NCT06418035

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.

Trial Health

57
Monitor

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 Oct 2023

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

9 months

First QC Date

May 2, 2024

Last Update Submit

May 13, 2024

Conditions

Keywords

autismchildrentechnologydaily living skillsvideo modelingapplied behavior analysis

Outcome Measures

Primary Outcomes (5)

  • WISC-IV (Wechsler Intelligence Scale for Children-4° edition)

    Wechsler Intelligence Scale for Children Fourth edition (WISC-IV) is a clinical tool for assessing the cognitive abilities of children and young people between the ages of 6 years and 16 years and 11 months. The WISC-IV scales are as follows: index of verbal comprehension (ICV), range weighted scores (min 46 - max154); index visuoperceptual reasoning (IRP), range weighted scores (min 41- max 159); index working memory (IML) range weighted scores (min 46 - max 154); processing speed index (IVE) range weighted scores (min 47 - max 153); intelligence quotient IQ (min 40 - max 160). For each sub-scale higher score corresponds to better performance.

    The evaluation session will be scheduled pre-intervention (T0). The test needs approximately 65-80 minutes to complete.

  • Griffiths Mental Development Scales (GMDS-3rd)

    The Griffiths III are an instrument for assessing child development from birth to 6 years of age. The Griffiths III are based on an integrated model of development, conceived as consisting of various domains that interact and influence each other and determine the child's development. Scale A. Basics of learning, range scores (min 0 - max 20) Scale B. Language and communication, range scores (min 0 - max 20). Scale C. Oculo-manual coordination, range scores (min 0 - max 20) Scale D. Personal-social-emotional, range scores (min 0 - max 20) Scale E. Gross-motor, range scores (min 0 - max 20) For each sub-scale higher score corresponds to better performance. The Griffiths III enables information to be obtained about each area of development considered (each scale can also be used individually), to draw a developmental profile in terms of strengths and weaknesses, but also to have an indication of the child's overall level of development.

    The evaluation session will be scheduled pre-intervention (T0). Test administration is individual and lasts about 90 minutes.

  • Vineland Adaptive Behavior Scales-II (Vineland-II)

    The Vineland-II, a revision of the Vineland Adaptive Behavior Scales, assess adaptive behavior (AB), i.e., the activities that the individual habitually performs to meet the expectations of personal autonomy and social responsibility characteristic of people of the same age and cultural background. Specifically, they aim to measure AB in the domains Communication, range scores (min 0 -max 160), Skills of Daily Living, range scores (min 0 - max 160) Socialization, range scores (min 0- max 160) (in individuals from 0 to 90 years of age) and Motor Skills, range scores (min 0 -max 160) (in individuals from 0 to 7 years of age and 56 to 90 years of age). For each sub-scale higher score corresponds to better performance. Assessment of AB is necessary for diagnosis of intellectual disability disorder and, in accordance with DSM-5, for assessment of the level of severity of the disorder. The Vineland-IIs consist of 4 scales divided into 11 subscales. They also provide an overall AB index.

    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.

  • The Assessment of Basic Language and Learning Skills-Revised (ABLLS-R)

    The Assessment of Basic Language and Learning Skills- Revised (ABLLS-R) is tracking system based on the basic language and functional skills of an individual with autism and other developmental delays. It is used as a tool to help develop individualized curricula to teach language and other critical skills to children with autism or other developmental disabilities. The ABLLS-R focuses on 25 skills in the areas of language, social interaction, self-help, academic and motor skills. The evaluation of this tool helps to identify the skills necessary for the child to communicate effectively and to identify obstacles that prevent the child from acquiring new skills. For research purposes, the evaluation will focus on self-help skills, specifically: Dressing Skills (min 0 - max 30), Feeding-related autonomies ( min 0 - max 20) Personal care skills ( min 0 - max 14), Toileting Skills ( min 0 max 20). For each sub-scale higher score corresponds to better performance.

    The tests will be scheduled pre intervention (T0) and at the study conclusion, at 6 months (T1). The administration time is approximately 60 minutes.

  • Psychoeducational profile-3 (Pep-3)

    PEP-3 assesses learning inhomogeneity, strengths and weaknesses, and related developmental disabilities in children with autism and pervasive developmental disorders and children with developmental difficulties that are difficult to test (age range 2 to 12 years). It is part of the TEACCH materials for individualized psychoeducational assessment and intervention for children with Autism Spectrum Disorder. The test consists of two main components: 1. The Performance section (10 subtests) 2. The questionnaire for parents (3 subtest). For the purpose of the research, only the parental questionnaire will be used. It investigates: problem behavior range scores (min 1 - max 20.) , personal autonomy range scores (min 1 - max 20.), adaptive behavior range scores (min 1 - max 20.). For each sub-scale higher score corresponds to better performance.

    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.

Study Arms (2)

Experimental group: treatment with technological tool

EXPERIMENTAL

The intervention will be structured according to Applied Behavioral Analysis. The target activities to be performed are shown on the iPad through video-modeling. The child, using iPad, scans QR codes placed in various stations of the HomeLab, near the place where the target autonomy will be carried out. HomeLab is a room that simulates a real apartment with various domestic areas and allows the child to feel as comfortable as at home.

Behavioral: Video modeling by scanning Qr code

Control group: traditional treatment without technological tool

OTHER

The intervention will be structured according to Applied Behavioral Analysis. The target activities to be performed within HomeLab are shown, live, by an operator who acts as a model.

Behavioral: Modeling traditional method

Interventions

The protocol activity carried out by the experimental group will involve the use of the QR Code: in the operator's presence, the child scans the code through a technological device and watches the video of the activity to be played later in the HomeLab.

Experimental group: treatment with technological tool

The control group will carry out the protocol activities in a traditional way, without technological tools. The child observes the operator who shows the live activity inside the HomeLab.

Control group: traditional treatment without technological tool

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

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 (4)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 27106570BACKGROUND
  • 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.

    BACKGROUND

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

May 2, 2024

First Posted

May 16, 2024

Study Start

October 1, 2023

Primary Completion

June 30, 2024

Study Completion

December 31, 2025

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations