Biomarkers Research in Anxiety for Validation and Efficacy

Recruitment & Eligibility

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.

Study & Design

Arm && Interventions

Group	Intervention	Description
Intervention Group	Being Brave	Being Brave

Primary Outcome Measures

Name	Time	Method
Spence Preschool Anxiety Scale (SPAS) or Spence Anxiety Scale (SCAS) Parent Report	At baseline enrollment visit and post intervention approximately 20 weeks later	Parents of children ages 3 to 5 will complete the SPAS and parents of 6 year old children will complete the SCAS. These are questionnaires designed to assess the severity of anxiety symptoms in preschool-aged and school-aged children. Scores range from 0-136 with higher scores indicating greater anxiety.

Secondary Outcome Measures

Name	Time	Method
Behavior Assessment System for Children (BASC-3)	At baseline enrollment visit and post intervention approximately 20 weeks later	The BASC-3 measures adaptive and problem behaviors in the community and home setting. It has a strong foundation in theory and research. Scores range from 20-120 with higher scores indicating greater anxiety.
Pediatric Anxiety Rating Scale (PARS)	At baseline enrollment visit and post intervention approximately 20 weeks later	The PARS is a checklist which the independent evaluating clinician completes based upon parent interview. The measure is designed to assess the severity of anxiety symptoms associated with social phobia, separation anxiety disorder, and generalized anxiety disorder. Scores range from 0-25 with higher scores indicating greater anxiety.
Clinical Global Impression of Anxiety (CGI-A) Interview	At baseline enrollment visit and post intervention approximately 20 weeks later	The CGI-A assesses severity and improvement of anxiety using a 7-point Likert scale (from "very much better" to "very much worse"). Based on information collected from the KSADSE, PARS, and Spence, the clinician will rate the global severity of the child's global anxiety and of each individual anxiety disorder. Scores range from 0-8 with higher scores indicating greater anxiety.

Recruitment & Eligibility