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Age: 13Years - 19Years
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ID06677866

Testing Cooperative Group Therapy to Improve Social and Adaptive Skills in Adolescents Aged 13 to 19 With Fragile X Syndrome or Autism Spectrum Disorder

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

20

Participants Needed

1

Research Sites

67 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the effectiveness and feasibility of Cooperative Group Therapy CGT, a cognitive-behavioral group intervention, in adolescents with Fragile X Syndrome FXS and Autism Spectrum Disorder ASD. Both conditions share overlapping symptoms such as social-communication difficulties, repetitive behaviors, and challenges in adaptive functioning. Adolescents are targeted because this age is critical for social and cognitive development, and in FXS, intellectual and adaptive skills may plateau or decline after age 10. The study focuses on reducing the severity of the disorder and improving socio-communicative skills through a randomized controlled trial RCT. Participants will be assigned to groups receiving CGT either immediately or after a waiting period. The CGT program includes 15 sessions over six months 12 group therapy sessions for adolescents and 3 parent sessions. Sessions last 90 to 120 minutes and focus on enhancing pragmatic communication, executive functions, and cooperative interactions. The therapy is delivered by specialized cognitive-behavioral psychotherapists experienced with FXS and ASD. Waiting list groups serve as controls, receiving the intervention after six months. During the study, participants undergo assessments before and after treatment, including cognitive and adaptive evaluations and standardized questionnaires measuring autism symptoms, executive function, anxiety, behavior, quality of life, and parental stress. The primary outcome is the change in severity measured by the Global Clinical Impression - Severity Scale after six months. Secondary outcomes include improvements in behavior, adaptive skills, anxiety, and quality of life. The total participation period includes treatment and follow-up assessments to monitor progress and safety.

CONDITIONS

Brief Title

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

Research Team

A

Alice Federica M Montanaro, PsyD

P

Paolo Alfieri, MD, PhD

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