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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06310317
Other study ID # CNR-IRIB-PRO-2024-003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date January 31, 2025

Study information

Verified date March 2024
Source Istituto per la Ricerca e l'Innovazione Biomedica
Contact Flavia Marino
Phone +393395798263
Email flavia.marino@irib.cnr.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Applied Behavior Analysis (ABA) is a therapeutic approach for autism that is based on the principles of behavioral theory, learning, and positive reinforcement. Current research shows that early and intensive ABA intervention is effective in reducing dysfunctional behaviors and promoting learning and enactment of socially appropriate behaviors. In this context, new approaches that attempt to integrate advanced technologies can play a key role. This experimental protocol aims to test whether the use of advanced technologies, such as tablets, as part of an intervention for a group of children with autism spectrum disorder (ASD) is more effective than the traditional approach implemented in a control group of children with ASD. The experimental protocol is aimed at enhancing cognitive skills, increasing new skills and acquiring functional/adaptive behaviors.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date January 31, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers No
Gender All
Age group 5 Years to 12 Years
Eligibility Inclusion Criteria: - Children with diagnosis of autism Exclusion Criteria: - presence of other medical disorders

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Applied Behavior Analysis protocol
The main objective of the experimental protocol is to promote the development of cognitive skills, facilitate the acquisition of new skills and promote the adoption of functional and adaptive behaviors. The use of Applied Behavior Analysis procedures, with the help of technological tools such as a tablet or robot can facilitate the increase of new knowledge and skills. The criterion is acquired if the subject emits 8 out of 10 independent correct responses (90%) for 3 consecutive sessions. The objective is to test whether the technological tool used (tablet or robot) can make the proposed learning procedure more effective. The experimental group carries out the procedure by means of stimuli presented on tablets or robots.
Traditional intervention
The main objective of the experimental protocol is to promote the development of cognitive skills, facilitate the acquisition of new skills and promote the adoption of functional and adaptive behaviors. In this group the materials are traditional, such as image printed. The criterion is acquired if the subject emits 9 out of 10 independent correct responses (90%) for 3 consecutive sessions. The control group performs the procedure with images printed on A4 laminated sheets.

Locations

Country Name City State
Italy Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) Messina

Sponsors (1)

Lead Sponsor Collaborator
Istituto per la Ricerca e l'Innovazione Biomedica

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Choi KR, Bhakta B, Knight EA, Becerra-Culqui TA, Gahre TL, Zima B, Coleman KJ. Patient Outcomes After Applied Behavior Analysis for Autism Spectrum Disorder. J Dev Behav Pediatr. 2022 Jan 1;43(1):9-16. doi: 10.1097/DBP.0000000000000995. — View Citation

Valencia K, Rusu C, Quinones D, Jamet E. The Impact of Technology on People with Autism Spectrum Disorder: A Systematic Literature Review. Sensors (Basel). 2019 Oct 16;19(20):4485. doi: 10.3390/s19204485. — View Citation

Yu Q, Li E, Li L, Liang W. Efficacy of Interventions Based on Applied Behavior Analysis for Autism Spectrum Disorder: A Meta-Analysis. Psychiatry Investig. 2020 May;17(5):432-443. doi: 10.30773/pi.2019.0229. Epub 2020 May 8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) Is an assessment tool that attends to all those skills that are fundamental to the development and enhancement of verbal communication skills and the proper use of language in social interactions. It focuses especially on the assessment of language prerequisites fundamental to the development of verbal behavior in accordance with the classification of verbal operants proposed by Skinner: mand, tact, echoic, intraverbal. It consists of a manual, a protocol and a set of materials (pictures and standardized items for assessment). The protocol is divided into:
Tables
Early Echoic Skills Assessment (EESA) - Assessment of barriers: behaviors that might hinder the child's learning
Assessment of transitions: the child's ability to make the transition to teaching modes based on the natural context
Task Analysis and Skills Monitoring: describes the individual milestones required to reach the main milestone
Scoring grids
the test need approximately 1 hour
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