Trial results for a study investigating the Modelo Sentido's® intervention in children with Autism were posted on ClinicalTrials.gov on 2026-04-08, showing a mean increase of 16.0 in Vineland-3 Adaptive Behavior Composite Scores.
Background
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by challenges in social interaction, communication, and restricted or repetitive behaviors. Interventions aimed at improving adaptive behaviors are crucial for enhancing the quality of life for individuals with autism and their families. The Modelo Sentido's® (MS) intervention seeks to address these challenges by promoting gains in adaptive behaviors, providing a manualized approach that can inform parents, professionals, and policymakers about effective strategies to support children with neurodevelopmental challenges.
Trial design
This completed study, identified as Phase NA, enrolled 24 participants with conditions including Neurodevelopmental Disorders, Autism Spectrum Disorder, and challenges with Adaptive Behaviors. The trial was designed as a single-arm pre-post intervention study with repeated measures. All participants received the Modelo Sentido's® intervention, serving as their own controls. Measurements were taken at three time points: baseline (pre-test), 14 weeks (post-intervention), and 17 weeks (follow-up after a 3-week washout period).
Key results
The study reported significant improvements in several adaptive behavior measures following the Modelo Sentido's® intervention:
- The Vineland-3 Adaptive Behavior Composite Score showed an increase from a baseline mean of 74.8 (Standard Deviation 17.8) to 87.5 (Standard Deviation 19.4) post-intervention at 14 weeks, and further to 90.8 (Standard Deviation 20.6) at 17-week follow-up. An ANOVA analysis indicated a mean difference (Net) of 16.0 (95% CI: 10.086 to 21.914) with a p-value of 0.001.
- Goal Attainment Scaling (GAS) Scores also demonstrated positive outcomes. For overall GAS scores, the proportion of participants achieving expected or better was 0.833 (95% CI: 0.625 to 0.938) with a p-value of 0.001. Similar results were seen for specific objectives: 0.833 (95% CI: 0.625 to 0.938) for Objective 1, 0.75 (95% CI: 0.53 to 0.893) for Objective 2, and 0.652 (95% CI: 0.432 to 0.822) for Objective 3, all with a p-value of 0.001.
- The Vineland-3 Communication Domain Score improved from a baseline mean of 61.3 (Standard Error 3.6) to 76.9 (Standard Error 4.0) post-intervention, and 79.1 (Standard Error 4.2) at follow-up. The mean difference (Net) was 17.875 (95% CI: 10.291 to 25.459) with a p-value of 0.001.
- The Vineland-3 Daily Living Skills Domain Score increased from a baseline mean of 82.3 (Standard Error 3.0) to 92.0 (Standard Error 3.7) post-intervention, and 94.7 (Standard Error 3.9) at follow-up.
What this means
The results from this study suggest that the Modelo Sentido's® intervention may lead to significant improvements in adaptive behaviors, communication skills, and daily living skills for children with Autism Spectrum Disorder. The observed increases in Vineland-3 scores and the high proportion of participants achieving their individualized goals indicate that the intervention could be an effective tool for enhancing the quality of life for these children. The statistically significant improvements across multiple domains provide evidence for the potential efficacy of this manualized intervention in supporting neurodevelopmental progress.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06477666, titled "Description of the Impact of the Modelo Sentido's® on Adaptive Behaviors in Children With Autism", were posted on 2026-04-08 on clinicaltrials.gov.