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New treatment option for Fragile X Syndrome (FXS)
Official title Group CBT in Adolescents With Fragile X Syndrome and in Adolescents With Autism Spectrum Disorder
ClinicalTrials.gov ID: NCT06677866
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 19
You may be able to join if
- FXS group:
- 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.
You likely can't join if
- 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...
- IQ \< 40 measured by the Leiter third edition (Leiter 3)
See the full eligibility criteria
- FXS group:
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 19 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.