Description of the Impact of the Modelo Sentido's® on Adaptive Behaviors in Children With Autism

Sponsor
Sentido's CAIP & CICI Organización Terapéutica
Study ID
NCT06477666
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
3 Years - 7 Years
Healthy Volunteers
Not accepted

Interventions

  • Sentido's® Model — BEHAVIORAL
    The Sentido's® Model is an integrated intervention approach that combines Applied Behavior Analysis (ABA), Ayres Sensory Integration (ASI), and Psychoimmunoendocrinology (PINE) within a transcomplexity theoretical framework. The intervention addresses Bio-Neuro-Sensory-Psycho-Social-Spiritual-Occupational-Nutritional-Ecological dimensions of development through individualized treatment protocols. Sessions are delivered by trained therapists with active family participation in a specialized neurodevelopment center setting. The intervention duration is 14 weeks with protocol-specific scheduling based on individual participant needs.

Study Details

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.

Key Dates

Start date
Oct 30, 2023
Status verified
Aug 2025
Primary completion
Jun 7, 2025
Completion
Aug 7, 2025

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sentido's® Model Intervention Group
    Single intervention group receiving the Sentido's® Model for 14 weeks. Participants are children aged 3-7 years with autism spectrum disorder and associated neurodevelopmental challenges. All participants receive individualized intervention protocols combining ABA, ASI, and PINE approaches with family participation. Sessions are conducted at a specialized neurodevelopment center in Comodoro Rivadavia, Argentina. Following the 14-week active intervention period, participants undergo a 3-week follow-up assessment period without direct intervention to evaluate maintenance of treatment effects.

Primary Outcome Measure

Vineland-3 Adaptive Behavior Composite Score [ Time Frame: Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up) ]

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