- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02233348
Neurocognitive and Psychosocial Outcome of Youths With Autism Spectrum Disorder
Neurocognitive and Psychosocial Outcome of Youths With Autism Spectrum Disorder: a Follow-up Study
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Primary Aim:
To investigate the neuropsychological, neuroimaging, social cognitive, and psychosocial outcomes at adolescence and young adulthood among children with ASD as compared to typically developing (TD) controls.
Secondary Aims:
- To examine the changes and stability of ASD core symptoms, neuropsychological function, structured and functional connectivity, psychosocial functions over a 4-7 year follow-up period.
- To identify early individual (clinical, behavioral, and neurocognitive variables), family, school, environmental factors to predict the neurocognitive and psychosocial outcomes at adolescence and young adulthood.
- To validate the neuropsychological functioning (e.g., set-shifting, executive function, and visuo-spatial memory etc.) and structural (morphometric,, cortical thickness, gyrification, white matter tract integrity) and functional connectivity (resting-state and social task fMRI) in fronto-temporal, cortico-striato-thalamic, default mode network, and other circuits as effective imaging endophenotypes (biomarkers) by demonstrating the stability of these imaging data and the intermediate position of unaffected siblings between ASD probands and age-, sex-, handedness-, and IQ-matched TD at Time 1 and follow-up.
- To correlate the data from structural and functional connectivity, neuropsychology and ASD core symptoms stratifying by proband-unaffected sibling dyads, and different developmental stages.
- To collect blood sample, and to analyze neurodevelopmental and immune genes, cytokine level, and environmental exposure.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Taipei, Taïwan
- National Taiwan Univeristy Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
ASD participants
- that they have a clinical diagnosis of autistic disorder or Asperger disorder defined by the DSM-IV and ICD-10 criteria, made by board-certificated child psychiatrists and who were clinically diagnosed with ASD confirmed by the ADI-R 7 years ago;
- their ages range from 10 to 25 (i.e., 3-18 years old at the first assessment);
- both parents are Han Chinese;
- who have complete clinical and behavioral data at the 1st assessment;
- participants and their parents consented to participate in this longitudinal study 7 years ago for complete assessments (3 visits of assessments) at follow-up.
Inclusion Criteria for TD controls, who will be recruited either by school teachers or from the community, are that they are Han Chinese, consent to the study (if age <18, parents, too) to complete all the assessments.
Exclusion Criteria:
For TD controls:
- comorbidity with DSM-IV-TR or DSM-5 diagnoses of ASD, ADHD, schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorder, organic psychosis, schizotypal personality disorder, bipolar disorder, depression, severe anxiety disorders or substance use;
- comorbidity with neurological or systemic disorders; and
- having a first degree relative who may have ASD based on family history method assessment.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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ASD group
Subjects with DSM-IV ASD diagnosis
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Control group
Controls without lifetime ASD or a family history of ASD
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Diagnosis of autism
Délai: one day
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Using Autism Diagnostic Interview-Revised (ADI-R) to assess the developmental and behavioral aspects of autism, including reciprocal social interaction, communication, and repetitive behaviors and stereotyped patterns.
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one day
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Diagnosis of autism
Délai: one day
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Using Autism Diagnostic Observation Scale (ADOS) to assess social communication, social relatedness, play, imaginative of materials, and restricted and/or repetitive behaviors.
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one day
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 201403109RINC
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