Clinical trial NCT06418035: Acquisition of Daily Living Skills in Autistic Children: Comparison Between QR Code and a Human Operator
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Keywords: autism
children
technology
daily living skills
video modeling
applied behavior analysis
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
Collaborators: name: Messina, Italy
First posted: 2024-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 participant's 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of autism spectrum disorder;
* IQ below 80 assessed by means of WISC IV or Leiter-3;
* Passing the ABLLS-R "imitation" and "visual performance" tests

Exclusion Criteria:

* Presence of other medical disorders;
* Absence of imitative and visual-perceptual skills.

Primary outcomes:
measure: WISC-IV (Wechsler Intelligence Scale for Children-4° edition)
timeFrame: The evaluation session will be scheduled pre-intervention (T0). The test needs approximately 65-80 minutes to complete.
measure: Griffiths Mental Development Scales (GMDS-3rd)
timeFrame: The evaluation session will be scheduled pre-intervention (T0). Test administration is individual and lasts about 90 minutes.
measure: Vineland Adaptive Behavior Scales-II (Vineland-II)
timeFrame: The tests will be scheduled pre intervention (T0) and at the study conclusion, at 6 months (T1).The T0 and T1 evaluations were conducted to determine whether the protocol carried out made a change. The test needs about 60 minutes.
measure: The Assessment of Basic Language and Learning Skills-Revised (ABLLS-R)
timeFrame: The tests will be scheduled pre intervention (T0) and at the study conclusion, at 6 months (T1). The administration time is approximately 60 minutes.
measure: Psychoeducational profile-3 (Pep-3)
timeFrame: The questionnaire will be scheduled pre intervention (T0) and at the study conclusion, at 6 months (T1). The administration time of the questionnaire for parents is 45 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Study officials:
affiliation: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
name: Flavia Marino
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mclay, Laurie & Carnett, Amarie & van der Meer, Larah & Lang, Russell. (2015). Using a Video Modeling-Based Intervention Package to Toilet Train Two Children with Autism. Journal of Developmental and Physical Disabilities. 27. 10.1007/s10882-015-9426-4.
citation: Drysdale, Bradley & Lee, Clara & Anderson, Angelika & Moore, Dennis. (2014). Using Video Modeling Incorporating Animation to Teach Toileting to Two Children with Autism Spectrum Disorder. Journal of Developmental and Physical Disabilities. 27. 10.1007/s10882-014-9405-1.
citation: Popple B, Wall C, Flink L, Powell K, Discepolo K, Keck D, Mademtzi M, Volkmar F, Shic F. Brief Report: Remotely Delivered Video Modeling for Improving Oral Hygiene in Children with ASD: A Pilot Study. J Autism Dev Disord. 2016 Aug;46(8):2791-2796. doi: 10.1007/s10803-016-2795-4.
citation: Lee, Clara & Anderson, Angelika & Moore, Dennis. (2014). Using Video Modeling to Toilet Train a Child with Autism. Journal of Developmental and Physical Disabilities. 26. 10.1007/s10882-013-9348-y.