Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
NCT ID:
NCT06677866
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
19 Years
Study:
NCT06677866
Study Brief:
Protocol Section:
NCT06677866