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
Boston Children's Hospital
25 participants
Apr 2, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria6
- 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 Criteria11
- 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.
Interventions
Being Brave is a manualized cognitive-behavioral (CBT) intervention and includes several features that are well-aligned with the needs of autistic children: (1) an intensive parent component; (2) use of visual aids to lay out coping plans and exposure hierarchies, psychoeducation about recognizing fear and anxiety, and scripted language for coping; (3) repeated practice of well-rehearsed coping plans for novel or challenging situations; and (4) exposure exercises for social anxiety and practice of basic social skills. The intervention includes 16 weekly sessions (1 hour each). Delivery of Being Brave is flexible to allow for additional or less practice or exposure opportunities.
Locations(1)
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NCT06221176