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

NCT06477666 | Completed Results

• 1 other identifier: Resol HCS N° 10.480/2022
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neurodevelopmental Disorders; Autism Spectrum Disorder; Adaptive Behaviors

Keywords

Neurodevelopmental disorders; Autism; Adaptive behaviors

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Vineland-3 Communication Domain Score

  Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up)

• Vineland-3 Daily Living Skills Domain Score

  Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up)

• Vineland-3 Socialization Domain Score

  Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up)

Study Arms (1)

Sentido's® Model Intervention Group

EXPERIMENTAL

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

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.

Also known as: Sentido's® Transcomplexity Model

Sentido's® Model Intervention Group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sentido's CAIP & CICI Organización Terapéutica: lead

Study Sites (1)

Organización Terapéutica Sentido´s CAIP&CICI (Centro de Atención Integral Pediátrico y Centro de Intervención Conductual Intensiva)

Comodoro Rivadavia, Chubut Province, 9000, Argentina

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders; Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Child Development Disorders, Pervasive

Results Point of Contact

• Title: Bárbara Muriel Tomás
• Organization: Sentido´s CAIP & CICI

tomasbarbara@gmail.com

+54 2974635050

Study Officials

• Bárbara M Tomás, PhD(c)

  Instituto Universitario en Ciencias de la Salud - Fundación H. A. Barceló

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm pre-post intervention study with follow-up. All participants receive the same Sentido's® Model intervention for 14 weeks, followed by a 3-week follow-up period without direct intervention to assess maintenance of treatment gains. No control group or randomization employed in this preliminary effectiveness study.

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: June 27, 2024
• Study Start: October 30, 2023
• Primary Completion: June 7, 2025
• Study Completion: August 7, 2025
• Last Updated: April 8, 2026
• Results First Posted: April 8, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)