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Biomarkers Research in Anxiety for Validation and Efficacy

NCT06221176 · Boston Children's Hospital
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Official title
Translational Biomarkers and Therapeutic Development for Very Young Children Diagnosed With Autism Spectrum Disorder and Co-occurring Anxiety
About this study
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.
Study design
Enrollment target: 25 participants
Allocation: na
Masking: none
Age groups: child
Timeline
Starts: 2024-04-02
Estimated completion: 2026-08-01
Last updated: 2026-04-23
Interventions
Behavioral: Being Brave
Primary outcomes
  • Spence Preschool Anxiety Scale (SPAS) or Spence Anxiety Scale (SCAS) Parent Report (At baseline enrollment visit and post intervention approximately 20 weeks later)
Sponsor
Boston Children's Hospital · other
Contacts & investigators
ContactSusan C Faja, PhD · contact · susan.faja@childrens.harvard.edu · 16179194486
All locations (1)
Boston Children's Hospital, Two Brookline PlaceRecruiting
Brookline, Massachusetts, United States
Biomarkers Research in Anxiety for Validation and Efficacy · TrialPath