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Biomarkers Research in Anxiety for Validation and Efficacy

RECRUITINGN/ASponsored by Boston Children's Hospital
Actively Recruiting
PhaseN/A
SponsorBoston Children's Hospital
Started2024-04-02
Est. completion2025-06-01
Eligibility
Age3 Years – 6 Years
Healthy vol.Accepted
Locations1 site

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

Age: 3 Years – 6 YearsHealthy volunteers accepted
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.

Conditions3

AnxietyAutismAutism Spectrum Disorder

Locations1 site

Boston Children's Hospital, Two Brookline Place
Brookline, Massachusetts, 02445
Susan Faja, PhD16179194486susan.faja@childrens.harvard.edu

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