Biomarkers Research in Anxiety for Validation and Efficacy
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).
Conditions:
🦠 Autism 🦠 Autism Spectrum Disorder
🗓️ Study Start (Actual) 2 April 2024
🗓️ Primary Completion (Estimated) 1 March 2025
✅ Study Completion (Estimated) 1 March 2025
👥 Enrollment (Estimated) 25
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Brookline, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Age between 3;0 and 6;11 years old
    • * A diagnosis of autism spectrum disorder using DSM-5 diagnostic criteria
    • * A diagnosis of anxiety disorder using DSM-5 diagnostic criteria
    • * Use of fluent 2-3 word phrases or fluent speech (i.e., Module 2 or 3 for ADOS-2)
    • * Cognitive ability (either verbal or non-verbal IQ) \> 80 using the DAS-2
    • * A parent/guardian who is willing/able to participate and respond to interviews/surveys in English and willing/able to participate in Being Brave parent training in English and support homework activities.

    Exclusion Criteria:

    • * Presence of seizures
    • * Premature birth (\<36 weeks) or low birth weight (\<2500 gms)
    • * Known genetic or medical disorders (e.g., Fragile X), or injuries (e.g., stroke) with implications for the nervous system or that require regular psychoactive medication that alter EEG/RSA/EDR signal (e.g., anti-convulsants)
    • * Significant sensory or motor impairment (e.g., blindness)
    • * Major physical abnormalities
    • * Exposure to environmental factors that could contribute to neurocognitive delays (significant alcohol exposure in utero, extreme environmental deprivation)
    • * Previous CBT for anxiety
    • * Presence of conduct or oppositional defiant disorder or ADHD so severe as to interfere with the child's ability to take part in treatment
    • * Presence of a primary presenting problem for which the intervention would be inappropriate (e.g., obsessive-compulsive disorder, severe mood disorder, suicidality)
    • * Psychotic symptoms in the child or parents
    • * Parent/caregiver who is not fluent in English or English is spoken in the home less than half of the time.
Ages Eligible for Study: 3 Years to 6 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 January 2024
  • First Submitted that Met QC Criteria 14 January 2024
  • First Posted 24 January 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 April 2024
  • Last Update Posted 10 April 2024
  • Last Verified April 2024