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

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

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.

Study Overview

• Status: Completed
• Conditions: Neurodevelopmental Disorders; Autism Spectrum Disorder; Adaptive Behaviors
• Intervention / Treatment: Behavioral: Sentido's® Model

Detailed Description

Describing the impact of the Modelo Sentido's® on the adaptive behaviors of children from 3 to 7 years old, on the autism spectrum and other associated neurodevelopmental challenges, is extremely important for at least 5 (five) reasons. First, and most importantly, improve the quality of life of children, families and professionals who live with neurodevelopmental challenges. Secondly, parents need to be informed about the efficacy and effectiveness of the interventions offered. Third, this type of scientific knowledge is required by government agencies, public and private policy makers, as well as prepaid and social works so that they can make informed decisions about what type of intervention they should support. Fourth, contribute to the availability of a manualized intervention program contextually appropriate to the strengths and challenges within a low- and middle-income country, which could potentially be modified by reverse engineering to apply to environments that require it in high-income countries. Fifth, provide evidence-based data and know if the programs created through MS adjust to the population needs and cultural particularities of our region.

This study will be carried out in three time phases, through scales administered by health professionals to the significant caregivers (parents, grandparents or legal guardians) of the participants: the 1st phase will be before starting the intervention at the time of therapeutic admission, the 2nd phase will be after 14 weeks of intervention, and, the 3rd phase will be after two weeks without intervention at week 17 of the study.

Modelo Sentido´s is a proposal for understanding and therapeutic intervention on the dimensional complexity involved in neurodevelopmental challenges, which are a group of heterogeneous conditions that are characterized by an alteration in the acquisition of skills in a variety of developmental domains. including motor, social, language and cognition, are associated with difficulties in cognitive, behavioral, social, academic, and adaptive functioning; Within these, the autism spectrum is characterized by widespread deficits in social communication skills, restricted and repetitive interests and behaviors, and sensory difficulties that affect individual and family functioning. This new conception of the Autism Spectrum (AS) and other Associated Neurodevelopmental Challenges (ANDCH) has led to the search for more global, early, and intensive practices that adopt transdiagnostic intervention approaches. The availability of manualized and contextually appropriate intervention programs presents an additional challenge within low- and middle-income countries. Despite these limitations, different studies are conclusive based on information that allows us to trace a path from the theory of change towards innovations. Worldwide. spectrum of autism care in low- and middle-income countries, which could potentially be reverse engineered to apply to settings requiring it in high-income countries.

Sense Model (MS) highlights in its processes the perspective of transcomplexity, which is immersed in various metadomains of knowledge were psychology, anthropology, spirituality, linguistics, ecology, economics, history, philosophy, among other.

MS provides a clinical practice framework that generates, drives, and sustains interaction and collaboration between disciplines that converge in transdisciplinarity; promotes understanding, reasoning, and intervention on the Bio-Neuro-Sensory-Psycho-Social-Spiritual-Occupational-Nutritional-Ecological dimensions of childhoods in AS and other ANDCH, of their significant caregivers and intervening therapists.

MS focuses its foundations on three evidence-based frameworks; applied behavioral analysis (ABA), sensory integration (SI) and psychoimmunoneuroendocrinology (PINE) as main stress medicine (correlated with stress neurobiology). Which arise from behavioral sciences, developmental sciences, neurosciences, and stress sciences. MS focuses his work on the acquisition of adaptive behaviors/skills, driven by various research that confirms that children with AD show adaptive skills in different lower domains compared to those of children with typical development. Evidence suggests that interventions in children with AD, beyond addressing core symptoms, should focus on outcome measures, such as quality of life and adaptive functioning. Studies of young children suggest that more responsive caregivers are more likely to develop relationships.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Chubut Province
    • Comodoro Rivadavia, Chubut Province, Argentina, 9000
      • Organización Terapéutica Sentido´s CAIP&CICI (Centro de Atención Integral Pediátrico y Centro de Intervención Conductual Intensiva)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Study Population

All infants on the autism spectrum and other associated neurodevelopmental disorders, between 3 and 7 years old, attending Sentido's CAIP&CICI (Centro de Atención Integral Pediátrico y Centro de Intervención Conductual Intensiva) Therapeutic Organization, in Comodoro Rivadavia (Chubut Argentina), from September 2023 to October 2024.

Description

Inclusion Criteria:

1. Informed consent signed by the parent or guardian.
2. Complete the executive admission requirements (see ANNEX).

3. 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 ).
4. Answer the GAS, Vineland-3 and FOS scales, at therapeutic admission.
5. Willingness of significant caregivers to accompany the intervention process, for twelve sessions according to syllabus protocol.

