Rare Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
For participants with Fragile X Syndrome (FXS):
Who might be able to join this trial:
- The participant has been diagnosed with Fragile X Syndrome (FXS), confirmed by a genetic test.
- The participant is between 13 and 19 years old.
- The participant can communicate verbally using sentences (enough to take part in group activities).
- The participant has difficulties with everyday living skills, as measured by a standard assessment called VABS II, with a score below 70.
- A parent or guardian has given written consent for their child to participate and for their data to be used.
Who may not be able to join:
- The participant has serious problems with their vision or hearing.
- The participant has been diagnosed with epilepsy or has had seizures that require medication.
- The participant is currently receiving another non-medication-based therapy or treatment.
- The participant's medication has been changed in the last 3 months.
- The participant has health issues or challenging behaviours that could disrupt group activities, based on a specific behaviour checklist score (confirm with trial site).
- The participant has an IQ score below 40, as measured by a specific intelligence test called the Leiter-3.
- The participant has very severely limited everyday living skills, with a VABS II score below 20.
For participants with Autism Spectrum Disorder (ASD):
Who might be able to join this trial:
- The participant has been diagnosed with Autism Spectrum Disorder (ASD), confirmed through recognised professional assessment tools.
- The participant is between 13 and 19 years old.
- The participant can communicate verbally using sentences (enough to take part in group activities).
- The participant has difficulties with everyday living skills, as measured by a standard assessment called VABS II, with a score below 70.
- A parent or guardian has given written consent for their child to participate and for their data to be used.
Who may not be able to join:
- The participant has serious problems with their vision or hearing.
- The participant has been identified as having a specific genetic condition associated with autism, such as Tuberous Sclerosis, Fragile X Syndrome, Rett Syndrome, or certain chromosomal differences (confirm with trial site for full list).
- The participant has been diagnosed with epilepsy or has had seizures that require medication.
- The participant is currently receiving another non-medication-based therapy or treatment.
- The participant's medication has been changed in the last 3 months.
- The participant has health issues or challenging behaviours that could disrupt group activities, based on a specific behaviour checklist score (confirm with trial site).
- The participant has an IQ score below 40, as measured by a specific intelligence test called the Leiter-3.
- The participant has very severely limited everyday living skills, with a VABS II score below 20.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Paolo Alfieri, MD, PhD, Bambino Gesù Children's Hospital
Phone: 06/68597009
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Global Clinical Impression - Severity Scale (CGI-S)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.