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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05666934
• Other study ID #: B-BR-107-066
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: December 2022
• Source: National Cheng Kung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 41 Months to 70 Months

Eligibility

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).

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Device:
• Augmented Reality Storybook
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.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng Kung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vineland Adaptive Behavior Scales-Third Edition	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
Primary	Functional Emotional Assessment Scale	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