Brain Activity Changes After Cognitive Behavioral Therapy for Anxiety in Autistic Youth From High-Need Communities
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-14
SponsorMontclair State University
About this trial
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:
* Complete the Facing Your Fears (FYF) intervention if assigned to the immediate treatment group * Continue their usual treatment during a waitlist period if assigned to the control group, followed by the opportunity to participate in FYF intervention after the waiting period ends * Complete assessments of neural constructs, anxiety symptoms, and other measures
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between the ages of 8 and 14
Have significant deficits in reciprocal social behavior as defined by a score of 11 or above on the parent-report SCQ questionnaire
Are verbally fluent in English, enabling them to participate in the appropriate modules (3 or 4) of the researcher-administered ADOS-2
Have an estimated verbal IQ of 70 or above as determined by the researcher-administered KBIT-2
Disqualifiers
Fail to meet any of the above inclusion criteria
If it is determined by the research team via parent report or direct observation that the child has a severe medical or psychiatric impairment (e.g., psychosis, severe aggressive behavior, or other severe clinical symptoms) that require more intensive treatment such as day treatment or hospitalization
Trial design
Design model
Parallel
Treatments tested in this trial
Facing Your Fears (FYF) Intervention: A CBT Focused Group Treatment for Autistic Youth with Anxiety
BehavioralFYF 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).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Waitlist-Control ConditionNo intervention 0 interventions
Group B: Treatment Condition: Facing Your Fears (FYF) GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)2
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..
Time frame
Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)3
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.
Time frame
Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)4
Error Related Negativity (ERN) Event-Related Potential (ERP)
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
Time frame
Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)Secondary outcomes
1
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.
Time frame
within 2 weeks of intervention completion (up to 14 weeks post first intervention session)2
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.
Time frame
within 2 weeks of intervention completion (up to 14 weeks post first intervention session)3
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.
Time frame
Each intervention session (up to 14 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Montclair State University
Lead sponsor
Children's Hospital of Philadelphia
Collaborator
Drexel University
Collaborator
Source ClinicalTrials.gov