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RECRUITING
NCT06221176
NA

Biomarkers Research in Anxiety for Validation and Efficacy

Sponsor: Boston Children's Hospital

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Boston Children's Hospital, Two Brookline Place

Brookline, Massachusetts, United States