🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Group CBT in Adolescents With Fragile X Syndrome and in Adolescents With Autism Spectrum Disorder

RecruitingNAAges 13 Years - 19 YearsAllBambino Gesù Hospital and Research Institute
NCT06677866 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

Fragile X Syndrome (FXS) is a rare genetic syndrome, caused by a mutation in the FMR1 gene located on the X chromosome. It is considered the leading hereditary cause of intellectual disability (ID) and the primary cause of Autism Spectrum Disorder (ASD) due to a single gene-mutation. Many individuals with FXS exhibit symptoms overlapping with those of ASD, including difficulties in social-communication skills, challenges in peer relationships, restricted and repetitive behaviors/interests and deficits in adaptive functioning. Both in ASD and FXS, individuals with greater deficits in executive functions, socio-pragmatic, and socio-relational skills also demonstrate lower adaptive functioning and, consequently, reduced autonomy/independence throughout the life course and greater severity of the disorder. Among empirically validated treatments recommended by National and International Guid

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
FXS group: Inclusion Criteria * Clinical diagnosis of FXS confirmed by genetic testing. * Age between 13 and 19 years. * Language skills compatible with group intervention (verbal language at sentence level). * Impairment in adaptive functioning measured by VABS II \< 70. * Informed consent for participation and data processing provided by parents. Exclusion Criteria * Severe visual or hearing impairments. * Diagnosis of epilepsy or a history of seizures requiring medication. * Participation in other non-pharmacological treatments. * Changes in pharmacological therapy within the last 3 months. * Presence of medical problems or behaviors that could interfere with group activities, as measured by the Autism Behavior Checklist (ABC) (ABC Irritability Scale \< 18). * IQ \< 40 measured by the Leiter third edition (Leiter 3) * Severe adaptive functioning, measured by VABS II \< 20. ASD group: Inclusion Criteria * Clinical diagnosis of Autism Spectrum Disorder (ASD) confirmed by ADOS-2 and ADI-R interviews. * Age between 13 and 19 years. * Language skills compatible with group intervention (verbal language at sentence level). * Impairment in adaptive functioning measured by VABS II \< 70. * Informed consent for participation and data processing provided by parents. Exclusion Criteria * Severe visual or hearing impairments. * Identification of specific genetic abnormalities or presence of known genetic syndromes associated with ASD (e.g., TSC, FXS, 22q11, 16p11.2, Rett Syndrome). * Diagnosis of epilepsy or a history of seizures requiring medication. * Participation in other non-pharmacological treatments. * Changes in pharmacological therapy within the last 3 months. * Presence of medical problems or behaviors that could interfere with group activities, as measured by the Autism Behavior Checklist (ABC) (ABC Irritability Scale \< 18). * IQ \< 40 measured by the Leiter third edition (Leiter 3) * Severe adaptive functioning, measured by VABS II \< 20.
💊

What it tests

  • Cognitive behavioral therapy
  • Waiting List
📍

Where

1 site
Bambino Gesù Children's Hospital
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy