Actively Recruiting

Phase Not Applicable
Age: 13Years - 19Years
All Genders
NCT06677866

Group CBT in Adolescents With Fragile X Syndrome and in Adolescents With Autism Spectrum Disorder

Led by Bambino Gesù Hospital and Research Institute · Updated on 2024-11-08

20

Participants Needed

1

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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. Many individuals with FXS exhibit symptoms overlapping with those of ASD, including difficulties in social-communication skills, challenges in peer relationships, restricted and repetitive behaviors/interests and deficits in adaptive functioning. Both in ASD and FXS, individuals with greater deficits in executive functions, socio-pragmatic, and socio-relational skills also demonstrate lower adaptive functioning and, consequently, reduced autonomy/independence throughout the life course and greater severity of the disorder. Among empirically validated treatments recommended by National and International Guidelines for the treatment of ASD, cognitive-behavioral and psychosocial interventions have been shown to improve some aspects of ASD, such as core symptoms, emotional-behavioral disturbances, adaptive skills, and quality of life. Currently, it appears that cognitive-behavioral therapies, which include psychoeducation programs, are particularly appropriate for ASD, with greater efficacy for group interventions compared to individual ones. Regarding FXS, despite the well-established knowledge of the cognitive-behavioral phenotype and the clear need for scientifically validated programs, research on intervention strategies remains quite limited. Considering the similarities between ASD and FXS and the need for standardized interventions, the present research project aims to conduct an RCT to evaluate the feasibility of Cooperative Group Therapy (CGT) in two different groups of adolescents with ASD and FXS. The decision to target the intervention to adolescents is due to the few clinical studies on this age group, which is a crucial target since, in FXS, there is often a plateau or reversal of intellectual and adaptive development after the age of 10, and in adolescents with ASD, the development and complexity of social, pragmatic skills, and executive functions are crucial for good adaptive functioning and a basic quality of life. Te main hypothesis is that CGT could contribute to the reduction of severity illness and in the enhancement of socio-communicative skills.

CONDITIONS

Official Title

Group CBT in Adolescents With Fragile X Syndrome and in Adolescents With Autism Spectrum Disorder

Who Can Participate

Age: 13Years - 19Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of Fragile X Syndrome confirmed by genetic testing (for FXS group)
  • Clinical diagnosis of Autism Spectrum Disorder confirmed by ADOS-2 and ADI-R interviews (for ASD group)
  • Age between 13 and 19 years
  • Verbal language skills compatible with group intervention (sentence level)
  • Impairment in adaptive functioning measured by VABS II score less than 70
  • Informed consent for participation and data processing provided by parents
Not Eligible

You will not qualify if you...

  • Severe visual or hearing impairments
  • Diagnosis of epilepsy or history of seizures requiring medication
  • Participation in other non-pharmacological treatments
  • Changes in pharmacological therapy within the last 3 months
  • Medical problems or behaviors interfering with group activities, indicated by Autism Behavior Checklist (ABC) Irritability Scale score less than 18
  • IQ less than 40 measured by Leiter third edition (Leiter 3)
  • Severe adaptive functioning impairment, measured by VABS II score less than 20
  • Identification of specific genetic abnormalities or known genetic syndromes associated with ASD (e.g., TSC, FXS, 22q11, 16p11.2, Rett Syndrome) for ASD group only

AI-Screening

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Trial Site Locations

Total: 1 location

1

Bambino Gesù Children's Hospital

Rome, Italy, 00165

Actively Recruiting

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Research Team

A

Alice Federica M Montanaro, PsyD

CONTACT

P

Paolo Alfieri, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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