NCT06310317

Brief 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

March 7, 2024

Last Update Submit

March 7, 2024

Conditions

Keywords

Autismautism spectrum disorderchildrenApplied Behavior AnalysisABA

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

OTHER

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

Interventions

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.

experimental group

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.

control group

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with diagnosis of autism

You may not qualify if:

  • presence of other medical disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Messina, 98164, Italy

RECRUITING

Related 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.

    PMID: 34342287BACKGROUND
  • 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.

    PMID: 32375461BACKGROUND
  • 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.

    PMID: 31623200BACKGROUND

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Flavia Marino

    Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Unit

Study Record Dates

First Submitted

March 7, 2024

First Posted

March 15, 2024

Study Start

September 1, 2023

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations