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Biomarkers Research in Anxiety for Validation and Efficacy
Sponsor: Boston Children's Hospital
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).
Official title: Translational Biomarkers and Therapeutic Development for Very Young Children Diagnosed with Autism Spectrum Disorder and Co-occurring Anxiety
Key Details
Gender
All
Age Range
3 Years - 6 Years
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2024-04-02
Completion Date
2025-08-01
Last Updated
2025-03-12
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Boston Children's Hospital, Two Brookline Place
Brookline, Massachusetts, United States