Biomarkers Research in Anxiety for Validation and Efficacy (BRAVE)

Boston Children's Hospital

Status

Enrolling

Conditions

Autism Spectrum Disorder

Autism

Treatments

Behavioral: Being Brave

Study type

Interventional

Funder types

Other

Identifiers

NCT06221176

P00046792

Details and patient eligibility

About

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).

Full description

The main questions the study aims to answer are:

To evaluate the stability of each potential biomarker over a 3-4-week retest period. The biomarkers are hypothesized to have adequate stability (ICC: > .5) in the absence of intervention.
To determine which baseline biomarker scores predict response to a manualized cognitive behavioral therapy (CBT) program for treating anxiety, Being Brave.
To determine which biomarkers are sensitive to treatment response.

Enrollment

25 estimated patients

Sex

All

Ages

3 to 6 years old

Volunteers

No Healthy Volunteers

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.