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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
25
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.
Boston Children's Hospital, Two Brookline Place
Brookline, Massachusetts, United States
RECRUITINGSpence Preschool Anxiety Scale (SPAS) or Spence Anxiety Scale (SCAS) Parent Report
Parents of children ages 3 to 5 will complete the SPAS and parents of 6 year old children will complete the SCAS. These are questionnaires designed to assess the severity of anxiety symptoms in preschool-aged and school-aged children. Scores range from 0-136 with higher scores indicating greater anxiety.
Time frame: At baseline enrollment visit and post intervention approximately 20 weeks later
Behavior Assessment System for Children (BASC-3)
The BASC-3 measures adaptive and problem behaviors in the community and home setting. It has a strong foundation in theory and research. Scores range from 20-120 with higher scores indicating greater anxiety.
Time frame: At baseline enrollment visit and post intervention approximately 20 weeks later
Pediatric Anxiety Rating Scale (PARS)
The PARS is a checklist which the independent evaluating clinician completes based upon parent interview. The measure is designed to assess the severity of anxiety symptoms associated with social phobia, separation anxiety disorder, and generalized anxiety disorder. Scores range from 0-25 with higher scores indicating greater anxiety.
Time frame: At baseline enrollment visit and post intervention approximately 20 weeks later
Clinical Global Impression of Anxiety (CGI-A) Interview
The CGI-A assesses severity and improvement of anxiety using a 7-point Likert scale (from "very much better" to "very much worse"). Based on information collected from the KSADSE, PARS, and Spence, the clinician will rate the global severity of the child's global anxiety and of each individual anxiety disorder. Scores range from 0-8 with higher scores indicating greater anxiety.
Time frame: At baseline enrollment visit and post intervention approximately 20 weeks later
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