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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-AR230226 | Other Grant/Funding Number | DoD Congressionally-Directed Medical Research Program |
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| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
| Drexel University | OTHER |
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The goal of this clinical trial is to investigate neural constructs related to anxiety symptoms in response to Facing Your Fears (FYF) treatment in autistic participants with co-occurring anxiety.
Researchers will compare participants receiving immediate FYF intervention to those in the waitlist control group (receiving treatment as usual) to see if there are differences in neural constructs and anxiety symptom changes over the study period.
Participants will:
Aims of the study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Waitlist-Control Condition | No Intervention | Waitlist Control (WC) with Treatment-as-Usual (TAU). Participants in the WC arm will continue in their usual services and will be provided with referrals if needed. No specific treatment recommendations will be given.For ethical reasons, after completing the TAU waitlist period, families will be provided with an opportunity to participate in the FYF intervention. | |
| Treatment Condition: Facing Your Fears (FYF) Group | Experimental | The group consists of 4-6 families who will meet for 90-minute weekly sessions for 12-14 weeks. The sessions will focus on psychoeducation and implementing CBT techniques to help autistic youth and their caregivers "face their fears" and tackle their anxiety. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Facing Your Fears (FYF) Intervention: A CBT Focused Group Treatment for Autistic Youth with Anxiety | Behavioral | FYF is an outpatient, multi-family, evidence-based CBT group treatment for children and adolescents ages 8-14 with average intellectual abilities, and a primary co-occurring anxiety diagnosis (social, generalized, separation anxiety, or specific phobia). |
| Measure | Description | Time Frame |
|---|---|---|
| The Screen for Child Anxiety and Related Disorders (SCARED-P/C) | The Screen for Child Anxiety and Related Disorders - Parent/Child versions (SCARED-P/C) is comprised of five anxiety subscales, including panic, generalized anxiety, separation anxiety, and school avoidance symptoms, and a total anxiety subscale. The SCARED-P and SCARED-C each include 41 items designed to evaluate a child's recent anxiety symptoms. Participants rate their responses on a 3-point Likert scale: 0 (Not True or Hardly Ever True), 1 (Somewhat or Sometimes True), and 2 (Very True or Often True). A total score of 25 or higher is considered indicative of clinically significant anxiety. The SCARED has shown good psychometric properties across autistic and non-autistic samples. It has shown evidence for treatment sensitivity in previous FYF trials, and will be used as a primary outcome measure in this study as well. | Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session) |
| Anxiety Scale for Children-Autism Spectrum Disorder Scale (ASC-ASD) | The Anxiety Scale for Children-Autism Spectrum Disorder Scale (ASC-ASD) is a self- and parent-report measure developed to assess separation anxiety, uncertainty, performance anxiety, and anxious arousal dimensionally in the autistic population. It consists of 25-items (scored 0-3) with higher scores indicating higher anxiety levels.. | Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session) |
| Parent Rated Anxiety Scale for Autism Spectrum Disorder (PRAS-ASD) | It consists of 25-items (scored 0-3) with higher scores indicating higher anxiety levels. This measure was developed to assess DSM-5 and anxiety symptoms distinct to ASD, specifically this measure takes the unique approach of examining behaviorally oriented anxiety symptoms. This measure has demonstrated reliability and validity in the autism population. | Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session) |
| Error Related Negativity (ERN) Event-Related Potential (ERP) |
| Measure | Description | Time Frame |
|---|---|---|
| Child Behavior Checklist (CBCL) | The Child Behavior Checklist is a 118-item parent-report measure that assesses broad psychopathology in children and adolescents. In this sample, the CBCL will be used to assess behavioral metrics related to anxiety. Parents rate each item on a 3-point scale (0-2). Raw scores are converted to t-scores, with elevated t-scores indicating behavioral or emotional problems. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin Kang, PhD | Contact | 973-655-3615 | kange@montclair.edu | |
| Arabella Peters, B.A. | Contact | petersa6@montclair.edu |
| Name | Affiliation | Role |
|---|---|---|
| Erin Kang, PhD | Montclair State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montclair State University | Recruiting | Montclair | New Jersey | 07043 | United States |
The study team will meet all results reporting requirements of the funding and regulatory agencies.
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EEG systems will be used to record Error Related Negativity using the Flanker paradigm. The Flanker paradigm involves congruent (50%) and incongruent (50%) trials with arrows facing the same direction as (congruent) or the opposite direction of (incongruent) the target. The order of congruent and incongruent trials will be random. All stimuli will be presented for 200 ms followed by an inter-trial interval that varies randomly from 2,300 to 2,800 ms. The participant will be given detailed task instructions, and receive feedback based on their performance at the end of each block. Error and correct trials will be separately averaged, with the error response as the mean activity between -25 and 75ms after the error response at scalp site where error-related brain activity is maximal. In addition, the correct response negativity (CRN) will be evaluated for the same time window and site on correct trials. The ERN (i.e., the error response minus CRN) will then be calculated for analysis |
| Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session) |
| Electroencephalogram (EEG) Hemispheric Asymmetry | Resting EEG data will be collected for 6 minutes alternating between 1-min blocks of eyes open or closed (with the order counterbalanced across subjects). Baseline frontal alpha-band power during eyes-open rest will be calculated across the epoch using wavelet analysis for central frequencies (7.5-12.5 Hz) using 20 logarithmic steps at 7 cycles. To normalize the data, natural log-transformed scores will be calculated. Asymmetry scores were created as Ln(Left) - Ln(Right) for mean alpha power across F3(L)/4(R) and F7(L)/8(R) pairs. | Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session) |
| within 2 weeks of intervention completion (up to 14 weeks post first intervention session) |
| Emotion Dysregulation Inventory (EDI) | The Emotion Dysregulation Inventory is a 30-item parent-report questionnaire developed to assess facets of emotion dysregulation in autism spectrum disorder in the past seven days. These facets include reactivity (i.e., behavioral responses) and dysphoria (i.e., mental processes). Items are rated on a five-point scale (0-4) with higher ratings indicating greater dysregulation. The EDI contains two subscales: the reactivity (i.e., behavioral responses) and the dysphoria (i.e., mental processes) scale. The EDI has demonstrated both reliability and validity in the autism population. | within 2 weeks of intervention completion (up to 14 weeks post first intervention session) |
| Treatment Fidelity | Treatment Fidelity Measure assesses absence/presence of FYF treatment components; acceptability/usefulness of activities are rated. The measure utilizes a checklist format to assess the presence or absence of core treatment components on a session-by-session basis. In addition, a rating of quality will be assigned on a Likert scale ranging from poor (1), to adequate (3), to excellent (5) quality. | Each intervention session (up to 14 weeks) |
| Drexel University | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001008 | Anxiety Disorders |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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