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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Clinical diagnosis of Fragile X Syndrome confirmed by genetic testing or Autism Spectrum Disorder confirmed by ADOS-2 and ADI-R interviews
Age between 13 and 19 years
Verbal language skills compatible with group intervention (sentence level)
Impairment in adaptive functioning measured by Vineland Adaptive Behavior Scales II (VABS II) less than 70
Informed consent for participation and data processing provided by parents
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 as measured by Autism Behavior Checklist (ABC) Irritability Scale less than 18
IQ less than 40 measured by Leiter third edition
Severe adaptive functioning impairment measured by VABS II less than 20
Identification of specific genetic abnormalities or syndromes associated with Autism Spectrum Disorder (e.g., TSC, FXS, 22q11, 16p11.2, Rett Syndrome) for ASD group only (not FXS group)
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants receive Cooperative Group Therapy (CGT), a cognitive-behavioral group therapy consisting of 15 sessions over 6 months, including 12 group sessions with adolescents and 3 sessions involving their parents. Each session lasts 90 to 120 minutes and focuses on improving pragmatic, executive, and cooperative interaction skills.
15 sessions over 6 months
Follow-up
Duration - Up to 6 months after treatment
Participants are monitored after treatment to assess clinical outcomes and maintenance of treatment benefits through standardized questionnaires and evaluations.
Assessments at treatment end and follow-up visits
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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Published Research Related To This Trial
Cooperative Parent-Mediated Therapy in Children with Fragile X Syndrome and Williams Beuren Syndrome: A Pilot RCT Study of a Transdiagnostic Intervention-Preliminary Data.
Paolo Alfieri, Francesco Scibelli, Laura Casula...