Childhood autism
Conditions
Interventions
This is a randomized, single-blind, two-arm controlled clinical trial. The minimum sample size will be 60 individuals, with 30 participants per group, totaling 2 groups. Participants will be randomly
however, they will receive LED at a non-therapeutic intensity. After the four weeks of treatment, all subjects will be reassessed with the same tests as the baseline assessment.
Sponsors
Sociedade de Educação Superior e Cultura Brasil S.A.
Sociedade de Educação Superior e Cultura Brasil S.A.
Eligibility
Age
7 Years to 10 Years
Inclusion criteria
Inclusion criteria: Children diagnosed with mild Autism Spectrum Disorder (ASD); both sexes; between the ages of 7 and 10; residing in the greater Florianópolis region
Exclusion criteria
Exclusion criteria: Children undergoing treatment with psychotropic medications; diagnosed with another neurological dysfunction; or who have contraindications to laser treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim is to assess behaviors associated with autism spectrum disorder (ASD) throughout the treatment period using the Autism Behavior Checklist (ABC), which evaluates ASD-related behaviors based on five scales: I- Irritability and agitation; II- Lethargy and social withdrawal; III- Stereotypy; IV- Hyperactivity and disobedience; V- Inappropriate speech. Each item on the test is scored from 1 to 4. This test has been used as a responsive measure to evaluate the effects of medication and psychosocial treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The disease classification is expected to be monitored throughout the 4 weeks of treatment using the Clinical Global Impressions Severity (CGI-S) scale, which rates the severity of the disease from 1 to 7, with 1 being normal or not ill, and 7 being extremely severe mental illness.;The improvement/change in children during the treatment period is expected to be monitored using the Clinical Global Impression Change (CGI-C) scale, which is also classified on a 7-point scale, where 1 means the individual is much better, and 7 means much worse.;It is expected that improvements in the severity of autism spectrum disorder symptoms in the children of the study will be observed using the Childhood Autism Rating Scale (CARS), a scale consisting of 15 items based on emotional responses, relationships, adaptation, environmental changes, visual and anxiety responses, nonverbal and brief communication. Based on these responses, ASD symptoms will be assessed, allowing for an evaluation of severity, where scores above 30 points suggest ASD, scores from 30 to 36 are divided between mild and moderate, while scores above 36 indicate severe. After the laser therapy intervention, the CARS score will be repeated to assess whether the treatment was beneficial; a total CARS score between 5 and 10 points indicates treatment effectiveness, and a score of 5 points or less indicates ineffectiveness.;Improvements in cognitive performance are expected in children with autism spectrum disorder, based on the Wechsler Intelligence Scale for Children (WISC-IV), which will be administered by a psychologist to assess the cognitive performance of children with ASD. It consists of 15 subtests, divided into four indices, that evaluate: Verbal Comprehension (VC), Perceptual Reasoning (PR), Working Memory (WM), and Processing Speed ??(PS).;The aim is to monitor the evolution of balance in children with autism spectrum disorder. To assess the individuals' orthostatic balance, a computerized baropodome | — |
Countries
Brazil
Contacts
Public ContactDaniel Martins
Universidade do Sul de Santa Catarina
Outcome results
None listed