Viewing Study NCT06477666



Ignite Creation Date: 2024-07-17 @ 11:30 AM
Last Modification Date: 2024-10-26 @ 3:33 PM
Study NCT ID: NCT06477666
Status: RECRUITING
Last Update Posted: 2024-06-27
First Post: 2024-01-12

Brief Title: Description of the Impact of the Modelo Sentidos on Adaptive Behaviors in Children With Autism
Sponsor: Sentidos CAIP CICI Organización Terapéutica
Organization: Sentidos CAIP CICI Organización Terapéutica

Study Overview

Official Title: Description of the Impact of the Modelo Sentidos on the Adaptive Behaviors of Children Between 3 and 7 Years Old on the Autism Spectrum and Other Associated Neurodevelopmental Challenges
Status: RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Sentidos
Brief Summary: Knowing the impact of the Modelo Sentidos 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 Sentidos 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 Sentidos 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 behaviorsskills 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None