Biomarkers Research in Anxiety for Validation and Efficacy

Translational Biomarkers and Therapeutic Development for Very Young Children Diagnosed With Autism Spectrum Disorder and Co-occurring Anxiety

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).

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).

The main questions the study aims to answer are:

• To evaluate the stability of each potential biomarker over a 3-4-week retest period. The biomarkers are hypothesized to have adequate stability (ICC: > .5) in the absence of intervention.
• To determine which baseline biomarker scores predict response to a manualized cognitive behavioral therapy (CBT) program for treating anxiety, Being Brave.
• To determine which biomarkers are sensitive to treatment response.

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 (<36 weeks) or low birth weight (<2500 gms)
• Known genetic or medical disorders (e.g., Fragile X), or injuries (e.g., stroke) with implications for the nervous system or that require regular psychoactive medication that alter EEG/RSA/EDR signal (e.g., anti-convulsants)
• Significant sensory or motor impairment (e.g., blindness)
• Major physical abnormalities
• Exposure to environmental factors that could contribute to neurocognitive delays (significant alcohol exposure in utero, extreme environmental deprivation)
• Previous CBT for anxiety
• Presence of conduct or oppositional defiant disorder or ADHD so severe as to interfere with the child's ability to take part in treatment
• Presence of a primary presenting problem for which the intervention would be inappropriate (e.g., obsessive-compulsive disorder, severe mood disorder, suicidality)
• Psychotic symptoms in the child or parents
• Parent/caregiver who is not fluent in English or English is spoken in the home less than half of the time.