Actively Recruiting

Phase Not Applicable
Age: 3Years - 6Years
All Genders
NCT06221176

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

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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

Age: 3Years - 6Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Boston Children's Hospital, Two Brookline Place

Brookline, Massachusetts, United States, 02445

Actively Recruiting

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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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