Autistic disorder
Conditions
Interventions
The controlled and randomized clinical trial will include 160 children aged 3 to 12 years, with Autism Spectrum Disorder of different levels of severity who participate in the Program for Comprehensiv
E02.774
Sponsors
Universidade do Sul de Santa Catarina
Universidade do Sul de Santa Catarina
Eligibility
Age
3 Years to 12 Years
Inclusion criteria
Inclusion criteria: Children aged between 3 and 12 years; both sexes; diagnosed with Autistic Spectrum Disorder, regardless of the degree of severity, gender, race, ethnicity or type of treatment they are undergoing
Exclusion criteria
Exclusion criteria: Are undergoing medical treatment and using medications for non-Autism Spectrum Disorder-related pathologies (e.g., diabetes, cancer, epilepsy). Have any comorbidity that prevents the use of Photobiomodulation (photosensitivity or other conditions). Discontinue the ongoing conventional multiprofessional treatment at Comprehensive Care Program for Children and Adolescents - PAICA or initiate a new treatment during the study. Have had an unstable medical condition in the last thirty days. Interrupt the treatment for more than one week or miss more than two Photobiomodulation sessions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Functioning Assessment Scale. This scale will be used to verify the improvement in the level of severity of Autistic Aspect Disorder symptoms presented by the subjects of this research, in the version translated and validated into Brazilian Portuguese. The scale assesses behavior in 14 domains commonly affected in Autistic Aspect Disorder and has another category of “general impressions”. These 15 items include: personal relationships, imitation, emotional response, body use, use of objects, response to change, visual response, auditory response, response and use of taste, smell and touch, fear or nervousness, verbal communication, non- verbal, level of activity, level and consistency of intellectual response, and general impressions. The scores for each domain range from 1 (within normal limits) to 4 (severe autistic symptoms). The score varies from 15 to 60 and the cut-off point for Autistic Aspect Disorder is 30, being applied before the beginning and two more times throughout the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The Autism Treatment Evaluation Checklist scale will be applied, which was specifically designed to measure changes in the severity of Autism spectrum disorder, making it useful for monitoring behaviors over time, as well as tracking the effectiveness of a treatment. The Autism Treatment Evaluation Checklist is composed of four subscales: (1) Speech / Language / Communication, (2) Sociability, (3) Sensory / Cognitive Sensitivity, and (4) Health / Physicality / Behavior. Subscales provide researchers with information about specific areas of behavior that may change over time. Higher scores indicate more problems in each domain. The total score can vary from 0 to 179. It will be performed before the intervention, soon after, three and six months after the end of the treatment.;A Functional Communication Profile scale will be applied – Checklist, which is a list of communicative functions performed by children. Applied in the form of an interview, it indicates which of the 20 functions identified in the Functional Communication Profile the child uses, from the evaluator's point of view, taking into account the occurrence and the communicative means used. being applied before the beginning and for 2 more times throughout the treatment.;The Questionnaire to assess the quality of life of caregivers of children and adolescents with Autism spectrum disorder and Sociodemographic Profile will be applied, containing ten sociodemographic questions followed by 28 questions about quality of life. This questionnaire was developed and validated for the Brazilian population and uses a five-point Likert scale, with a total of 28 questions about the quality of life of caregivers of children and adolescents with Autism spectrum disorder. being applied before the beginning and for 2 more times throughout the treatment.;A puncture will be made to remove a drop of blood and immediate analysis in dark field microscopy with the collection of images referring to the behavior of erythrocytes | — |
Countries
Brazil
Contacts
Public ContactDaniel Martins
Universidade do Sul de Santa Catarina
Outcome results
None listed