Biomarkers Research in Anxiety for Validation and Efficacy

Completed · Not applicable

Conditions studied: Autism, Autism Spectrum Disorder

In brief

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).

Key facts

Study ID

NCT06221176

Run by

Boston Children's Hospital

People needed

30

Starts

2024-04-02

Expected to finish

2026-06-01

Last updated by the study team

2026-07-16

Who can join

Age: 3 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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