RecruitingNot ApplicableNCT06221176

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


Sponsor

Boston Children's Hospital

Enrollment

25 participants

Start Date

Apr 2, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 3 YearsMax Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying biological markers (biomarkers) — including brain activity, heart rate, and skin electrical signals — in young children aged 3 to 7 who have both autism spectrum disorder (ASD) and anxiety, to better understand how anxiety works in this population and whether a specific therapy (Being Brave) is effective and can be tracked biologically. **You may be eligible if...** - Your child is aged 3 years to 6 years 11 months - Your child has a confirmed diagnosis of both autism spectrum disorder and an anxiety disorder (per DSM-5) - Your child uses at least 2–3 word phrases when speaking - Your child has an IQ (verbal or non-verbal) above 80 - You (the parent/guardian) are English-speaking, willing to participate in the parent training component, and able to support homework activities **You may NOT be eligible if...** - Your child has a seizure disorder - Your child was born prematurely (before 36 weeks) or had a low birth weight - Your child has a known genetic condition (e.g., Fragile X syndrome) or neurological injury - Your child has previously received cognitive behavioral therapy (CBT) for anxiety - Your child has severe ADHD or oppositional behavior that would interfere with treatment - You as a parent are not fluent in English or English is spoken less than half the time at home Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALBeing 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

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NCT06221176


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