NCT06221176

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 6 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Autism
• Autism Spectrum Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Being Brave	Being Brave is a manualized cognitive-behavioral (CBT) intervention and includes several features that are well-aligned with the needs of autistic children: (1) an intensive parent component; (2) use of visual aids to lay out coping plans and exposure hierarchies, psychoeducation about recognizing fear and anxiety, and scripted language for coping; (3) repeated practice of well-rehearsed coping plans for novel or challenging situations; and (4) exposure exercises for social anxiety and practice of basic social skills. The intervention includes 16 weekly sessions (1 hour each). Delivery of Being Brave is flexible to allow for additional or less practice or exposure opportunities.

Timeline

• Start date: 2024-04-02
• Primary completion: 2025-06-01
• Completion: 2025-08-01
• First posted: 2024-01-24
• Last updated: 2025-03-12

Locations

1 site across 1 country: United States