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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Being Brave |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Being Brave | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Spence 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. | At baseline enrollment visit and post intervention approximately 20 weeks later |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline enrollment visit and post intervention approximately 20 weeks later |
| Measure | Description | Time Frame |
|---|---|---|
| Coping Questionnaire (CQ) | To assess changes in a child's ability to manage specific anxiety-provoking situations, parents rate up to six specific anxiety-provoking situations for their child. Scores range from 6-42 with lower scores indicating lower ability to cope with anxiety. | At baseline enrollment visit and post intervention approximately 20 weeks later |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susan C Faja, PhD | Contact | 16179194486 | susan.faja@childrens.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital, Two Brookline Place | Recruiting | Brookline | Massachusetts | 02445 | United States |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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|
| 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. |
| 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. | At baseline enrollment visit and post intervention approximately 20 weeks later |
| Family Life Impairment Scale (FLIS) | To assess the extent to which child behavior limits participation in activities typical of families with young children, parents will complete this measure. Scores range from 0-38 with higher scores indicating greater impact of child behavior on family functioning. | At baseline enrollment visit and post intervention approximately 20 weeks later |
| Resting EEG Alpha Asymmetry | Continuous EEG will be collected while children watch non-social videos for a 4 minute baseline period and again after a brief challenge task (working memory, conversation about feelings). The dependent variable will be EEG alpha power asymmetry (i.e., difference in alpha power between the left and right frontal recording sites) | At baseline, 3-4 weeks later, and at post (approximately 20 weeks later) |
| Late Positive Potential mean Event-related Potentials (ERPs) Amplitude | ERPs will be collected while children view digitized and standardized photos of neutral, fearful, angry, and happy expressions (50 per condition). Each trial will consist of a 100ms baseline, 500ms face stimulus, 1200ms post-stimulus period, and variable inter-trial interval of 500-1000ms. The dependent variable will be the ERP mean amplitude at the late positive potential measured between 700-1200ms over anterior leads. | At baseline, 3-4 weeks later, and at post (approximately 20 weeks later) |
| Mean Electrodermal Response (EDR) Amplitude | EDR will be collected during a task includes acquisition trials that pair a conditioned stimulus (CS+; a geometric shape) with an aversive tone (i.e., unconditioned stimulus). The second conditioned stimulus (CS-; a different geometric shape) is presented alone. The CS+ and CS- are counterbalanced across children and will be unique at each time point. The Pavlovian Conditioning and Extinction Task will be conducted to measure the rate of EDR habituation during the extinction period. In addition, EDR levels will be explored during a series of challenges in different domains paired with non-challenging tasks that control for the psychomotor demands of the challenge task. | At baseline, 3-4 weeks later, and at post (approximately 20 weeks later) |
| Respiratory sinus arrhythmia (RSA) reactivity | RSA will be collected during a validated protocol for assessing autonomic nervous system reactivity in children ages 3 to 6. The protocol includes a series of challenges in different domains paired with non-challenging tasks that control for the psychomotor demands of the challenge task. RSA will also be explored during the extinction period of a conditioning task. | At baseline, 3-4 weeks later, and at post (approximately 20 weeks later) |