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

Summary

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

• Fragile X Syndrome (FXS)
• Autism Spectrum Disorder

Interventions

BEHAVIORAL

Cognitive behavioral therapy

Cooperative Group Therapy (CGT) is a cognitive-behavioral group therapy based on the theoretical and practical principles of the Cooperative Parent-Mediated Therapy model \[Valeri et al., 2020\]. The goal of CGT is to promote the following core skills: Pragmatics, Executive Functions, and Cooperative Interactions. The CGT program consists of 15 sessions over a total duration of 6 months: 12 group therapy sessions with adolescents and 3 sessions with their parents. Each session focuses on a specific topic and lasts between 90 and 120 minutes. The CGT therapist is a psychotherapist with a cognitive-behavioral orientation who utilizes evidence.-based strategies to enhance pragmatic, socio-conversational skills, cognitive flexibility, emotional regulation, and cooperative interactions. The CGT intervention is conducted by two cognitive-behavioral psychotherapists specialized respectively in the treatment of FXS and ASD.

OTHER

Waiting List

The Waiting List (WL) is a control group in which participants who do not receive the experimental treatment are placed on a waiting list to receive the intervention after the active treatment group has completed it. In the case of the WL, the CGT intervention is carried out after at least 6 months to allow the patients in the first group to complete the treatment cycle. This approach enables a comparison between a group of treated patients and a group of patients who have not yet been treated, while still allowing the latter to access the treatment at a later stage.

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute

  lead OTHER

Principal Investigators

• Paolo Alfieri, MD, PhD · Bambino Gesù Children's Hospital

• Stefano Vicari, MD, clinical professor · Bambino Gesù Hospital and Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-01

Primary Completion

2024-09-15

Completion

2025-12-31

Countries

• Italy

Study Locations