the Effect of Formulation on Anxiety in Autist Childre A Randomized Controlled Trial Assesses Spirulina Syrup Plus Risperidone in Children With Non-idiopathic Autism. Anxiety is Measured Using the SCAS (Parent Version) Via Daily Online Surveys for One Week and Throughout a 3-month Follow-up Period.

The aim of this study is to evaluate the effect of a Spirulina syrup formulation on reducing anxiety in children with non-idiopathic autism. Participants are referred to a private clinic and assessed by a pediatric neurology subspecialist to confirm the diagnosis. Informed consent is obtained from the parents. Patients are randomly assigned to two groups. The intervention group receives standard treatment (Risperidone tablets) plus Spirulina syrup, while the control group receives Risperidone plus a placebo. Anxiety is measured using the parent version of the Spence Children's Anxiety Scale (SCAS), which includes 38 items rated on a 4-point Likert scale. The questionnaire is administered online via the Porsline platform, and links are sent nightly via social media starting before treatment and continuing daily for one week after treatment initiation, then regularly over a 3-month follow-up period. Data will be analyzed using SPSS version 16. The SCAS consists of six subscales: separation anxiety, social anxiety, phobia, generalized anxiety, panic, and obsessive-compulsive symptoms.

NCT Number	NCT07060872
Lead Sponsor	Shahid Sadoughi University of Medical Sciences and Health Services
Conditions	Age 3 to 7 Years, Mild Autism Spectrum, no Other Illness or Disorder
Enrollment	82 participants
Start Date	2025-07-07
Primary Completion	2025-09-15 (estimated)
Study Completion	2025-10-01 (estimated)
Updated on ClinicalTrials.gov	2025-07-11