AVATA Cure Digital Therapeutics for Social Communication in Children With Autism Spectrum Disorder: A Pilot Clinical Trial

Article information

Psychiatry Investig. 2026;23(4):510-519
Publication date (electronic) : 2026 April 6
doi : https://doi.org/10.30773/pi.2025.0354
1Department of Psychiatry, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea
2Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea
3Department of Medicine, CHA University, Seongnam, Republic of Korea
4Division of Speech-Language Pathology, Gachon University, Seongnam, Republic of Korea
5Department of Counseling & Therapy, Gachon University, Seongnam, Republic of Korea
6PlaytoCure Co., Ltd., Seongnam, Republic of Korea
7Department of Linguistics, Seoul National University, Seoul, Republic of Korea
8Grib Inc., Seoul, Republic of Korea
Correspondence: Hyun-Ju Kim, MD, PhD Department of Psychiatry, CHA Bundang Medical Center, CHA University School of Medicine, 59 Yatap-ro, Bundang-gu, Seongnam 13496, Republic of Korea Tel: +82-31-780-2996, Fax: +82-31-780-5862, E-mail: hyunju3141@cha.ac.kr
Correspondence: Tai Kiu Choi, MD, PhD Department of Psychiatry, CHA Bundang Medical Center, CHA University School of Medicine, 59 Yatap-ro, Bundang-gu, Seongnam 13496, Republic of Korea Tel: +82-31-780-5943, Fax: +82-31-780-5862, E-mail: aa3607@chamc.co.kr
Received 2025 October 11; Revised 2026 January 7; Accepted 2026 January 20.

Abstract

Objective

Autism spectrum disorder (ASD) is characterized by deficits in social interactions, reciprocal communication, and pragmatic language. Traditional therapeutics are effective but limited by economic, temporal, and spatial constraints. This pilot trial evaluated the effectiveness of AVATA Cure, a mobile-based digital therapeutic application, in improving the social communication skills of children with ASD.

Methods

Thirty-three children with ASD aged 1–7 years were enrolled, of whom 29 completed the study. Participants used AVATA Cure at home on a tablet device for at least 30 minutes per day, 4 days per week, for 8 weeks. The program included modules targeting joint attention, receptive and expressive pragmatics, and non-verbal communication. Social communication skills were assessed at baseline, 4 weeks, and 8 weeks using the Autism Diagnostic Observation Schedule-2 (ADOS-2); Sequenced Language Scale for Infants (SELSI) or Preschool Receptive-Expressive Language Scale (PRES); Social Communication Questionnaire (SCQ); and Korean Vineland Adaptive Behavior Scales 2nd edition (K-Vineland-II). The statistical analyses included complete case analysis with analysis of variance and Bonferroni correction.

Results

Significant improvements were observed in all measures. ADOS-2 reciprocal social interaction scores decreased significantly, indicating reduced impairment. SELSI/PRES pragmatic language scores increased significantly. SCQ scores decreased, and the K-Vineland-II subscales improved, reflecting enhanced adaptive functioning.

Conclusion

AVATA Cure demonstrated preliminary efficacy for enhancing social communication among children with ASD. Notable improvements across multiple assessments suggest its potential as a scalable, accessible, and cost-effective intervention that may complement existing therapies and provide early therapeutic benefits.

INTRODUCTION

Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by persistent difficulties in reciprocal social communication and interaction accompanied by limeISSN 1976-3026 OPEN ACCESS ited and repetitive patterns of behavior and interests [1] During development, social communication—the ability to exchange information and emotions through verbal and non-verbal means—is a critical and persistent challenge [2-4]. Although early research [5-7] found no specific deficits in structural language (e.g., phonology, syntax, or vocabulary) associated with social communication in patients with ASD, pragmatic language impairments (i.e., the appropriate social use of language) are consistently observed, even when structural language skills appear intact. Social communication refers to the ability to use language and non-verbal cues to share information, and feelings with others, requiring cognitive skills such as understanding that communication is a means of interpersonal connection [8,9].

Language can be broadly divided into two main components: structural language and non-verbal language, the latter encompassing pragmatic language such as emotional reciprocity, forming relationships, joint attention, and interpreting facial expressions [2-4]. In ASD, symptoms range from a complete absence of language to mild language delays or deficits. Among these, pragmatic impairments are particularly persistent throughout development, emphasizing the need to consider structural and pragmatic components as complementary rather than contrasting [10,11]. While structural language deficits may improve with age or targeted interventions such as speech therapy, pragmatic language impairments tend to become more pronounced over time and remain a major challenge [12]. Consequently, pragmatic language skills are critical determinants of effective social communication [13].

ASD diagnoses in children have been increasing worldwide [14]. While pharmacological options are available, they are largely limited to reducing repetitive behaviors, and no medication has proven effective in improving primary difficulties in ASD, such as socialization and communication [2,15]. As a result, nonpharmacological therapies for children with ASD, including speech therapy and applied behavioral analysis (ABA), remain central for improving language and communication skills. Therapeutic interventions should begin promptly after diagnosis, since early treatment can enhance neuroplasticity and positively influence developmental outcomes in young children [14,16,17]. However, despite the importance of early intervention and long-term care, these traditional therapeutic treatments impose significant economic strain and place additional burdens on families, in part owing to the spatial and temporal constraints of in-person sessions [18,19].

