Cognitive Behavioral Therapy for Adolescents with Fragile X Syndrome and Autism Spectrum Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of cognitive behavioral therapy (CBT) in improving adaptive functioning and quality of life in adolescents diagnosed with Fragile X Syndrome (FXS) and Autism Spectrum Disorder (ASD). Participants aged 13 to 19 years will be enrolled based on specific inclusion criteria, including a confirmed clinical diagnosis and certain levels of adaptive functioning. The study aims to address overlapping symptoms of FXS and ASD, such as social-communication difficulties and restricted behaviors, through a structured group intervention. The intervention will be compared to a waiting list control group to assess its impact on the participants' skills and overall well-being.

Why it matters

Who can join: the full rules

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.

Where it's running

• Bambino Gesù Children's Hospital
  Rome, Italy Recruiting

Study contacts

• Principal investigator: Paolo Alfieri, MD, PhD — Bambino Gesù Children's Hospital
• Study coordinator: Alice Federica M Montanaro, PsyD
• Email: federica.montanaro@opbg.net
• Phone: 06/68597009

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.