Viewing Study NCT06418035



Ignite Creation Date: 2024-05-19 @ 5:34 PM
Last Modification Date: 2024-10-26 @ 3:29 PM
Study NCT ID: NCT06418035
Status: RECRUITING
Last Update Posted: 2024-05-16
First Post: 2024-05-02

Brief Title: Acquisition of Daily Living Skills in Autistic Children Comparison Between QR Code and a Human Operator
Sponsor: Istituto per la Ricerca e lInnovazione Biomedica
Organization: Istituto per la Ricerca e lInnovazione Biomedica

Study Overview

Official Title: Acquisition of Daily Living Skills in Autistic Children Comparison Between Video-modeling Mediated by iPad QR Code and Modeling With a Human Operator
Status: RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Autism spectrum disorder ASD is a condition characterized by deficits in social communication and mutual interaction as well as repetitive and restricted behaviors and interests This condition manifests itself differently in each individual and can vary greatly in severity and impact on daily life

Autistic children may present various challenges and difficulties in developing daily living skills DLS These difficulties may relate to various areas such as personal autonomy and domestic autonomy For example they may have difficulties in acquiring personal hygiene skills such as dressing and tying their shoes independently They may have difficulty performing household tasks such as setting the table preparing a simple meal or folding a t-shirt These difficulties may require specific support and training to help autistic children develop personal autonomy skills and achieve greater independence in different areas of their daily lives Improving and developing DLS is an important goal in order to improve the quality of life and independence of children with autistic conditions

This protocol aims to acquire new useful DLS within the various settings of daily life The hypothesis of the present study is the following video modeling through the use of the iPad Qr code scanning can be more effective in promoting autonomy in children with ASD compared to a control group that receives a traditional training without the use of technological instrumentation
Detailed Description: In this study participants will be randomly assigned to an experimental or control group

Both groups will be subjected to applied behavior analysis ABA procedures the behavioral procedure called modeling is a technique in which the participant observes and imitates a target behavior of a operator who serves as a model Such modeling can be in vivo or remotely via video

Also included is the use of task analysis with the aim of identifying all the smaller teachable units of a complex behavior the sub-targets that make up a behavioral chain The participant after observing the entire target task performed by the model in turn performs the behavioral chain

Based on the data collected at baseline the operator will deliver a simultaneous response prompt to promote errorless learning only in the individual subtasks absent in the participants repertoire The mode in which prompts will be delivered will be of the least to most type that is from least to most intrusive help according to the following hierarchy

P1 gestural prompt P2 verbal-vocal prompt P3 total physical prompt The operator will begin by delivering the least intrusive prompt P1 gestural If the participant does not deliver the correct behavior within 5 the operator will move to the next most intrusive prompt P2 verbal-vocal if the participant does not deliver the correct behavior within 5 the operator will move to the next most intrusive prompt P3 total physical

Both groups will be subjected to n 5 personal autonomies during every experimental sessions

The experimental group inside the HomeLab will scan the Qr code using iPad and view the video-modeling of the target activity to be performed the control group will carry out the target activity inside the HomeLab in a traditional way without technological instrumentation and will observe the operator who acts as a model live

This experimental study will be implemented for a total of 6 months with biweekly frequency lasting 45 minutes per session At the end of each session the percentage of independent correct answers will be calculated The acquisition criterion for defining acquired target autonomy is the achievement of 90 independent responses for 3 consecutive sessions

Families of children with ASD will be recruited from the Institute for Biomedical Research and Innovation of the Italian National Research Council IRIB-CNR in Messina Italy

Eligible participants who meet the inclusion criteria will receive written information about the procedure and will be asked to sign the informed consent form indicating their willingness to participate in the study Only those individuals who have provided informed consent will be randomly assigned to the experimental or control group

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None