NCT06477666Completed
Description of the Impact of the Modelo Sentido's® on Adaptive Behaviors in Children With Autism
Description of the Impact of the Modelo Sentido's® on the Adaptive Behaviors of Children Between 3 and 7 Years Old, on the Autism Spectrum and Other Associated Neurodevelopmental Challenges
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 12 Jan 2024
- Start date
- 30 Oct 2023
- Primary completion date
- 7 Jun 2025
- Lead sponsor
- Sentido's CAIP & CICI Organización Terapéutica
- Diseases
- Autism
- NCT number
- NCT06477666
What you commit to
- Study type: Interventional
- Participants enrolled: 24
- From 30 Oct 2023 to the primary completion date, 7 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Children diagnosed with neurological or genetic diseases, brain injury, visual, auditory or motor sensory deficits.
Age
- Childhoods that exceed the age of 7 years in the study period.
Other
- Children who are under the guardianship of the Argentine State.
Who the study is looking for
- 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.
Age in the registry: 3 years to 7 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Organización Terapéutica Sentido´s CAIP&CICI (Centro de Atención Integral Pediátrico y Centro de Intervención Conductual Intensiva) Coordinator of this site? Confirm its status | Comodoro Rivadavia | Argentina | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.