Clinical trial NCT06221176: Biomarkers Research in Anxiety for Validation and Efficacy
Official title: Translational Biomarkers and Therapeutic Development for Very Young Children Diagnosed with Autism Spectrum Disorder and Co-occurring Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 25
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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).

Detailed 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).

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.

Primary outcomes:
measure: Spence Preschool Anxiety Scale (SPAS) or Spence Anxiety Scale (SCAS) Parent Report
timeFrame: At baseline enrollment visit and post intervention approximately 20 weeks later
Secondary outcomes:
measure: Behavior Assessment System for Children (BASC-3)
timeFrame: At baseline enrollment visit and post intervention approximately 20 weeks later
measure: Pediatric Anxiety Rating Scale (PARS)
timeFrame: At baseline enrollment visit and post intervention approximately 20 weeks later
measure: Clinical Global Impression of Anxiety (CGI-A) Interview
timeFrame: At baseline enrollment visit and post intervention approximately 20 weeks later
Other outcomes:
measure: Coping Questionnaire (CQ)
timeFrame: At baseline enrollment visit and post intervention approximately 20 weeks later
measure: Family Life Impairment Scale (FLIS)
timeFrame: At baseline enrollment visit and post intervention approximately 20 weeks later
measure: Resting EEG Alpha Asymmetry
timeFrame: At baseline, 3-4 weeks later, and at post (approximately 20 weeks later)
measure: Late Positive Potential mean Event-related Potentials (ERPs) Amplitude
timeFrame: At baseline, 3-4 weeks later, and at post (approximately 20 weeks later)
measure: Mean Electrodermal Response (EDR) Amplitude
timeFrame: At baseline, 3-4 weeks later, and at post (approximately 20 weeks later)
measure: Respiratory sinus arrhythmia (RSA) reactivity
timeFrame: At baseline, 3-4 weeks later, and at post (approximately 20 weeks later)
Locations:
city: Brookline
country: United States
facility: Boston Children's Hospital, Two Brookline Place
state: Massachusetts
Study officials:
References: