At a glance
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Specifying and Treating the Anxiety Phenotype in Autism Spectrum Disorder
In Brief
A Phase 2 clinical trial evaluating Sertraline, CBT/BIACA, and 1 other intervention for Autism Spectrum Disorder and Anxiety. Completed, enrolled 68 participants across 1 site.
Detailed Summary
The Specifying and Treating the Anxiety Phenotype in Autism Spectrum Disorder (STAAR) study aims to better characterize the sub-group of children and preadolescents with ASD that exhibit clinically significant anxiety by conducting a 16-week randomized comparative treatment trial of the Behavioral Intervention for Anxiety in Children with Autism (BIACA), the medication sertraline, and placebo in youth with ASD ages 8-14 years old. The study involves 2-3 half day telehealth visits for behavioral and medical assessments, 1-2 lab visits for safety testing, and 1-2 optional fMRI visits. The study provides 16-weeks of anxiety treatment involving weekly BIACA therapy either in-person or through telehealth, or medical check-up visits either at the UC Davis MIND Institute or via telehealth. After study completion a 3 month follow up call is conducted and participants in the placebo group are given the option to participate in an additional study phase with the study treatment of their choice. Study participation can be done remotely through the use of telehealth and local labs, visits to the UC Davis MIND Institute are not required for most participants.
Study Details
Timeline
Interventions
Participants start at 12.5 mg and are increased by 12.5/day every two weeks for 14-16 weeks based on their tolerability to the medication. Dosing is capped at 125mg/day.
Participants receive 16 weeks of BIACA therapy.
Participants are given a placebo capsule with an administration schedule matching that of the sertraline subjects.