In contrast, compared with traditional therapeutic treatments, digital therapeutics do not impose spatial and temporal constraints, enabling patients to access therapy in their own homes via tablets or smartphones [20]. Moreover, mobile forms of therapy that function at home may provide an affordable method to meet the demand for early intervention in children with ASD [21] and also support continuity of care, which are critical challenges in traditional in-person sessions. Thus, increasing attention has been paid to digital therapeutic devices that can address the limitations of conventional treatment methods. However, despite this growing interest, few studies have explored the use of digital technology to enhance social communication skills in children with ASD, and many lack a foundation in child development theory [21,22].

Therefore, the present pilot trial aimed to verify the effectiveness of the “AVATA Cure” treatment device in improving the communication skills of children with ASD. The device was developed based on the principles of augmentative and alternative communication and evidence-based therapist-centered therapy, with modules designed to address both structural language and non-verbal communication. The program emphasized social communication, one of the central difficulties for children with ASD. Early studies regarding digital interventions demonstrated that emotion recognition training increased social interaction and understanding in children with ASD [23]. Additionally, the integration of gamification elements, such as scoring systems and positive feedback, enhances engagement and motivation, enabling children to practice social communication in a structured yet enjoyable environment [24].

Using the AVATA Cure, children with ASD can interact through speech and touch responses and practice joint attention by following the gaze of animated characters. These features are designed to facilitate social communication activities and strengthen interaction skills through digital therapy. By providing consistent practice opportunities while reducing the need for frequent in-person sessions, the AVATA Cure offers a potentially cost-effective and scalable solution for families seeking early intervention [25]. Thus, this study aims to evaluate the effectiveness of AVATA Cure in improving social communication, a key challenge for children with ASD, in a cohort of Korean children, demonstrating its potential as an accessible, structured intervention that complements traditional therapies.

METHODS

Participants

Between July and December 2023, 33 children with ASD were recruited from the Department of Psychiatry, CHA Bundang Medical Center (Seongnam, Republic of Korea). The inclusion criteria were: 1) age 1–7 years; 2) diagnosis of ASD based on detailed psychiatric interviews and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria; and 3) ability to use mobile applications on tablet PCs. The exclusion criteria were: 1) serious medical, sensory, or motor disabilities, and 2) reluctance or discomfort in using tablet PCs.

All study procedures were approved by the Institutional Review Board of CHA Bundang Medical Center (no. 2023-04-044-002). Participants and/or their guardians received a full explanation and a written description of the study procedures, and provided written informed consent before study initiation. In the case of children under 6 years of age, guardian consent was obtained; for children over 6 years of age with decision-making capacity, consent was obtained from both the participant and their guardian.

Of the 33 enrolled participants, three did not complete the study, and one had missing data at the second visit. Consequently, the analysis included 29 participants who completed all assessments.

Study design

At the first visit, a psychiatrist confirmed each child’s eligibility for the study. Eligible children and their guardians were given a comprehensive description of the study procedures and signed informed consent forms. A researcher trained in clinical psychology assessed the children’s communication skills using the Autism Diagnostic Observation Schedule-2 (ADOS-2); Sequenced Language Scale for Infants (SELSI) or Preschool Receptive-Expressive Language Scale (PRES); Social Communication Questionnaire (SCQ); and Korean Vineland Adaptive Behavior Scales 2nd edition (K-Vineland-II). The participants then received a tablet to use the digital AVATA Cure application at home for 8 weeks. Follow-up assessments of the participants’ communication skills were conducted 4 and 8 weeks from the date of their first visit by the same researcher. The Consolidated Standards of Reporting Trials (CONSORT) flow diagram of the study participants is shown in Figure 1.

Figure 1.

CONSORT flow diagram.

Intervention: digital therapeutics (AVATA Cure) application

The AVATA Cure application was the digital intervention applied in the present study and was delivered via a digital tablet. This application includes several modules targeting social communication abilities, such as joint attention and receptive, expressive, as well as pragmatic language (Figure 2A). For example, the joint attention module trains children to follow the gazes of characters and interact with specific objects. The receptive language module uses visual cues and simple instructions to improve comprehension, whereas the expressive language module uses visual aids to encourage children to form words or sentences. The pragmatic language module focuses on context-appropriate communication by simulating real-world conversational scenarios.

Figure 2.

The AVATA Cure digital therapeutics application. A: Contents of AVATA Cure digital therapeutics application. B: Screenshots from the AVATA Cure digital therapeutics application for example. B1: AVATA Cure programs are available on tablet device. B2: To prevent potential side effects, such as hyper-focus, a maximum daily running time has been set in AVATA Cure. B3: Participants’ application usage time was recorded individually and could be monitored by the researchers.

The application follows a predesigned protocol tailored for children with ASD, enabling interaction through speaking, touching, and other reactions on the tablet. Given the common ASD characteristics of restricted behaviors, specific interests, and hyperfocus, some children may be at risk for side effects such as overindulgence [26,27]. To mitigate this risk, AVATA Cure includes limits on maximum daily usage and session duration. Individual app usage times were recorded for each participant (Figure 2B). Additional details of the therapeutic intervention are provided in the Supplementary Figure 1.

