Home-based Augmented Reality Storybook Training Modules for Children With Autism Spectrum Disorder

December 23, 2022 updated by: Ling-Yi Lin, National Cheng Kung University

Using Home-based Augmented Reality Storybook Training Modules for Facilitating Emotional Functioning and Socialization of Children With Autism Spectrum Disorder

Autism spectrum disorder (ASD) is a lifelong neurodevelopmental disability with increasing prevalence worldwide. The main difficulties include poor social interaction and self-regulation skills. Effective interventions are required to improve the social interaction skills and emotional regulation of children with ASD. The present study involved developing and testing the feasibility and short-term efficacy of the home-based augmented reality (AR) training modules for preschool children with ASD. We recruited 15 children with ASD (3 to 5 years old). Wilcoxon signed rank test analysis was used to compare the differences in emotional functioning and adaptive behavior. Children received 8-week home-based AR training modules. Sessions were 20 minutes 4 times a week.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Autism Spectrum Disorder (ASD) is a lifelong neurodevelopmental disability with increasing prevalence worldwide. Its symptoms include limitations in social interaction and repetitive and restrictive behaviors. These symptoms may result in difficulties in participating in daily life and social activities across the lifespan. The main challenges include poor communication, social interaction, and emotional regulation skills that can limit and impair a person's everyday functioning. Many parents of children with ASD had an increased caregiver burden. In addition, the total lifetime cost of autism per individual is about 3.6 million US dollars. Thus, there is an urgent need to develop appropriate and effective interventions for improving the communication and self-regulation skills of children with ASD. Research has increasingly focused on the effectiveness of interventions for children with ASD. Nonetheless, research has yet remained an underappreciated concept in different cultural contexts. To address these gaps, the present study involved developing and testing the feasibility and effectiveness of the home-based Augmented Reality (AR) social story training modules for preschool children with ASD. The home-based AR social story training modules are designed. We recruited 15 children with ASD (3 to 5 years old). Wilcoxon signed rank test analysis was used to compare the differences in emotional functioning and adaptive behavior. Children received 8-week home-based AR training modules. Sessions were 20 minutes 4 times a week.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tainan, Taiwan, 701
        • National Cheng Kung University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • The inclusion criteria were children who (1) had a disability identification for ASD, (2) were aged 3 to 5 years and 11 months, and (3) scores at or above 30 according to the CARS-2.

Exclusion Criteria:

  • The exclusion criteria were children (1) whose nonverbal intelligence quotient was below 85 and (2) who had comorbid diagnoses with attention deficit hyperactivity disorder (ADHD).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home-based Augmented Reality Storybook Training Module
The children were entirely involved in this intervention program at home, with 20 minutes each time, 4 times a week for 8 weeks. The caregiver was required to perform the interactive picture book specified by the AR home training modules. During the process, the caregivers could directly contact the researcher by telephone and instant messaging for solving problems that occur during the interaction. The researcher and the caregiver consistently met once every two weeks. On the day of the meeting, the caregiver needs to prepare at least ten minutes of interactive video to discuss with the researcher. The researcher not only provides suggestions for caregiver interaction skills based on the video, in order to facilitate the child's interaction. The interaction strategies were also revised according to the interaction ability and special behavior problems of individual children.
The AR system was developed using a Vuforia Engine Package for Unity (PTC Inc, San Diego, CA), which enabled to create an application for children to view a storybook in their own homes. The children and caregivers could view eight scenarios (receiving a praise, broken toys, waiting in line at the playground, getting a vaccination, waiting for watching a video, hitting someone in an accident, grabbing a toy, understanding another person's feelings) and learn strategies for emotional events reflected in the tablet (Figure 1). This AR application supports a tablet size of 10.4 inches and is equipped with a Samsung Galaxy Tab A7.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vineland Adaptive Behavior Scales-Third Edition
Time Frame: 8 weeks
The Vineland Adaptive Behavior Scales-Third Edition (VABS-3) comprises four domains, that is, communication, daily living skills, socialization and motor skills, for assessing adaptive functioning in children aged 3 to 12 years old. The raw score in each domain and total raw score are converted to an age-equivalent score. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The range for each subscale is from 20 to 140. The subscales are summed to compute a total score, ranging from 80 to 560. The higher the scores are, the better adaptive functioning the children achieve.
8 weeks
Functional Emotional Assessment Scale
Time Frame: 8 weeks
The Functional Emotional Assessment Scale (FEAS; Greenspan et al., 2001) is based on six functional developmental levels of the developmental individual-difference relationship-based model and divided into two parts that (1) examine the children's development and (2) assess the parenting skills. All parents in the study were asked to record their parent-child activities as 15-minute videos. All videos were coded using random numbers to hide the research information (e.g. groups and test time). Two videos (pre- and post-test) were reviewed for each child. Using the Chinese version of the Scoring Form translated by Liao et al. (2014; intraclass correlation coefficient = 0.85), each item of the FEAS was rated as 0, 1 or 2. Higher raw scores represent better functions and skills. The total score is summed and ranges from 0 to 80.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ling-Yi Lin, ScD, National Cheng-Kung University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

July 31, 2022

Study Registration Dates

First Submitted

December 18, 2022

First Submitted That Met QC Criteria

December 23, 2022

First Posted (Actual)

December 28, 2022

Study Record Updates

Last Update Posted (Actual)

December 28, 2022

Last Update Submitted That Met QC Criteria

December 23, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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