Neurodevelopmental DisordersSentido´sNCT06477666
Description of the Impact of the Modelo Sentido's® on Adaptive Behaviors in Children With Autism
A study testing Sentido's® Model in people with Neurodevelopmental Disorders and Autism Spectrum Disorder, run by Sentido's CAIP & CICI Organización Terapéutica at 1 site in Argentina.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Neurodevelopmental Disorders, Autism Spectrum Disorder, Adaptive Behaviors
- What is being tested?
- Sentido's® Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteArgentina
- Study dates
- 30 Oct 2023to 7 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Organización Terapéutica Sentido´s CAIP&CICI (Centro de Atención Integral Pediátrico y Centro de Intervención Conductual Intensiva)
Comodoro Rivadavia, Chubut Province, 9000
About this study
Official title: 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.
Read the 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.
- Being tested
- Sentido's® Model
- Keywords
- Neurodevelopmental disorders, Autism, Adaptive behaviors
- Medical subject headings
- Neurodevelopmental Disorders, Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentido's® ModelBehavioural
Also called Sentido's® Transcomplexity 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sentido's® Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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).
Measured: Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up)
Secondary outcomes (3)
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)
Measured: 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).
Measured: 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).
Measured: Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start30 Oct 2023
- Primary completion7 Jun 2025
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sentido's CAIP & CICI Organización Terapéutica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bárbara M Tomás, PhD(c), Principal investigator, Instituto Universitario en Ciencias de la Salud - Fundación H. A. Barceló
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477666
- Sponsor's protocol ID
- Resol HCS N° 10.480/2022
- Acronym
- Sentido´s
- Status last verified
- Aug 2025
- First submitted
- 12 Jan 2024
- Last updated
- 8 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06477666
- Acronym / sponsor ID
- Sentido´s / Resol HCS N° 10.480/2022
- Keywords
- Neurodevelopmental disorders, Autism, Adaptive behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sentido's CAIP & CICI Organización TerapéuticaUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 7 Jun 2025 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 27 Jun 2024 (actual)
- Results
- Posted 8 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sentido's® Model Intervention Group | Experimental | Behavioral: Sentido's® ModelSingle 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. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentido's® ModelAlso: Sentido's® Transcomplexity ModelThe 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. | Behavioural | Sentido's® Model Intervention Group |
Primary outcome
Vineland-3 Adaptive Behavior Composite Score
Time frame: Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up)
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)
Goal Attainment Scaling (GAS) Scores
Time frame: Baseline (Week 0), Post-intervention (Week 14), Follow-up (Week 17)
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)
Family Outcome Survey (FOS) Total Score
Time frame: Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up)
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).
3 secondary outcomes
Vineland-3 Communication Domain Score
Time frame: Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up)
Vineland-3 Daily Living Skills Domain Score
Time frame: Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up)
Vineland-3 Socialization Domain Score
Time frame: Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bárbara M Tomás, PhD(c) principal investigator
Instituto Universitario en Ciencias de la Salud - Fundación H. A. Barceló
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentido's® Model in people with Neurodevelopmental Disorders and Autism Spectrum Disorder, run by Sentido's CAIP & CICI Organización Terapéutica at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vineland-3 Adaptive Behavior Composite Score (time frame: Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.