All participants received a tablet preloaded with the AVATA Cure application at the first visit and began using it immediately. Participants and their parents were advised to engage with AVATA Cure for at least 30 min per day, 4 days per week, for a total of 960 min over the 8-week intervention period. Most children receive autism-related therapies, such as speech therapy, ABA, and sensory integration therapy. Participants and their guardians were instructed to maintain any ongoing autism-related therapies that had been initiated prior to study enrollment without substantial changes until the end of the study period. Information on concurrent therapies was collected via guardian reports and included the type of therapy, approximate duration of each session, and frequency of sessions during the study period. These concurrent therapies were part of routine clinical care, varied according to individual clinical needs, and were not standardized by the study protocol.

Social communication skill assessments

All participants responded to four standardized clinical outcome measures, including ADOS-2, SELSI or PRES, SCQ, and K-Vineland-II.

ADOS-2

The ADOS-2 is a semi-structured, standardized, observational instrument that uses questions and activities to evaluate communicative, social, and repetitive behaviors relevant to ASD diagnosis. It comprises five modules: Toddler, 1, 2, 3, and 4, which are selected primarily based on the individual’s expressive language level and secondarily on chronological age and task relevance to the individual’s interests and abilities. The Toddler Module is designed for preverbal children or those using single words aged 12–30 months, Module 1 for preverbal or single-word users aged 31 months and older, Module 2 for children using phrase speech, Module 3 for children or adolescents with fluent speech, and Module 4 for adolescents or adults with fluent speech. The evaluator determines the appropriate module for each individual based on the manual’s criteria, and scores are entered into a normed algorithm to assess ASD likelihood and symptom severity, with lower severity scores indicating less impairment [14]. The present study used the “reciprocal social interaction” total score as part of the social affect category. Previous studies have demonstrated strong internal consistency across all modules, with Cronbach’s alpha values ranging from 0.82 to 0.91 [28].

SELSI or PRES

The SELSI and PRES are scales used to measure language development, with the choice of scale determined according to the participants’ age and language level. SELSI was administered to children aged 4–35 months or to those older than 35 months whose language skills were low enough to warrant this scale. PRES was used for children aged 2–6 years. Both instruments evaluate the detailed aspects of language. In the present study, the receptive and expressive “pragmatics” scores were used to assess the participants’ ability to understand and express pragmatic understanding and expression by understanding the communication situation or the flow of the story, as outlined in the SELSI and PRES manuals [29,30]. The SELSI demonstrates strong internal consistency, with Cronbach’s alpha values of 0.99 for both receptive and expressed domains [30]. Similarly, the PRES shows strong internal consistency, with Cronbach’s alpha values of 0.95 for both receptive and expressive domains [29].

SCQ

The SCQ is used to evaluate communication skills and social functioning in children [31]. It comprises 40 items that comprehensively assess various aspects of social interaction abilities as well as verbal and non-verbal communication skills. Each item is answered with “yes” or “no.” In the present study, the SCQ was completed by the guardians of the children, and the resulting scores were used for analysis. Higher scores indicated greater communication deficits. Previous studies have demonstrated the strong internal consistency of this instrument, with a Cronbach’s alpha reaching 0.93 [32].

K-Vineland-II

The K-Vineland-II assesses adaptive behavior and personal and social functioning across four domains that assess each developmental step in communication, socialization, daily liv-ing skills, and motor adaptive skills. Each domain consists of subdomains (receptive, expressive, and written communication; personal, domestic, and community daily living skills; interpersonal relationship, play and leisure time, and coping skills; gross and fine motor skills) [33]. According to the K-Vineland-II manual, the “interpersonal relationship” and “play and leisure time” subdomains of the socialization scale include items that measure the ability to understand and use non-verbal communication to manage social interactions, capturing qualitative impairments in social interaction characteristic of children with ASD [34]. The present study collected V-scale scores for these two subdomains. Overall, the K-Vineland-II demonstrates strong internal consistency, with a Cronbach’s alpha value ranging from 0.96 to 0.99 [34].

Statistical analysis

To evaluate the effectiveness of AVATA Cure, changes in children’s communication skill evaluation scores were assessed at three time points: baseline (0-week; V1), mid-intervention (4-week; V2), and post-intervention (8-week; V3). Statistical analyses were performed using data from the 29 participants who completed all assessments (complete case analysis). Analyses were conducted using IBM SPSS Statistics for Windows, version 29.0 (IBM Corp.), with statistical significance set at p <0.05.

The Shapiro–Wilk test was used to test the normality of the data. For normally distributed data, changes in measurement scores over time were assessed using one-way repeated-measures analysis of variance (ANOVA). Sphericity was assessed using Mauchly’s test for one-way repeated-measures ANOVA, and when the assumption was violated, Greenhouse–Geissercorrected degrees of freedom were applied and reported. If the data were not normally distributed, the Friedman test examined overall differences, pairwise comparisons between visits were conducted using the Wilcoxon signed-rank test. Posthoc analyses were adjusted using the Bonferroni correction.

