Autism Spectrum Disorder
Conditions
Interventions
Randomized, placebo-controlled, double-blind clinical trial. Randomization will be performed considering stratification according to the severity of autism spectrum disorder, according to the Childhoo
E02.331.750
Sponsors
Universidade Evangélica de Goiás
Follow Kids - Clinica de Neuro Reabilitação Infantil
Eligibility
Age
5 Years to 8 Years
Inclusion criteria
Inclusion criteria: Diagnosis of autism spectrum disorder confirmed through clinical examination; have a standardized neurobehavioral assessment that confirms and categorizes the severity of autism spectrum disorder; children levels I, II and III according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-V); age between five and nine years of age of both sexes; children who demonstrate sufficient response to understand simple verbal commands; no medication changes at least six months before the start of the study and during its execution; statement of informed consent signed by a legal guardian; statement of informed assent signed by the participant
Exclusion criteria
Exclusion criteria: Children that having been submitted to surgical procedures or neurolytic block in the 12 months prior to the onset of the training sessions; orthopedic deformities with indication for surgery; epilepsy; metal implants in skull or hearing aids; intellectual disorder that would limit the execution of the intellectual activities proposed in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a decrease in sensory integration dysfunctions, assessed by the Ayres Sensory Integration Assessment with an average reduction of 10% in the score after the interventions. Data collected one week before the intervention and one and four weeks after the intervention;It is expected to find a reduction in the symptoms of vestibular dysfunction, assessed by the vestibulo-ocular reflex and nystagmus, with no observation of the altered reflex and nystagmus after the interventions. Data collected one week before the intervention and one and four weeks after the intervention;It is expected to find an increase in functional performance with increased independence in daily activities, demonstrated by an increase of 5 points in the Pediatric Evaluation of Disability Inventor after the interventions. Data collected one week before the intervention and one and four weeks after the intervention;It is expected to find an increase in participation, assessed by the Participation and Environment Measure for Children and Youth demonstrated by a 5% increase in scores after the interventions. Data collected one week before the intervention and one and four weeks after the intervention;It is expected that no moderate or severe adverse effects will be found during the intervention period, as assessed by a standardized questionnaire that quantifies the perception and intensity of symptoms, demonstrated by the non-reporting of such effects. Data collected one week before the intervention and one and four weeks after the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find a reduction in the severity of autistic symptoms observed by the child's guardians after the interventions, assessed by the Childhood Autism Rating Scale. Data collected one week before the intervention and one and four weeks after the intervention | — |
Countries
Brazil
Contacts
Public ContactLuanda Collange
Universidade Evangélica de Goiás
Outcome results
None listed