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