Applied Behavior Analysis With Technologies

Evaluating the Effect of Use of Technologies to Increase the Cognitive Abilities in Children With Autism Spectrum Disorders

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Autism
• Intervention / Treatment: Behavioral: Applied Behavior Analysis protocol; Behavioral: Traditional intervention

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Flavia Marino; Phone Number: +393395798263; Email: flavia.marino@irib.cnr.it
• Study Contact Backup: Name: Maria Valeria Maiorana; Phone Number: +393285856656; Email: mvaleriamaiorana@gmail.com

Study Locations

• Italy
  • Messina, Italy, 98164
    • Recruiting
    • Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
    • Contact: Flavia Marino; Phone Number: +393395798263; Email: flavia.marino@irib.cnr.it
    • Principal Investigator: Flavia Marino
    • Sub-Investigator: Giovanni Pioggia
    • Sub-Investigator: Paola Chilà
    • Sub-Investigator: Roberta Minutoli
    • Sub-Investigator: Noemi Vetrano
    • Sub-Investigator: Chiara Failla
    • Sub-Investigator: Germana Doria
    • Sub-Investigator: Ileana Scarcella
    • Contact: Maria Valeria Maiorana; Phone Number: +393285856656; Email: mariavaleria.maiorana@irib.cnr.it
    • Sub-Investigator: Cinzia Grasso
    • Sub-Investigator: Mariaelena Franchina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children with diagnosis of autism

Exclusion Criteria:

• presence of other medical disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; 15 children belonging to the experimental group will undergo the treatment carries out the procedure by means of stimuli presented with technologies supports	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.
Other: control group; 15 children belonging to the control group will undergo the treatment by performing the procedure with images printed on laminated A4 sheets.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
• Investigators: Principal Investigator: Flavia Marino, Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: children; autism spectrum disorder; Autism; Applied Behavior Analysis; ABA
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: CNR-IRIB-PRO-2024-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No