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Study identifier: NCT06817746 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Telehealth Intervention for Infants With Prodromes of ASD

Condition: Autism Spectrum Disorder (ASD)  ·  Sponsor: IRCCS Fondazione Stella Maris

PhaseNA
Planned participants132
Who can joinAll sexes, 9 Months to 17 Months
Healthy volunteersNo

About this study

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 prodrom…

This description comes directly from the study's public registry record.

Talk to the study team

Andrea Guzzetta, MD  ·  andrea.guzzetta@fsm.unipi.it

Costanza Colombi, PhD  ·  050 886382  ·  costanza.colombi@fsm.unipi.it

Always discuss trial participation with your own doctor first.

Locations (4)

IRCCS Stella MarisPisa, Italy, ItalyRecruiting
Istituto Italiano TecnologiaRovereto, Italy, ItalyActive Not Recruiting
CNRMessina, ItalyRecruiting
University of MessinaMessina, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT06817746