RESULTS

Demographic and clinical characteristics of the study participants

Table 1 shows the demographic and clinical characteristics of the study participants, including AVATA Cure total usage time and other autism-related therapy times, such as speech, ABA, and sensory integration therapy. The participants included 20 males (68.97%) and 9 females (31.03%) with a median age of 4 years (range: 1–6 years). Among the participants, 22 (75.86%) were verbal and 7 (24.14%) were non-verbal. The participants used the AVATA Cure application for a median of 13.8 hours (range: 2.05–32.83 hours) through the 8-week treatment period. In addition, the participants spent a median of 16.3 hours (range: 0–80.5 hours) on other therapies.

Sociodemographic characteristics of the study participants

Changes in social communication skills across visits

Table 2 and Figure 3 present the changes in social communication-related measures across the three visits (0-week, V1; 4-week, V2; 8-week, V3) highlighting whether significant improvements occurred over time following the AVATA Cure digital therapeutics intervention. In addition to statistical significance, effect sizes were examined to quantify the magnitude of change over time; the effect size estimates are presented in Table 2. Exploratory dose–response analyses did not reveal statistically significant associations between changes in clinical outcomes and AVATA Cure app usage time or concurrent therapy intensity (Supplementary Table 1). Exploratory subgroup analyses based on verbal status are also presented (Supplementary Table 2).

Changes in social communication skills at each visit (N=29)

Figure 3.

Score changes of social communication skill assessments after AVATA Cure digital therapeutics application. A: ADOS-2 reciprocal social interaction median score changes across the three visits. B: SELSI/PRES receptive pragmatics median score changes across the three visits. C: SELSI/PRES expressive pragmatics median score changes across the three visits. D: SCQ mean score changes across the three visits. E: K-Vineland-II interpersonal relationship mean score changes across the three visits. F: K-Vineland-II play and leisure time mean score changes across the three visits. ADOS-2, SCQ score, and higher SELSI/PRES, K-Vineland-II score indicates improvement. *p<0.05; ***p<0.001. ADOS-2, Autism Diagnostic Observation Schedule-2; SELSI, Sequenced Language Scale for Infants; PRES, Preschool Receptive-Expressive Language Scale; SCQ, Social Communication Questionnaire; K-Vineland-II, Korean Vineland Adaptive Behavior Scales 2nd edition.

ADOS-2 reciprocal social interaction

The Friedman test revealed a significant change in ADOS-2 scores (χ²=8.51, p=0.014), indicating notable differences in scores between visits. The Wilcoxon signed-rank test with Bonferroni correction was conducted to examine differences between each visit, the ADOS-2 “reciprocal social interaction” score significantly decreased from V1 (median=8, range=2–19) to V3 (median=7, range=1–17), indicating a positive effect.

SELSI/PRES receptive and expressive pragmatics

The Friedman test revealed a significant increase in the SELSI/PRES “receptive pragmatics” scores (χ²=29.62, p<0.001), indicating differences in scores between visits. Post-hoc analyses using the Wilcoxon signed-rank test with Bonferroni correction demonstrated a statistically reliable increase from V1 (median=4, range=1–13) to V2 (median=6, range=1–14) and from V2 to V3 (median=6, range=1–13). Similarly, “expressive pragmatics” scores significantly increased (χ²=22.61, p< 0.001), and post-hoc analysis with Bonferroni correction, demonstrated a significantly increased from V1 (median=6, range=2–19) to V2 (median=8, range=2–20) and from V2 to V3 (median=8, range=2–21). These findings indicated improvements both receptive and expressive pragmatic abilities.

SCQ

One-way repeated-measures ANOVA to examine the differences in SCQ scores revealed a significant main effect of time (F(2, 56)=8.61, p<0.001). Post-hoc analysis with Bonferroni correction revealed a significant decrease in V3 from V1. This indicated an improvement.

K-Vineland-II interpersonal relationship and play and leisure time

One-way repeated-measures ANOVA revealed a significant main effect on the K-Vineland-II “interpersonal relationship” score over time. Post-hoc analysis with Bonferroni correction revealed a significant increase from V1 to V3 (F(2, 56)=3.75, p=0.030). Furthermore, the “play and leisure time” scores also showed a significant main effect. Because Mauchly’s test indicated a violation of the sphericity assumption for this subdomain, the Greenhouse–Geisser correction was applied. Post-hoc analysis with Bonferroni correction revealed significant increases from V1 to V2 and V1 to V3 (F(1.57, 43.88)=10.04, p<0.001). Thus, both “interpersonal relationship” and “play and leisure time” scores showed improvements.

DISCUSSION

This pilot clinical trial is the first in Republic of Korea to evaluate the feasibility and preliminary efficacy of AVATA Cure, a mobile-based digital therapeutic, in enhancing social communication skills in children with ASD. Across the 8-week intervention, significant improvements were observed in multiple measures of social communication, including reciprocal social interaction, caregiver-reported communication, and adaptive social functioning. These findings suggest the potential of AVATA Cure as a feasible and scalable adjunct to conventional therapies in children with ASD.

A notable outcome was an improvement in reciprocal social interaction, as measured by ADOS-2. Gains in this domain suggest that children with ASD are better able to initiate and maintain shared exchanges such as eye contact, joint engagement, and affective reciprocity, which are essential foundations for later social development. Pragmatic language abilities, including both receptive and expressive domains in the SELSI/PRES, also significantly increased, indicating enhanced understanding and expression in social communication through comprehension of situational contexts or narrative flow. Receptive language improvements indicate a better grasp of communication situations or the flow of a story, whereas expressive language advancements indicate a better ability to convey thoughts and engage in conversations. These findings are consistent with the notion that pragmatic language deficits in children with ASD are key challenges that can be addressed through structured interventions [12,35]. The SCQ score also significantly decreased, indicating a positive improvement. Additionally, both interpersonal relationship and play and leisure time scores on the K-Vineland-II significantly increased, indicating improvements. These findings are consistent with earlier research showing that better social communication skills positively influence broader socialization and daily living skills [33,36].

Previous studies on digital therapeutics for autism have demonstrated the association between higher compliance with game-based mobile therapy and improved social communication [21]. Our results suggest that AVATA Cure, by encouraging interactions through speaking, touching, and joint attention via gaze-following of characters across multiple modules, may support the development of social communication skills in children with ASD. For instance, modules focusing on the joint attention of AVATA Cure may strengthen children’s ability to coordinate attention with social partners by repeatedly engaging them in behaviors, such as sustained gaze, gaze shifting, and pointing, which are considered foundational skills for social communication [37,38]. Moreover, activities involving AVATA Cure’s conversation and theory of mind-related modules may support pragmatic language development by providing structured opportunities for turn-taking and understanding others’ intentions, which are important for social communication skills [8,39]. However, the mechanisms underlying these improvements remain unclear, highlighting the need for further research to examine how AVATA Cure enhances social communication, potentially by targeting specific cognitive or social processes. Previous studies have linked digital therapeutics with increased adaptability and communication competencies in children with ASD [3]. While some digital interventions have been reported to enhance socialization, they mainly target emotion recognition, and others have not demonstrated improvements in communication outcomes. Our study is novel for its direct focus on pragmatic and functional social communication, demonstrating positive effects in this critical domain [3,40].

Socialization and communication are critical skills for children with ASD [2]. Previous studies indicate that children with ASD experience more pronounced impairments in social and pragmatic abilities compared with other developmental disorders [13]. The improvements observed in pragmatic language in the present study suggest that the AVATA Cure digital intervention, which focused on social communication skills, may specifically target these pragmatic deficits. Currently, no effective pharmacological treatments are available to improve the social communication skills of children with ASD, and traditional in-person therapies face limitations such as spatial, temporal, and economic constraints. Digital therapeutics overcome these barriers by enabling children to access interventions at home via tablets or smartphones [20,41]. This flexibility is particularly valuable for early intervention, providing an affordable and scalable approach to meet the growing demand for ASD therapies [21].

Several limitations should be acknowledged in this study. First, the sample was relatively small, and no control group was included, which limited the ability to draw causal inferences. Therefore, it was not possible to conclusively attribute the observed improvements solely to the intervention in our study, as they may be attributable to natural developmental changes or concurrent therapies. Furthermore, the relatively small sample size, restricted age range, and limited variation in participants’ language abilities may constrain the generalizability of our findings given the diversity of the ASD population. Therefore, future studies with larger and more diverse samples of children with ASD could enable subgroup analyses at the language level (e.g., verbal vs. nonverbal children). In the future, randomized controlled trials with larger sample sizes are required to corroborate these findings. Nonetheless, the potential of AVATA Cure as a complementary tool alongside other therapies should be further explored, including its specific impact and interactions with traditional interventions. Second, some assessments were based on the guardians’ subjective reports, which may be subject to response bias. To enhance the reliability of the assessment results, standardized observational instruments such as the ADOS-2 and interviewtype K-Vineland-II were also administered by a trained psychologist.

Despite these limitations, the significant improvements observed across multiple clinical measures provide preliminary evidence that AVATA Cure can improve social communication in children with ASD, complement existing therapies, and offer a scalable and accessible treatment option. Although some mean or median changes were modest, the observed effect sizes suggested that these improvements may be clinically meaningful in the context of a short-term pilot study involving children with ASD. Notably, in some assessments in this study, such as the SELSI/PRES, both receptive and expressive pragmatic language showed significant improvement over a 4-week period, with further improvement observed at the 8-week mark. Compared with traditional face-to-face therapies, which can be time-consuming and financially burdensome, AVATA Cure offers a practical alternative by reducing in-person session costs. Previous studies have demonstrated that digital interventions can significantly lower therapy-associated costs while maintaining accessibility for families in geographically isolated or underserved areas [19,20]. These economic advantages, combined with the targeted focus on social communication skills, suggest that AVATA Cure could be particularly beneficial for families facing financial and logistical challenges in accessing early interventions. Moreover, previous research has emphasized the importance of early intervention in children with ASD, as well as the financial burden of long-term and continuous treatment [14,16-18]. While AVATA Cure was effective for a relatively short period in the present study, it may also offer a cost-effective solution for maintaining long-term therapeutic benefits.

Taken together, these findings suggest that AVATA Cure could be used as an adjunctive therapy in clinical practice, alongside pre-existing interventions for ASD (e.g., speech therapy and ABA) to reinforce social communication skills between in-person sessions and across home or educational settings. Although there are no standardized guidelines for the clinical implementation of digital therapeutics for ASD, prior studies have emphasized the importance of providing caregivers with clear instructions regarding device use and appropriate intervention duration [40,42]. Therefore, clinicians should review the intended therapeutic targets and safety considerations (e.g., appropriate intervention duration and potential overuse) and provide guardians with guidance on supervised use and procedures for reporting concerns.

In conclusion, the results of this pilot study provide preliminary evidence that the AVATA Cure can enhance social communication skills in young children with ASD and complement traditional therapies. Notably, improvements were detectable as early as 4 weeks, suggesting that short-term interventions may have a meaningful impact. Future randomized controlled trials with larger samples, extended follow-up periods, and mechanistic analyses are warranted to confirm the efficacy of digital therapeutics and explore how they facilitate social communication gains. If validated, the AVATA Cure has the potential to evolve into a scalable and cost-effective tool for improving social communication, thereby addressing one of the most critical challenges in ASD intervention.

Supplementary Materials

The Supplement is available with this article at https://doi.org/10.30773/pi.2025.0354.

Supplementary Table 1.

Exploratory dose–response analyses between intervention exposure and changes in clinical outcome measures (V1–V3)

pi-2025-0354-Supplementary-Table-1.pdf
Supplementary Table 2.

Exploratory subgroup analysis comparing changes in clinical outcome measures (V1–V3) between verbal and non-verbal patients with ASD

pi-2025-0354-Supplementary-Table-2.pdf
Supplementary Figure 1.

Detailed Contents of AVATA Cure digital therapeutics application.

pi-2025-0354-Supplementary-Fig-1.pdf

Notes

Availability of Data and Material

The datasets generated and analyzed during the current study are not publicly available due to legal or ethical restrictions that protect patients’ privacy and consent but available from the corresponding author on reasonable request.

Conflicts of Interest

Some authors were involved in the development of the AVATA Cure digital therapeutic software. However, they had no role in the study design, data collection, data analysis, interpretation, or manuscript preparation.

Author Contributions

Conceptualization: Minkyung Kim, Hyun-Ju Kim, Tai Kiu Choi. Data curation: Minkyung Kim, Jisoo Lee, Hyun-Ju Kim, Tai Kiu Choi. Formal analysis: Minkyung Kim, Hyun-Ju Kim, Tai Kiu Choi. Funding acquisition: Tai Kiu Choi. Investigation: Minkyung Kim, Jisoo Lee, Hyun-Ju Kim, Tai Kiu Choi. Methodology: Minkyung Kim, Hyun-Ju Kim, Tai Kiu Choi. Resources: Minkyung Kim, Jisoo Lee, Seung Hyun Hong, MinYoung Kim, Hyunju Park, Suvin Yang, Hyun-Ju Kim, Tai Kiu Choi. Software: Heonsu Yoon, Jun Chang, Minhwa Chung, Yeon Kyu Jung. Supervision: Hyun-Ju Kim, Tai Kiu Choi. Validation: Minkyung Kim, Hyun-Ju Kim, Tai Kiu Choi. Writing—original draft: Minkyung Kim, Hyun-Ju Kim, Tai Kiu Choi. Writing—review & editing: Minkyung Kim, Jiyoung Kim, Seung Hyun Hong, Hyun-Ju Kim, Tai Kiu Choi.

Funding Statement

This research was supported by the development of digital therapeutics to improve communication ability of autism spectrum disorder patients through the Institute of Information & Communications Technology Planning & Evaluation (IITP), funded by the Ministry of Science and ICT (MIST), Republic of Korea (grant number 2022-0-00223). This funding was secured by T.K. Choi.

Acknowledgments

We appreciate all participants who aided in conducting this study.

