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

What this Trial Is About

Researchers are conducting a study to explore four potential biomarkers in young children aged 3 to 6 years diagnosed with autism spectrum disorder and co-occurring anxiety. The study aims to evaluate how stable these biomarkers are over a 3-4 week period without treatment, to see which biomarkers can predict how well a child will respond to a specific cognitive behavioral therapy (CBT) program called Being Brave, and to measure changes in these biomarkers after treatment. Participants will receive the Being Brave intervention, a structured CBT program tailored for autistic children with anxiety. This program includes 16 weekly one-hour sessions focusing on parent involvement, visual aids for coping plans, psychoeducation about anxiety and fear, practice of coping strategies, and exposure exercises to address social anxiety. The program is flexible to allow different levels of practice as needed. During the study, children and their parents will complete assessments at the start and approximately 20 weeks later after finishing the intervention. These assessments include parent-reported anxiety scales and clinical interviews to measure anxiety levels and overall improvement. The study will monitor treatment response through these measures and biomarker stability. Parents are also involved in training and supporting their child’s practice of coping skills throughout the treatment period.

Biomarkers Research in Anxiety for Validation and Efficacy