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NCT06221176Completed

Biomarkers Research in Anxiety for Validation and Efficacy

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

Source: ClinicalTrials.gov · Last updated 16 Jul 2026

Brief summary (registry, in English)

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).

Status (registry)
Completed
Study type
Interventional
Enrollment
30 (actual)
First submitted
2 Jan 2024
Start date
2 Apr 2024
Primary completion date
1 Jun 2026
Lead sponsor
Boston Children's Hospital
Diseases
Autism
NCT number
NCT06221176

What you commit to

  • Study type: Interventional
  • Participants enrolled: 30
  • From 2 Apr 2024 to the primary completion date, 1 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous CBT for anxiety

Other illness

  • Presence of seizures
  • 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)
  • 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)

Other

  • Premature birth (\<36 weeks) or low birth weight (\<2500 gms)
  • Major physical abnormalities
  • Exposure to environmental factors that could contribute to neurocognitive delays (significant alcohol exposure in utero, extreme environmental deprivation)
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 3 years to 6 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Boston Children's Hospital, Two Brookline Place
Coordinator of this site? Confirm its status
BrooklineUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.