Autism Spectrum Disorder Clinical Trials

A growing body of literature documents the benefits of parent-mediated interventions for autism starting early in life . However, the median age of diagnosis in the US continues to be 49 months. Even following formal diagnosis, services often do not begin for another 9 months on average. Such harmful delays in accessing autism-specific early interventions are potentially avoidable, as caregivers of children later diagnosed with autism identify concerns about their child's development by 13 months on average - including difficulties that can be successfully addressed through evidence-based intervention practices. Wait times to receive a formal diagnosis of autism are such a significant barrier that they have been referred to as a crisis in the field, with parents reporting an average wait time of 1.2 years in the US. The current proposal focuses on circumventing the roadblock of delayed access to diagnosis and intervention by empowering caregivers to address their children's needs before a diagnosis is established. This will be accomplished through the implementation and evaluation of the Online Parent Training in Early Behavioral Intervention (OPT-In-Early), a self-directed online resource for caregivers of autistic children which will be made available during their enrollment in waitlists for a diagnostic evaluation. Key features of OPT-In-Early include: (a) a comprehensive scope (i.e., multiple developmental domains are addressed), (b) a focus on evidence-based Naturalistic Developmental Behavioral Intervention strategies, (c) a combination of required and optional modules, so that caregivers can focus on areas most relevant to their child's needs, and (d) access to online materials designed for self-directed implementation, as well as access to remote consultation with a clinician for advice, clarification and support (including on selection of appropriate modules). Following an alternative approach to the current parental concerns - then enrollment in waitlist - then clinical diagnosis - then intervention, the program is designed to counteract the harmful and frustrating inaction that characterizes the waitlist time with timely action designed to address areas of concern that caregivers have already identified and should be empowered to address. This has the potential to capitalize on the window of opportunity of early brain plasticity, thus maximizing outcomes, and to reduce the anxiety associated with the lack of services that characterizes the period of passive waiting for a formal diagnosis. To evaluate the utility of this innovative resource, the following specific aims will be addressed: 1. Comparing outcomes for 120 toddlers aged 16-48 months whose caregivers are on a waitlist to receive a formal autism diagnosis, randomly assigned to receive either OPT-In-Early or no intervention during a six-month period. The investigators predict that (a) children randomized to the OPT-In-Early condition will have superior gains as reflected in the Goal Attainment Scaling, changes in adaptive behavior and social communication standardized measures, and (b) their families will experience superior improvements in their well-being. 2. Examining implementation outcomes of feasibility and acceptability of the intervention. The investigators predict high acceptability and feasibility for the OPT-In-Early content and format, as indicated by end-users' responses to standardized measures reflecting 80%+ agreement on the feasibility and acceptability of the program. 3. As an exploratory aim, investigators will examine theoretically- and empirically- motivated factors associated with intervention uptake and child outcomes, including demographic profiles and child clinical presentation. Examining whether accessing and using OPT-In-Early during waitlist time is a viable alternative to the current first diagnosis then intervention format (for all children, or for children with specific profiles and needs) is a critical step toward promoting a more efficient intervention delivery model, bridging the gap between onset of parental concerns and availability of intervention practices designed to target such concerns.