 and appropriate use as per the legislation. Researchers have implemented and evaluated programs targeting increased use of size- or age-appropriate child car restraints 13–16 and their correct use. 16,17 A 2006 Cochrane systematic review of interventions targeting booster seat use in children aged 4 to 8 years concluded that interventions should be multifaceted. 18 Not all programs have been successful. A recent, large-scale trial based in child care centers in the United States found no improvement in child booster seat use among 1010 children aged 4 to 8 years following a multifaceted education program including distribution of free booster seats. 13 The authors concluded that further work was needed to identify effective methods and messages. That study would have likely benefitted from a detailed process evaluation to identify effective elements of the program and to assess program fidelity. Process evaluations of injury prevention and safety promotion strategies are not routinely reported beyond a presentation of the proportion of people exposed to the intervention and perhaps to report factors that negatively affected program implementation. 19 More often more detailed process evaluations accompany articles reporting a null effect, in an attempt to explain the result. 19,20 In the pursuit of greater efficiency and more targeted effectiveness of interventions, there is increasing demand from research grant providers and program planners to ensure evaluations include a greater emphasis on process evaluations. In 2004 Bellg et al., as part of the Treatment Fidelity Workgroup of the National Institutes of Health Behavior Change Consortium, presented recommendations to build treatment (or program) fidelity into health behavior intervention research. 19 Those recommendations addressed elements of study design, provider training, treatment delivery, treatment receipt, and treatment enactment. 21 Earlier process evaluations focused on formative evaluations to guide program development. Recently there has been increasing interest in summative process evaluations. These draw on measures of program fidelity (such as adherence, dose, quality of program delivery, participant responsiveness, and program differentiation) 22,23 that are then combined with program outcomes to provide insight into how the program implementation affected the study outcome. Summative process evaluations can minimize chances of a Type II error. 20 An example of a Type II error would be one in which an evaluation finds no difference between the intervention and control groups when an effect may have been seen had the program been implemented as designed. Examining program fidelity in pragmatic trials also gives an indication of how likely it is that the program could be implemented as intended beyond the study population. 22 A robust process evaluation can assess factors that may affect the uptake of the program in a given setting, such as attitudes of service providers toward the program or consistent delivery of key messages. As such, this can then inform practitioners and policymakers when planning to disseminate programs more broadly. In 2010 we conducted a cluster randomized controlled trial in South West Sydney, New South Wales, Australia, targeting increased use of age-appropriate child car restraints and decreased misuse in children aged 3 to 5 years. The intervention program, called Buckle-Up Safely, was shown to be highly effective, particularly among families in which English was not the main language spoken at home. 16 In this article, we aim to identify the program fidelity factors associated with successful implementation of the Buckle-Up Safely program.
