Barbaro Josephine, Masi Anne, Gilbert Melissa, Nair Radhika, Abdullahi Ifrah, Descallar Joseph, Dissanayake Cheryl, Eastwood John, Hasan Iqbal, Jalaludin Bin, Karlov Lisa, Khan Feroza, Kohlhoff Jane, Liaw S T, Lingam Raghu, Mendoza Diaz Antonio, Ong Natalie, Tam Chun Wah Michael, Unwin Katy, Woolfenden Sue, Eapen Valsamma
Olga Tennison Autism Research Centre, School of Psychology and Public Health, College of Science, Health & Engineering, La Trobe University, Bundoora, VIC, Australia.
Cooperative Research Centre for Living With Autism (Autism CRC), The University of Queensland, Indooroopilly, QLD, Australia.
Front Pediatr. 2021 Apr 23;9:640359. doi: 10.3389/fped.2021.640359. eCollection 2021.
The early detection of developmental conditions such as autism is vital to ensure children can access appropriate and timely evidence-based supports, services, and interventions. Children who have undetected developmental conditions early in life are more likely to develop later health, developmental, learning, and behavioral issues, which in turn can have a cumulative effect over the life course. The current protocol describes a multi-site, cluster randomized control trial comparing a developmental surveillance pathway for autism to usual care, using opportunistic visits to general practitioners (GPs). Units of randomization are GP clinics across two Australian states (New South Wales and Victoria), with thirty clinics within each state, each of which will aim to recruit approximately forty children aged between ~18- and 24-months, for a total of ~2,400 participants. Children will be randomized to two clusters; namely, an autism surveillance pathway (ASP) or surveillance as usual (SaU). The screening process for the ASP arm involves primary and secondary screenings for developmental concerns for autism, using both parent and GP reports and observations. Children in both arms who show signs of developmental concerns for autism will be offered a full developmental assessment by the research team at 24 months of age to determine the efficacy of developmental surveillance in successfully identifying children with autism. The trial is registered with ANZCTR (ACTRN12619001200178) and reporting of the trial results will be according to recommendations in the CONSORT Statement.
早期发现自闭症等发育状况对于确保儿童能够获得适当、及时的循证支持、服务和干预至关重要。在生命早期未被发现有发育状况的儿童更有可能在日后出现健康、发育、学习和行为问题，而这些问题反过来又可能在整个生命过程中产生累积影响。当前方案描述了一项多中心、整群随机对照试验，该试验将自闭症发育监测途径与常规护理进行比较，利用对全科医生（GP）的机会性就诊。随机分组单位是澳大利亚两个州（新南威尔士州和维多利亚州）的全科医生诊所，每个州有30个诊所，每个诊所的目标是招募约40名年龄在18至24个月之间的儿童，总共约2400名参与者。儿童将被随机分为两组；即自闭症监测途径（ASP）组或常规监测（SaU）组。ASP组的筛查过程包括使用家长和全科医生的报告及观察结果对自闭症发育问题进行一级和二级筛查。两组中表现出自闭症发育问题迹象的儿童将在24个月大时由研究团队进行全面发育评估，以确定发育监测在成功识别自闭症儿童方面的效果。该试验已在澳大利亚和新西兰临床试验注册中心（ANZCTR，注册号：ACTRN12619001200178）注册，试验结果将按照CONSORT声明中的建议进行报告。
