Status:
RECRUITING
Biomarkers Research in Anxiety for Validation and Efficacy
Lead Sponsor:
Boston Children's Hospital
Conditions:
Autism
Autism Spectrum Disorder
Eligibility:
All Genders
3-6 years
Phase:
NA
Brief 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 re...
Detailed Description
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 re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06221176
Start Date
April 2 2024
End Date
August 1 2025
Last Update
March 12 2025
Active Locations (1)
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1
Boston Children's Hospital, Two Brookline Place
Brookline, Massachusetts, United States, 02445