NCT06817746 Telehealth Intervention for Infants With Prodromes of ASD
| NCT ID | NCT06817746 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Fondazione Stella Maris |
| Condition | Autism Spectrum Disorder (ASD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 132 participants in total. It began in 2024-11-01 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Andrea Guzzetta, MD
✉ andrea.guzzetta@fsm.unipi.itAndrea Guzzetta, MD
PRINCIPAL INVESTIGATOR
University of Pisa/IRCCS Stella Maris
Frequently Asked Questions
Who can join the NCT06817746 clinical trial?
This trial is open to participants of all sexes, aged 9 Months or older, up to 17 Months, studying Autism Spectrum Disorder (ASD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06817746 currently recruiting?
Yes, NCT06817746 is actively recruiting participants. Contact the research team at andrea.guzzetta@fsm.unipi.it for enrollment information.
Where is the NCT06817746 trial being conducted?
This trial is being conducted at Pisa, Italy, Rovereto, Italy, Messina, Italy, Messina, Italy.
Who is sponsoring the NCT06817746 clinical trial?
NCT06817746 is sponsored by IRCCS Fondazione Stella Maris. The principal investigator is Andrea Guzzetta, MD at University of Pisa/IRCCS Stella Maris. The trial plans to enroll 132 participants.