Biomarkers Research in Anxiety for Validation and Efficacy

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).

Conditions

Autism, Autism Spectrum Disorder

Study Overview

Study Details

Study overview

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).

Translational Biomarkers and Therapeutic Development for Very Young Children Diagnosed With Autism Spectrum Disorder and Co-occurring Anxiety

Biomarkers Research in Anxiety for Validation and Efficacy

Condition
Autism
Intervention / Treatment

-

Contacts and Locations

Brookline

Boston Children's Hospital, Two Brookline Place, Brookline, Massachusetts, United States, 02445

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Children's Hospital,

Study Record Dates

2025-03-01