Clinical trial NCT06817746: Telehealth Intervention for Infants With Prodromes of ASD
Official title: Fostering Infant Responsivity and Reciprocity - Support to Thrive. A Multisite Randomized Control Trial of a Preemptive Telehealth Intervention for Infants With Early Signs of Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder (ASD)
Keywords: Autism Spectrum Disorder (ASD)
ASD Prodromes
Infants
Support
Pre-emptive
Parent Mediated
Lead sponsor: IRCCS Fondazione Stella Maris
Sponsor class: OTHER
Collaborators: name: Policlinico Hospital/University of Messina
name: CNR Messina
name: Istituto Italiano di Tecnologia
First posted: 2025-02-10
Enrollment: 132
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* risk-range score at SACS-R;
* Italian as one of the languages spoken at home;
* age below 18 months (corrected) at the time of identification;
* available device with webcam and home internet access.

Exclusion criteria:

* presence of a known genetic disorder, brain damage or other relevant neurological or chronic disorders;
* severe visual, auditory and/or motor impairment.

Primary outcomes:
measure: Infant Development
timeFrame: T0: at recruitment; T1: after 6 months since recruitment; T2: after 12 months since recruitment.
measure: ASD Symptom Severity
timeFrame: T0: at recruitment; T1: after 6 months since recruitment; T2: after 12 months since recruitment.
measure: Change of Core ASD Symptoms
timeFrame: T0: at recruitment; T1: after 6 months since recruitment; T2: after 12 months since recruitment.
Secondary outcomes:
measure: Parent Mental Well-Being
timeFrame: T0: at recruitment: T1: after 6 months since recruitment; T2: after 12 months since recruitment.
measure: Parent-Child Interaction
timeFrame: T0: at recruitment; T1: after 6 months since recruitment; after 12 months since recruitment.
measure: Neurophysiological Modifications
timeFrame: To: at recruitment; T1: after 6 months since recruitment; T2: after 12 months since recruitment.
Other outcomes:
Locations:
city: Messina
country: Italy
facility: CNR
city: Messina
country: Italy
facility: University of Messina
city: Pisa
country: Italy
facility: IRCCS Stella Maris
city: Rovereto
country: Italy
facility: Istituto Italiano Tecnologia
Study officials:
affiliation: University of Pisa/IRCCS Stella Maris
name: Andrea Guzzetta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pisa/IRCCS Stella Maris
name: Sara Calderoni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Stella Maris
name: Costanza Colombi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CNR Messina
name: Lilian Ruta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Messina
name: Gabriella Di Rosa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Italiano Tecnologia
name: Michale Lombardo, PhD
role: PRINCIPAL_INVESTIGATOR
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