- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02235467
Multisite Study: Parental Training Using Video Modelling to Develop Social Skills in Children With Autism
Multisite Study: Acquisition of Social Skills in Children With Autism Using Video Modeling in Parental Training
This is a Brazilian multisite study to test the efficacy of an Applied Behavior Analysis (ABA) parent training using video modeling to teach parents of children with Autism techniques to apply to their children in order to improve eye contact and joint attention behaviors.
Our hypothesis is that children with Autism whose parents will be trained by videomodeling will have better eye contact and joint attention behaviors compared to children with Autism whose parents will not be trained.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Applied Behavior Analysis (ABA) is an intervention with proven efficacy in treating impairments on social functioning and daily-life activities of individuals with Autism Spectrum Disorder (ASD). In Brazil we have a limited number of qualified professionals and an increasing demand of families non-served in the public health system.
Our main objective is to standardize and test the efficacy of a model for parent training using video modeling for teaching eye contact and joint attention behaviors in children with ASD. These two behaviors are essential to develop adequate social interaction, the core impaired domain in ASD. It is a multisite study to be carried out at the Universidade Federal de São Paulo, Universidade de São Paulo and Universidade Presbiteriana Mackenzie. The sample will be composed of 70 children divided in control and intervention groups that will be randomly chosen. The intervention should be carried out in 21 weeks.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
-
São Paulo, Brésil, 04038-030
- Federal University of São Paulo Department of Psychiatry
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Clinical Diagnosis of Autism Spectrum Disorders
- Diagnosis of Autism Spectrum Disorders by means of ADI
- IQ equal or lower than 70 by means of SON
- Main caregiver's level of education > primary education
Exclusion Criteria:
- IQ lower than 50 by means of SON
- Child who is receiving ABA therapy at least 10 hours per week
- Main caregiver diagnosed with Autism Spectrum Disorders
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: ABA parent training
Applied Behavior Analysis parent training using videomodeling in 21 sessions
|
A parent training based on Applied Behavior Analysis that is going to be delivered by video modeling in 21 weeks
Autres noms:
|
|
Aucune intervention: ABA parent training control
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Acquisition from baseline of new behaviors at 8 weeks
Délai: baseline assessment to 8 weeks of therapy
|
acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
|
baseline assessment to 8 weeks of therapy
|
|
Acquisition from baseline of new behaviors at 16 weeks
Délai: baseline assessment to 16 weeks
|
acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
|
baseline assessment to 16 weeks
|
|
Acquisition from baseline of new behaviors at 21 weeks
Délai: baseline to 21 weeks
|
acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
|
baseline to 21 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from baseline in Eye-tracking at 21 weeks
Délai: baseline assessment to 21 weeks
|
Latency, duration, and sequence of visual fixations measured with eye-tracking
|
baseline assessment to 21 weeks
|
|
Change from baseline in Vineland Scale at 21 weeks
Délai: baseline assessment to 21 weeks
|
Adaptative behavior using Vineland Scale
|
baseline assessment to 21 weeks
|
|
Change from baseline in SON-R 2½-7 at 21 weeks
Délai: baseline assessment to 21 weeks
|
Improve on SON-R 2½-7 that is an intelligence coefficient test developed for deaf people
|
baseline assessment to 21 weeks
|
|
Change from baseline in Zaritt Burden Interview at 21 weeks
Délai: baseline assessment to 21 weeks
|
The Zaritt Burden Interview measures the caregiver burden of taking care of the relative with psychiatric disorder
|
baseline assessment to 21 weeks
|
|
Change from baseline in OERA at 21 weeks
Délai: baseline assessment to 21 weeks
|
OERA (Observação Estruturada para Rastreamento de Autismo) is a taped structured observation to screen Autism that was developed by Brazilian researchers.
|
baseline assessment to 21 weeks
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from baseline in KAP at 21 weeks
Délai: baseline assessment to 21 weeks
|
Improvement on the knowledge, attitude and practice (KAP) questionnaire
|
baseline assessment to 21 weeks
|
|
Change from baseline in Hamilton scalels and at 21 weeks
Délai: baseline assessment to 21 weeks
|
Improvement on the Hamilton Depression and Anxiety scales of the caregiver
|
baseline assessment to 21 weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Sheila C Caetano, MD, PhD, Federal University of São Paulo, São Paulo, Brazil
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
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
- U1111-1157-8984
- 2012/51584-0 (Autre subvention/numéro de financement: FAPESP)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .