Development of a Social Communication Intervention Mobile App for Adolescents With Autism Spectrum Disorder and Social Communication Disorder: Protocol for a Pilot Randomized Clinical Trial
Notice bibliographique
Résumé
BACKGROUND: Autism spectrum disorder (ASD) and social communication disorder (SCD) are neurodevelopmental disorders characterized by deficits in social communication that hinder social adaptation, with limited pharmacological options for therapy owing to the absence of identified biomarkers. Individuals with ASD or SCD require lifelong interventions tailored to their development stages. However, most existing interventions primarily focus on early childhood, leaving adolescents relatively underserved. Moreover, timely access to interventions is often limited by geographic and economic barriers as specialized clinics and therapists tend to be concentrated in major urban areas. OBJECTIVE: This pilot randomized clinical trial aimed to evaluate the initial safety and efficacy of NDTx-01, a digital therapeutic (DTx) for adolescents with ASD or SCD. NDTx-01 was designed to overcome the accessibility limitations by integrating cognitive behavioral therapy principles, story-based interventions, and gamification elements. METHODS: We introduce a protocol for a multicenter, prospective, assessor-blinded pilot randomized clinical trial involving children and adolescents aged 10 to 18 years diagnosed with ASD or SCD. Participant enrollment was conducted at 3 major medical hospitals. Enrolled participants were randomly assigned to either the intervention group (NDTx-01 and treatment as usual [TAU]) or the control group (TAU only). TAU included medications and therapeutic services. Participants were instructed to use the app approximately 10 minutes per day, 5 days a week. To evaluate the efficacy of NDTx-01, standardized tools were administered, including the Korean version of the Vineland Adaptive Behavior Scales, Second Edition (K-VABS-II); the Social Responsiveness Scale, Second Edition; Clinical Global Impressions-Severity (CGI-S); Clinical Global Impressions-Improvement (CGI-I); the Social Communication Questionnaire; and the Korean version of the Stress Index for Parents of Adolescents. Assessments were conducted in weeks 0, 1, 2, 4, and 6, except for K-VABS-II, CGI-S, and CGI-I, which were administered only in weeks 0, 4, and 6. Statistical analyses were conducted using the SAS software. Between-group differences were assessed using independent 2-tailed 2-sample t tests or Wilcoxon rank sum tests. Within-group changes were evaluated using paired t tests or Wilcoxon signed rank tests. RESULTS: From August 2024 to December 2024, a total of 42 individuals were screened, 39 (93%) participants who met the inclusion criteria were enrolled, and 1 participant withdrew consent; the remaining participants completed the study. The pilot randomized clinical trial was successfully completed, and the results were published in April 2025. As of 2025, we are conducting a confirmatory clinical trial at 5 major hospitals across South Korea. CONCLUSIONS: The results of this pilot clinical trial provided important insights into the initial safety and efficacy of DTx as interventions for adolescents with ASD and SCD. Both groups demonstrated statistically significant improvements in adaptive skills and socialization. TRIAL REGISTRATION: Clinical Research Information Service KCT0009140; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=26713. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/66419.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,026 | 0,022 |
| Méta-épidémiologie (sens strict) | 0,005 | 0,003 |
| Méta-épidémiologie (sens large) | 0,008 | 0,004 |
| Bibliométrie | 0,002 | 0,002 |
| Études des sciences et des technologies | 0,004 | 0,003 |
| Communication savante | 0,003 | 0,003 |
| Science ouverte | 0,003 | 0,002 |
| Intégrité de la recherche | 0,005 | 0,008 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,074 | 0,011 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».