Actively Recruiting
Biomarkers Research in Anxiety for Validation and Efficacy
Led by Boston Children's Hospital · Updated on 2026-04-23
25
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Biomarkers Research in Anxiety for Validation and Efficacy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 3;0 and 6;11 years old
- Diagnosis of autism spectrum disorder using DSM-5 criteria
- Diagnosis of anxiety disorder using DSM-5 criteria
- Use of fluent 2-3 word phrases or fluent speech (Module 2 or 3 for ADOS-2)
- Cognitive ability (verbal or non-verbal IQ) greater than 80 using DAS-2
- Parent/guardian willing and able to participate in English and support homework during Being Brave parent training
You will not qualify if you...
- Presence of seizures
- Premature birth (less than 36 weeks) or low birth weight (less than 2500 grams)
- Known genetic or medical disorders affecting the nervous system or requiring regular psychoactive medication that alters EEG/RSA/EDR signals
- Significant sensory or motor impairments such as blindness
- Major physical abnormalities
- Exposure to environmental factors contributing to neurocognitive delays (e.g., significant alcohol exposure in utero, extreme deprivation)
- Previous cognitive behavioral therapy for anxiety
- Presence of conduct disorder, oppositional defiant disorder, or severe ADHD interfering with treatment participation
- Primary presenting problems inappropriate for this intervention (e.g., obsessive-compulsive disorder, severe mood disorder, suicidality)
- Psychotic symptoms in the child or parents
- Parent/caregiver not fluent in English or English spoken less than half the time at home
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital, Two Brookline Place
Brookline, Massachusetts, United States, 02445
Actively Recruiting
Research Team
S
Susan C Faja, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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