Telehealth support for infants showing early signs of autism
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
Run by IRCCS Fondazione Stella Maris · NCT06817746 · Data updated 2026-11-12
This study is testing whether telehealth support can help infants under 18 months who show early signs of autism develop better skills and reduce their symptoms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 9 Months to 17 Months |
| Sex | All |
| Enrollment | 132 (estimated) |
| Sponsor | IRCCS Fondazione Stella Maris Academic / other |
| Locations | 4 sites (Pisa, Italy and 3 other locations) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | February 10, 2025 |
| Trial ID | NCT06817746 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants under 18 months who show early signs of ASD and have access to a webcam and internet.
✕Probably not a fit
Patients with known genetic disorders, significant neurological impairments, or severe sensory/motor disabilities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This intervention focuses on providing pre-emptive support for infants who exhibit early prodromal signs of Autism Spectrum Disorder (ASD). The approach involves telehealth methods, including parent education and the FIRRST program, to enhance developmental skills and potentially mitigate the progression of ASD symptoms. By targeting infants under 18 months with specific risk factors, the study aims to leverage the critical period of brain plasticity for optimal outcomes. The intervention is designed to be accessible through devices with webcams and internet access, facilitating remote participation.
Why it matters
Potential benefit: If successful, this intervention could lead to improved developmental outcomes and reduced symptoms of ASD in infants.
How similar studies have gone: Previous studies have indicated that early interventions for ASD can lead to better outcomes, suggesting that this approach may be promising.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
IRCCS Stella Maris
Pisa, Italy, Italy Recruiting -
Cnr
Messina, Italy Recruiting -
University of Messina
Messina, Italy Recruiting -
Istituto Italiano Tecnologia
Rovereto, Italy, Italy Active not recruiting
Study contacts
- Principal investigator: Andrea Guzzetta, MD — University of Pisa/IRCCS Stella Maris
- Study coordinator: Andrea Guzzetta, MD
- Email: andrea.guzzetta@fsm.unipi.it
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.