References

1. Erden S, Nalbant K, Kılınç İ. Investigation of relaxin-3 serum levels in terms of social interaction, communication, and appetite as a biomarker in children with autism. Clin Psychopharmacol Neurosci 2022;20:135–142.
2. Clinch S, Hudgens S, Gibbons E, Willgoss T, Smith J, Polek E, et al. Quantitative and qualitative exploration of meaningful change on the vineland adaptive behavior scales (Vineland™-II) in children and adolescents with autism without intellectual disability following participation in a clinical trial. Patient Relat Outcome Meas 2023;14:337–354.
3. Voss C, Schwartz J, Daniels J, Kline A, Haber N, Washington P, et al. Effect of wearable digital intervention for improving socialization in children with autism spectrum disorder: a randomized clinical trial. JAMA Pediatr 2019;173:446–454.
4. Volden J, Coolican J, Garon N, White J, Bryson S. Brief report: pragmatic language in autism spectrum disorder: relationships to measures of ability and disability. J Autism Dev Disord 2009;39:388–393.
5. Boucher J. Articulation in early childhood autism. J Autism Child Schizophr 1976;6:297–302.
6. Boucher J. Word fluency in high-functioning autistic children. J Autism Dev Disord 1988;18:637–645.
7. Bartolucci G, Pierce SJ, Streiner D. Cross-sectional studies of grammatical morphemes in autistic and mentally retarded children. J Autism Dev Disord 1980;10:39–50.
8. Hale CM, Tager-Flusberg H. Social communication in children with autism: the relationship between theory of mind and discourse development. Autism 2005;9:157–178.
9. Kim SY, Song DY, Bong G, Han JH, Yoo HJ. Descriptive analysis of social interaction and communication skills of autistic children according to sibling status and characteristics. Psychiatry Investig 2024;21:44–51.
10. Bishop DV. Autism and specific language impairment: categorical distinction or continuum? Novartis Found Symp 2003;251:213–226. discussion 226-234, 281-297.
11. Hinde RA. Non-verbal communication Cambridge: Cambridge University Press; 1972.
12. Reindal L, Nærland T, Weidle B, Lydersen S, Andreassen OA, Sund AM. Structural and pragmatic language impairments in children evaluated for autism spectrum disorder (ASD). J Autism Dev Disord 2023;53:701–719.
13. Hage SVR, Sawasaki LY, Hyter Y, Fernandes FDM. Social communication and pragmatic skills of children with autism spectrum disorder and developmental language disorder. Codas 2022;34e20210075.
14. Granich J, Dass A, Busacca M, Moore D, Anderson A, Venkatesh S, et al. Randomised controlled trial of an iPad based early intervention for autism: TOBY playpad study protocol. BMC Pediatr 2016;16:167.
15. Reichow B, Barton EE, Boyd BA, Hume K. Early intensive behavioral intervention (EIBI) for young children with autism spectrum disorders (ASD). Cochrane Database Syst Rev 2012;10:CD009260.
16. Weitlauf AS, McPheeters ML, Peters B, Sathe N, Travis R, Aiello R, et al. Therapies for children with autism spectrum disorder: behavioral interventions update. Rockville (MD): Agency for Healthcare Research and Quality (US) [Internet] Available at: https://www.ncbi.nlm.nih.gov/books/NBK241444/. Accessed August 1, 2025.
17. Landa RJ. Diagnosis of autism spectrum disorders in the first 3 years of life. Nat Clin Pract Neurol 2008;4:138–147.
18. Baxter AJ, Brugha TS, Erskine HE, Scheurer RW, Vos T, Scott JG. The epidemiology and global burden of autism spectrum disorders. Psychol Med 2015;45:601–613.
19. Buescher AV, Cidav Z, Knapp M, Mandell DS. Costs of autism spectrum disorders in the United Kingdom and the United States. JAMA Pediatr 2014;168:721–728.
20. Choi J, Kim I, Park J. [Effects of video self-modeling using a smart devices on the math word problem solving for student with ASD]. J Spec Educ Rehabil 2015;54:403–423. Korean.
21. Penev Y, Dunlap K, Husic A, Hou C, Washington P, Leblanc E, et al. A mobile game platform for improving social communication in children with autism: a feasibility study. Appl Clin Inform 2021;12:1030–1040.
22. Scarcella I, Marino F, Failla C, Doria G, Chilà P, Minutoli R, et al. Information and communication technologies-based interventions for children with autism spectrum conditions: a systematic review of randomized control trials from a positive technology perspective. Front Psychiatry 2023;14:1212522.
23. Fridenson-Hayo S, Berggren S, Lassalle A, Tal S, Pigat D, Meir-Goren N, et al. ‘Emotiplay’: a serious game for learning about emotions in children with autism: results of a cross-cultural evaluation. Eur Child Adolesc Psychiatry 2017;26:979–992.
24. Atherton G, Cross L. The use of analog and digital games for autism interventions. Front Psychol 2021;12:669734.
25. Dawson G, Sapiro G. Potential for digital behavioral measurement tools to transform the detection and diagnosis of autism spectrum disorder. JAMA Pediatr 2019;173:305–306.
26. Ashinoff BK, Abu-Akel A. Hyperfocus: the forgotten frontier of attention. Psychol Res 2021;85:1–19.
27. Gunn KC, Delafield-Butt JT. Teaching children with autism spectrum disorder with restricted interests: a review of evidence for best practice. Rev Educ Res 2016;86:408–430.
28. Kim SY, Oh M, Bong G, Song DY, Yoon NH, Kim JH, et al. Diagnostic validity of autism diagnostic observation schedule, second edition (KADOS-2) in the Korean population. Mol Autism 2022;13:30.
29. Kim YT. [Content and reliability analyses of the preschool receptiveexpressive language scale (PRES)]. Commun Sci Disord 2000;5:1–25. Korean.
30. Kim YT. [Content and reliability analyses of the sequenced language scale for infants (SELSI)]. Commun Sci Disord 2002;7:1–23. Korean.
31. Jutley-Neilson J, Harris G, Kirk J. The identification and measurement of autistic features in children with septo-optic dysplasia, optic nerve hypoplasia and isolated hypopituitarism. Res Dev Disabil 2013;34:4310–4318.
32. Kim JH, Sunwoo HJ, Park SB, Noh DH, Jung YK, Cho IH, et al. [A validation study of the Korean version of social communication questionnaire]. J Korean Acad Child Adolesc Psychiatry 2015;26:197–208. Korean.
33. Balboni G, Tasso A, Muratori F, Cubelli R. The Vineland-II in preschool children with autism spectrum disorders: an item content category analysis. J Autism Dev Disord 2016;46:42–52.
34. Hwang ST, Kim JH, Hong SH, Bae SH, Jo SW. Standardization study of the Korean vineland adaptive behavior scales-II (K-Vineland-II). Kor J Clin Psychol 2015;34:851–876. Korean.
35. Baird G, Norbury CF. Social (pragmatic) communication disorders and autism spectrum disorder. Arch Dis Child 2016;101:745–751.
36. Balboni G, Pedrabissi L, Molteni M, Villa S. Discriminant validity of the Vineland Scales: score profiles of individuals with mental retardation and a specific disorder. Am J Ment Retard 2001;106:162–172.
37. Mundy P, Newell L. Attention, joint attention, and social cognition. Curr Dir Psychol Sci 2007;16:269–274.
38. Racine TP, Carpendale JIM. The role of shared practice in joint attention. Br J Dev Psychol 2007;25:3–25.
39. Tager-Flusberg H. Understanding the language and communicative impairments in autism. Int Rev Res Ment Retard 2000;23:185–205.
40. Fletcher-Watson S, Petrou A, Scott-Barrett J, Dicks P, Graham C, O’Hare A, et al. A trial of an iPad™ intervention targeting social communication skills in children with autism. Autism 2016;20:771–782.
41. Lee T, Kim S, Kim J, Park KJ, Kim HW. Efficacy of mobile-based cognitive training program DoBrain in preschool children with or without developmental disabilities: a randomized, single-blind, active-controlled trial. Psychiatry Investig 2022;19:1000–1011.
42. Kim E, Jeon H, Lee J, Oh H, Kim M, Shin J, et al. Developing and evaluating guidelines to prevent overdependence on digital therapeutics in children and adolescents: randomized controlled trial. J Med Internet Res 2025;27e69248.

