Biomarkers Research in Anxiety for Validation and Efficacy

Part of paid clinical trials in Brookline, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT06221176
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
3 Years - 6 Years
Healthy Volunteers
Not accepted

Interventions

  • Being Brave — BEHAVIORAL
    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.

Study Details

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).

Key Dates

Start date
Apr 2, 2024
Status verified
Apr 2026
Primary completion
Jun 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Intervention Group
    Being Brave

Primary Outcome Measure

Spence Preschool Anxiety Scale (SPAS) or Spence Anxiety Scale (SCAS) Parent Report [ Time Frame: At baseline enrollment visit and post intervention approximately 20 weeks later ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's Hospital, Two Brookline PlaceBrooklineMassachusetts02445
Susan Faja, PhD
[email protected]
617-919-4486

Find similar trials in Brookline, MA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Boston Children's Hospital, Two Brookline Place· Brookline, MA

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