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Search / Trial NCT06817746

Telehealth Intervention for Infants With Prodromes of ASD

Launched by IRCCS FONDAZIONE STELLA MARIS · Feb 4, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Autism Spectrum Disorder (Asd) Asd Prodromes Infants Support Pre Emptive Parent Mediated

ClinConnect Summary

This clinical trial is studying a new approach to help infants who show early signs of Autism Spectrum Disorder (ASD). The goal is to see if a special program called FIRRST, which parents can use at home through telehealth (video calls), can improve the developmental skills of infants aged 9 to 14 months who are at risk for ASD. The trial will involve 132 infants who will be divided into two groups: one group will receive the FIRRST program, and the other will get general parent education. Researchers will check the infants’ development, symptoms of ASD, and even brain activity at different points during and after the program.

To participate, infants must be under 18 months old at the time of enrollment, speak Italian at home, and show certain early signs of ASD. They also need to have access to a device with a webcam and the internet. However, infants with specific genetic or neurological disorders, or severe sensory impairments, cannot participate. This study is important because it aims to provide early support for children at risk for ASD, potentially leading to better outcomes for them and reducing stress for their families.

Gender

ALL

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.

About Irccs Fondazione Stella Maris

IRCCS Fondazione Stella Maris is a leading Italian research institute dedicated to advancing the field of child and adolescent neuropsychiatry. As an IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), it is recognized for its commitment to integrating clinical care with cutting-edge scientific research. The foundation focuses on understanding and treating various neurodevelopmental disorders through innovative clinical trials, multidisciplinary collaboration, and a patient-centered approach. With a mission to improve the mental health and well-being of young patients, IRCCS Fondazione Stella Maris plays a pivotal role in shaping the future of pediatric psychiatry in Italy and beyond.

Locations

Messina, , Italy

Pisa, , Italy

Messina, , Italy

Rovereto, , Italy

Patients applied

0 patients applied

Trial Officials

Andrea Guzzetta, MD

Principal Investigator

University of Pisa/IRCCS Stella Maris

Sara Calderoni, MD

Principal Investigator

University of Pisa/IRCCS Stella Maris

Costanza Colombi, PhD

Principal Investigator

IRCCS Stella Maris

Lilian Ruta, MD

Principal Investigator

CNR Messina

Gabriella Di Rosa, MD

Principal Investigator

University of Messina

Michale Lombardo, PhD

Principal Investigator

Istituto Italiano Tecnologia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported