Frajil X Sendromu ve Otizm Spektrum Bozukluğu Olan Ergenlerde Grup BDT

Sade dilde özet

Bu çalışma, Frajil X sendromu (Fragile X syndrome) ve otizm spektrum bozukluğu (autism spectrum disorder) olan ergenlerde grup bilişsel davranışçı terapinin (cognitive behavioral therapy) etkisini incelemektedir. Genetik testle Frajil X sendromu tanısı doğrulanmış ya da ADOS-2 ve ADI-R ile otizm tanısı konmuş, 13-19 yaş arası, grup çalışmasına uygun dil becerisine sahip ergenler dahil edilebilmektedir. Çalışma faz uygulanmayan bir çalışma olup halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz dışı

Durum

Katılımcı alıyor

Sponsor

Bambino Gesù Hospital and Research Institute

Müdahale

Cognitive behavioral therapy, Waiting List

Başlangıç

01.09.2022

Tahmini bitiş

31.12.2025

Ülkeler

Italy

İlgili genler

Merkezler

• Rome, Italy

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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.