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This study examines group cognitive behavioral therapy in adolescents with Fragile X syndrome and in adolescents with autism spectrum disorder. Adolescents aged 13-19 with genetically confirmed Fragile X syndrome or ADOS-2/ADI-R-confirmed autism, and language skills suitable for group work, may take part. It is a non-phase study that is currently recruiting.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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.