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Completed NCT06221176

Biomarkers Research in Anxiety for Validation and Efficacy

Conditions: Autism, Autism Spectrum Disorder

Sex: All
Ages: 3 Years – 6 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Boston Children's Hospital

Location: Boston Children's Hospital, Two Brookline Place Brookline Massachusetts

Summary

A within-subjects design will be used for this preliminary investigation of four biomarkers across two contexts of use: prediction of treatment response (i.e., stratification) and quantification of response (i.e., change).

Eligibility Criteria

Inclusion Criteria: * Age between 3;0 and 6;11 years old * A diagnosis of autism spectrum disorder using DSM-5 diagnostic criteria * A diagnosis of anxiety disorder using DSM-5 diagnostic criteria * Use of fluent 2-3 word phrases or fluent speech (i.e., Module 2 or 3 for ADOS-2) * Cognitive ability (either verbal or non-verbal IQ) \> 80 using the DAS-2 * A parent/guardian who is willing/able to participate and respond to interviews/surveys in English and willing/able to participate in Being Brave parent training in English and support homework activities. Exclusion Criteria: * Presence of seizures * Premature birth (\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06221176). StuddyBuddy aggregates publicly available trial information.