Article information Continued

Figure 1.

CONSORT flow diagram.

Figure 2.

The AVATA Cure digital therapeutics application. A: Contents of AVATA Cure digital therapeutics application. B: Screenshots from the AVATA Cure digital therapeutics application for example. B1: AVATA Cure programs are available on tablet device. B2: To prevent potential side effects, such as hyper-focus, a maximum daily running time has been set in AVATA Cure. B3: Participants’ application usage time was recorded individually and could be monitored by the researchers.

Figure 3.

Score changes of social communication skill assessments after AVATA Cure digital therapeutics application. A: ADOS-2 reciprocal social interaction median score changes across the three visits. B: SELSI/PRES receptive pragmatics median score changes across the three visits. C: SELSI/PRES expressive pragmatics median score changes across the three visits. D: SCQ mean score changes across the three visits. E: K-Vineland-II interpersonal relationship mean score changes across the three visits. F: K-Vineland-II play and leisure time mean score changes across the three visits. ADOS-2, SCQ score, and higher SELSI/PRES, K-Vineland-II score indicates improvement. *p<0.05; ***p<0.001. ADOS-2, Autism Diagnostic Observation Schedule-2; SELSI, Sequenced Language Scale for Infants; PRES, Preschool Receptive-Expressive Language Scale; SCQ, Social Communication Questionnaire; K-Vineland-II, Korean Vineland Adaptive Behavior Scales 2nd edition.

Table 1.

Sociodemographic characteristics of the study participants

Sociodemographic variables Values (N=29)
Age (yr) 4 (1–6)
Gender
 Male 20 (68.97)
 Female 9 (31.03)
Verbal status
 Verbal 22 (75.86)
 Non-verbal 7 (24.14)
Digital therapeutics (AVATA Cure) total usage time (hr) 13.8 (2.05–32.83)
Other therapies time* (hr) 16.3 (0–80.5)

Values are presented as median (range) or number (%).

*

other therapy times (e.g., speech, applied behavior analysis, and sensory integration therapy).

Table 2.

Changes in social communication skills at each visit (N=29)

Baseline (V1) 4-week (V2) 8-week (V3) χ² or F Post-hoc analyses W or ηp²
ADOS-2
 Reciprocal social interaction 8 (2–19) 7 (2–18) 7 (1–17) 8.51* V1>V3 0.15
SELSI/PRES
 Receptive pragmatics 4 (1–13) 6 (1–14) 6 (1–13) 29.62*** V1<V2<V3 0.51
 Expressive pragmatics 6 (2–19) 8 (2–20) 8 (2–21) 22.61*** V1<V2<V3 0.39
SCQ 16.70±5.30 15.38±5.52 14.00±5.68 8.61*** V1>V3 0.24
K-Vineland-II
 Interpersonal relationship 7.93±2.07 8.17±2.35 8.51±2.20 3.75* V1<V3 0.12
 Play and leisure time 7.79±2.31 8.83±2.44 8.69±2.54 10.04*** V1<V2,V3 0.26

Values are presented as mean±standard deviation or median (range). Lower ADOS-2 and SCQ scores indicate improvement, whereas higher SELSI/PRES and K-Vineland-II scores indicate improvement.

*

p<0.05;

***

p<0.001;

Friedman test, Wilcoxon signed-rank test (Bonferroni correction);

repeated measures ANOVA (Bonferroni correction).

ADOS-2, Autism Diagnostic Observation Schedule-2; SELSI, Sequenced Language Scale for Infants; PRES, Preschool Receptive-Expressive Language Scale; SCQ, Social Communication Questionnaire; K-Vineland-II, Korean Vineland Adaptive Behavior Scales 2nd edition; ANOVA, analysis of variance.