Description of the Impact of the Modelo Sentido's® on Adaptive Behaviors in Children With Autism
Launched by SENTIDO'S CAIP & CICI ORGANIZACIÓN TERAPÉUTICA · Jun 21, 2024
Trial Information
Current as of July 21, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a program called Modelo Sentido® (MS) on helping children with autism and other developmental challenges improve their everyday skills, known as adaptive behaviors. The goal is to enhance the quality of life for these children and their families by providing a structured approach that includes support for both the child and their caregivers. The program combines different methods from behavioral and developmental sciences to help children learn better ways to interact with their environment and manage their daily activities.
To participate in the study, children aged between 3 and 7 years who have been diagnosed with autism or related developmental disorders may be eligible, as long as their parent or guardian provides consent. Participants will engage in twelve sessions designed to support their growth in adaptive behaviors, and caregivers are encouraged to be involved throughout the process. It’s important to note that children with certain neurological or genetic conditions, or those who have experienced significant sensory deficits, are not eligible for this trial. Overall, the trial aims to gather valuable information that can help improve interventions for children with developmental challenges, particularly in low- and middle-income countries.
Gender
ALL
Eligibility criteria
- 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.
About Sentido's Caip & Cici Organización Terapéutica
Sentido's CAIP & CICI Organización Terapéutica is a leading clinical trial sponsor dedicated to advancing innovative therapeutic solutions through rigorous research and development. With a commitment to improving patient outcomes, the organization specializes in the design and execution of clinical trials across various therapeutic areas. Our multidisciplinary team of experts collaborates closely with healthcare professionals, regulatory bodies, and academic institutions to ensure the highest standards of scientific integrity and ethical conduct. By leveraging cutting-edge methodologies and a patient-centric approach, Sentido aims to contribute significantly to the evolution of modern medicine and address unmet medical needs.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Comodoro Rivadavia, Chubut, Argentina
Patients applied
Trial Officials
Bárbara M Tomás, PhD(c)
Principal Investigator
Instituto Universitario en Ciencias de la Salud - Fundación H. A. Barceló
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported