Impact of Modelo Sentido's® on Adaptive Behaviors in Children with Autism
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
This study is testing whether the Modelo Sentido's® program can help improve daily skills in children aged 3 to 7 with autism or other developmental challenges.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 3 Years to 7 Years |
| Sex | All |
| Sponsor | Sentido's CAIP & CICI Organización Terapéutica Academic / other |
| Locations | 1 site (Comodoro Rivadavia, Chubut) |
| Trial ID | NCT06477666 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the impact of the Modelo Sentido's® (MS) intervention on the adaptive behaviors of children aged 3 to 7 years who are on the autism spectrum or have other neurodevelopmental challenges. The study will involve three phases, where health professionals will administer scales to caregivers before and after the intervention to evaluate changes in adaptive behaviors. The goal is to improve the quality of life for children and their families, inform parents about intervention efficacy, and provide data to policymakers for better decision-making regarding support for neurodevelopmental interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 to 7 years diagnosed with autism spectrum disorder or other associated neurodevelopmental disorders.
Not a fit: Patients who do not meet the diagnostic criteria for neurodevelopmental disorders or are outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life for children with autism and their families by providing effective intervention strategies.
How similar studies have performed: While the approach of using the Modelo Sentido's® is contextually tailored, similar interventions have shown promise in improving adaptive behaviors in children with autism, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Comodoro Rivadavia, Chubut
- Organización Terapéutica Sentido´s CAIP&CICI (Centro de Atención Integral Pediátrico y Centro de Intervención Conductual Intensiva) — Comodoro Rivadavia, Chubut, Argentina (Recruiting)
Study contacts
- Principal investigator: Bárbara M Tomás, PhD(c) — Instituto Universitario en Ciencias de la Salud - Fundación H. A. Barceló
- Study coordinator: Bárbara M Tomás, PhD(c)
- Email: tomasbarbara@gmail.com
- Phone: +54 297 4 635050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.