Autism Spectrum Disorder (ASD) is a complex neurodevelopmental disorder characterized by
social-communication and interaction deficits and restricted, repetitive patterns of
interests and behavior. It is frequently associated with heterogeneous comorbidities
including physical, mental, and neurodevelopmental disorders, which can result in a
substantial burden on individuals, families, and society.
Early prodromal signs of ASD emerge during the first year of life, a time when brain
plasticity is at its maximum level, and may consist of diminished social orienting,
responsivity and reciprocity combined with the presence of prolonged visual fixation and
repetitive use of objects. Developmental immaturities in communication and motor skills
are often present too. Pre-emptive Intervention (PI) for infants with prodromal signs of
ASD was shown to improve outcomes, in comparison to later starts, by improving
developmental skills, reducing ASD symptoms and, in some cases, preventing the full blown
symptoms of ASD. Moreover, access to early evidence-based interventions may reduce the
elevated levels of stress, anxiety and depressive symptoms experienced by caregivers of
children with signs of ASD.
Despite this evidence, professionals tend to have a 'wait to see' approach, rather than
targeting areas of impairment with early intervention. Moreover, the vast majority of
current clinical models of ASD services require a diagnosis to receive services, while
the identification of prodromal signs of the disorders generally is not sufficient to
access early intervention. There is an urgent need for a paradigm shift in ASD treatment.
The proposed Project aims to evaluate the efficacy of FIRRST, a parent-mediated PI for
infants with early signs of ASD. We will conduct a multisite RCT of telehealth PI by
recruiting 132 symptomatic infants between 9-14 months and randomly assigning them to
receive either FIRSST (experimental group), or Parent Education (control group).
Developmental skills, ASD symptomatology, caregiver well-being and brain changes on
High-Density EEG will be assessed with in-presence evaluations at three time points: 1.
baseline; 2. after 24 weeks of intervention; 3. follow-up after 24 weeks from the end of
intervention.
If funded, The proposed study will be the first well-powered RCT evaluating
developmental, symptom and neurophysiological changes in response to a parent-mediated PI
conducted in Europe. The ultimate goal for translational research in ASD lies in the
optimization of clinical outcomes through the most effective, targeted, and timely
treatments. The proposed RCT has the potential to significantly impact current access to
services by reducing the age of starting intervention, thereby promoting optimal
developmental outcomes, as well as reducing burden and high health costs to families and
society.