Specifying and Treating Anxiety in Autism Research
Status:
Recruiting
Trial end date:
2022-09-14
Target enrollment:
Participant gender:
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.