N/A
Completed N=24
Description of the Impact of the Modelo Sentido's® on Adaptive Behaviors in Children With Autism
Neurodevelopmental Disorders · Autism Spectrum Disorder · Adaptive Behaviors
Source: ClinicalTrials.gov NCT06477666 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: Vineland-3 Adaptive Behavior Composite Score — 74.8; 87.5; 90.8 units on a scale — p=<0.001
Summary
Knowing the impact of the Modelo Sentido´s® (MS) on the gain of adaptive behaviors in children on the autism spectrum (AS) and other associated neurodevelopmental challenges (ANDC), is essential to improve the quality of life of children, families and professionals who live with neurodevelopmental challenges; inform parents about the efficacy and effectiveness of the interventions offered; provide scientific knowledge required by government agencies, public and private policy makers to make informed decisions about which intervention they should support; contribute with a manualized intervention program contextually appropriate to the strengths and challenge within a low- and middle-income country, which can potentially be modified by reverse engineering to apply it to environments that require it in high-income countries.
MS is a proposal for understanding and therapeutic intervention on the dimensional complexity involved in the challenges of neurodevelopment. MS provides a clinical practice framework that generates, drives, and sustains interaction and collaboration between disciplines converging in transdisciplinarity. MS promotes understanding, reasoning, and intervention on the Bio-Neuro-Sensory-Psycho-Social-Spiritual-Occupational-Nutritional-Ecological dimensions of childhoods in AS and other ANDC, their significant caregivers and intervening therapists. MS focuses its bases on three evidence-based frameworks: the applied behavior analysis (ABA), sensory integration (SI) and psychoimmunoneuroendocrinology (PINE) correlate of the neurobiology of stress. Which emerge from behavioral sciences, developmental sciences, neurosciences, and stress sciences. Evidence supports that interventions in children with AS beyond addressing core symptoms should focus on outcome measures, such as quality of life and adaptive functioning. MS focuses its programs on supporting and accompaniment to parents and significant caregivers as a fundamental aspect for gaining adaptive behaviors in childhood. MS provides tools that encourage and develop adaptive behaviors in childhood in EA and other ANDC; In turn, MS enhances the families' competencies, confidence, and caring skills towards their child.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vineland-3 Adaptive Behavior Composite Score |
74.8; 87.5; 90.8 | <0.001 sig |
| PRIMARY Goal Attainment Scaling (GAS) Scores |
0; 19; 20 | < 0.001 sig |
| PRIMARY Family Outcome Survey (FOS) Total Score |
68; 87; 91 | <0.001 sig |
| SECONDARY Vineland-3 Communication Domain Score |
61.3; 76.9; 79.1 | <0.001 sig |
| SECONDARY Vineland-3 Daily Living Skills Domain Score |
82.3; 92.0; 94.7 | <0.001 sig |
| SECONDARY Vineland-3 Socialization Domain Score |
77.5; 94.1; 95.9 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Informed consent signed by the parent or guardian.
- Complete the executive admission requirements (see ANNEX).
- Meet the diagnostic impression criteria for DSM-V neurodevelopmental disorders:
- Intellectual disability (ID); global developmental delay (RDSM) or psychomotor delay (PMR);
- Communication disorders: language disorders (TL), speech disorders, social communication disorder (SUD), childhood-onset disfluency;
- Autism spectrum disorder (ASD)
- Attention-deficit/hyperactivity disorder (ADHD) - Motor development disorders: developmental coordination disorder (DCD), stereotypic movement disorder, tic disorders, Tourette's disorder (TT), chronic tic disorder (CTT), transient tic disorder;
- Specific learning disorders ( TAp ).
- Answer the GAS, Vineland-3 and FOS scales, at therapeutic admission.
- Willingness of significant caregivers to accompany the intervention process, for twelve sessions according to syllabus protocol.
Exclusion Criteria
- Childhoods that exceed the age of 7 years in the study period.
- Children diagnosed with neurological or genetic diseases, brain injury, visual, auditory or motor sensory deficits.
- Children who are under the guardianship of the Argentine State.
Data sourced from ClinicalTrials.gov (NCT06477666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.