Exclusion Criteria:

1. Childhoods that exceed the age of 7 years in the study period.
2. Children diagnosed with neurological or genetic diseases, brain injury, visual, auditory or motor sensory deficits.
3. Children who are under the guardianship of the Argentine State.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Behavioral: Sentido's® Model; 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.; Other Names: Sentido's® Transcomplexity Model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vineland-3 Adaptive Behavior Composite Score	The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Parent/Caregiver Comprehensive Interview Form assesses adaptive functioning across Communication, Daily Living Skills, Socialization, and Motor domains. The Adaptive Behavior Composite (ABC) is a summary standard score representing overall adaptive functioning. Standard scores have a mean of 100 and SD of 15, with higher scores indicating better adaptive functioning. The ABC was measured at baseline, 14 weeks (post-intervention), and 17 weeks (follow-up). Change was assessed using repeated measures ANOVA comparing scores across the three time points. The values reported in the Outcome Measure data table represent standardized scores (standard scores), not raw scores. Unabbreviated scale title: Vineland Adaptive Behavior Scales, Third Edition. Minimum value: 20 Maximum value: 160 Higher scores mean: Better outcome (better adaptive functioning)	Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up)
Goal Attainment Scaling (GAS) Scores	Goal Attainment Scaling (GAS) is a personalized outcome measure quantifying progress toward individually defined therapeutic goals. Each of the 24 participants had 3 goals established collaboratively with therapists at baseline. Progress was rated on a modified 5-point ordinal scale: -2 (baseline level/no progress), -1 (less than expected), 0 (expected), +1 (somewhat more than expected), +2 (much more than expected). Higher scores indicate greater goal attainment. The Outcome Measure data table reports the number of participants who achieved expected progress or better (scores ≥0) for each objective at each time point. Data are reported as frequency distributions across score categories. Goals were assessed at baseline, 14 weeks (post-intervention), and 17 weeks (follow-up). Full scale name: Goal Attainment Scaling Raw scale: 5-point ordinal from -2 to +2 Higher scores mean: Better outcome (greater goal attainment)	Baseline (Week 0), Post-intervention (Week 14), Follow-up (Week 17)
Family Outcome Survey (FOS) Total Score	The Family Outcome Survey (FOS) is a validated self-report questionnaire that assesses family quality of life and the impact of therapeutic services on family functioning. The FOS generates a total score ranging from 0 to 100, with higher scores indicating better family outcomes and satisfaction with services. The survey was administered to caregivers at baseline, 14 weeks (post-intervention), and 17 weeks (follow-up). Change was assessed using repeated measures ANOVA. Full scale name: Family Outcome Survey Score range: 0-100 Higher scores mean: Better outcome (improved family functioning and satisfaction with therapeutic services).	Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vineland-3 Communication Domain Score	The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Communication domain assesses receptive, expressive, and written communication skills. The domain yields a standard score (mean=100, SD=15), with higher scores indicating better communication functioning. Scores were measured at baseline, 14 weeks (post-intervention), and 17 weeks (follow-up). Change was assessed using repeated measures ANOVA. Unabbreviated scale title: Vineland Adaptive Behavior Scales, Third Edition - Communication Domain Score range: 20-160 Higher scores mean: Better outcome (better communication skills)	Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up)
Vineland-3 Daily Living Skills Domain Score	The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Daily Living Skills domain assesses personal, domestic, and community living activities. The domain yields a standard score (mean=100, SD=15), with higher scores indicating better daily living skills. Scores were measured at baseline, 14 weeks (post-intervention), and 17 weeks (follow-up). Change was assessed using repeated measures ANOVA. Unabbreviated scale title: Vineland Adaptive Behavior Scales, Third Edition - Daily Living Skills Domain Score range: 20-160 Higher scores mean: Better outcome (better daily living skills).	Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up)
Vineland-3 Socialization Domain Score	The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Socialization domain assesses interpersonal relationships, play and leisure time, and coping skills. The domain yields a standard score (mean=100, SD=15), with higher scores indicating better socialization. Scores were measured at baseline, 14 weeks (post-intervention), and 17 weeks (follow-up). Change was assessed using repeated measures ANOVA. Unabbreviated scale title: Vineland Adaptive Behavior Scales, Third Edition - Socialization Domain Score range: 20-160 Higher scores mean: Better outcome (better socialization skills).	Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up)

Collaborators and Investigators

• Sponsor: Sentido's CAIP & CICI Organización Terapéutica
• Investigators: Principal Investigator: Bárbara M Tomás, PhD(c), Instituto Universitario en Ciencias de la Salud - Fundación H. A. Barceló

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Actual): June 7, 2025
• Study Completion (Actual): August 7, 2025

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: March 28, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Autism; Neurodevelopmental disorders; Adaptive behaviors
• Additional Relevant MeSH Terms: Mental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder; Neurodevelopmental Disorders
• Other Study ID Numbers: Resol HCS N° 10.480/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No