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).

Conditions

  • Autism
  • Autism Spectrum Disorder

Recruitment Status

RECRUITING

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 response (i.e., change). 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.

Eligibility Criteria

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.

Phase

NA

Gender

ALL

Min Age

3 Years

Max Age

6 Years

Download Date

2025-03-12

Principal Investigator

Susan Faja

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

Primary Contact Information

Contact Info
Susan Faja, PhD
susan.faja@childrens.harvard.edu

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

Intervention

Intervention Type

BEHAVIORAL

Intervention Name

Being Brave

Contact

For more information and to contact the study team:

Biomarkers Research in Anxiety for Validation and Efficacy NCT06221176 Susan Faja, PhD susan.faja@childrens.harvard.edu