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

Effectiveness of Cooperative Group Therapy in Adolescents With Fragile X Syndrome (FXS) and in Adolescents With Autism Spectrum Disorder (ASD)

This study is testing whether cognitive behavioral therapy can help teenagers with Fragile X Syndrome and Autism Spectrum Disorder improve their daily skills and overall quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 13 Years to 19 Years
• Sex: All
• Sponsor: Bambino Gesù Hospital and Research Institute (Academic / other)
• Locations: 1 site (Rome)
• Trial ID: NCT06677866 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adolescents aged 13 to 19 years with a clinical diagnosis of FXS or ASD and specific impairments in adaptive functioning.

Not a fit: Patients with severe visual or hearing impairments, significant medical issues, or those who have recently changed pharmacological therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly enhance the adaptive functioning and quality of life for adolescents with FXS and ASD.

How similar studies have performed: Previous studies have shown that cognitive-behavioral and psychosocial interventions can improve symptoms in individuals with ASD, suggesting potential success for this approach in similar populations.

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.

Where this trial is running

Rome

• 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

Conditions Fragile X Syndrome; Autism Spectrum Disorder; intellectual disability; adaptive functioning; quality of life; rare genetic syndrome; Cognitive Behavioral Therapy; CBT