Biomarkers Research in Anxiety for Validation and Efficacy — BRAVE  

Autism Spectrum Disorder Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

• NCT number: NCT06221176
• Study type: Interventional
• Source: Boston Children's Hospital
• Contact: Susan C Faja, PhD
• Phone: 16179194486
• Email: susan.faja@childrens.harvard.edu
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2024
• Completion date: March 1, 2025