Autism Spectrum DisorderIAANCT06904508
Brain Activity Changes After Cognitive Behavioral Therapy for Anxiety in Autistic Youth From High-Need Communities
A study testing Facing Your Fears (FYF) Intervention: A CBT Focused Group Treatment for Autistic Youth with Anxiety in people with Autism Spectrum Disorder and Anxiety, run by Montclair State University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Autism Spectrum Disorder, Anxiety
- What is being tested?
- Facing Your Fears (FYF) Intervention: A CBT Focused Group Treatment for Autistic Youth with Anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Apr 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- Have clinically significant anxiety symptoms as defined by significant elevations on either the parent-report SCARED questionnaire or the parent-report PRAS-ASD questionnaire
- Have a legal guardian who can provide consent for their child's participation as well as their own participation in the intervention alongside their child. If the legal guardian is unable to participate in the intervention themselves but would like for their child to receive the intervention with another caregiver who lives with the child, the legal guardian will still be the one to sign the consent form, but will provide permission for another caregiver (logged on the consent form) to participate in the intervention alongside the child
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Arabella Peters, B.A. contact
United States2 sites, 2 recruiting
- Recruiting
Montclair State University
Montclair, New Jersey, 07043
Erin Kang, PhD, 973-655-3615, kange@montclair.edu
- Recruiting
Drexel University
Philadelphia, Pennsylvania, 19104
Tamara Rosen, PhD, 215-571-3401, ter32@drexel.edu
About this study
Official title: Electrophysiological Correlates of Anxiety-related Improvements Following Cognitive Behavioral Therapy for Autistic Youth in High-Need Communities
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.
Read more
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
Read the detailed description
Aims of the study:
- How do brain activity patterns (measured by EEG) relate to anxiety symptoms in autistic youth, as reported by both the youth and their parents?
- Will brain activity changes line up with improvements in anxiety after FYF treatment in autistic youth from underserved communities?
- Will brain activity relate to other factors related to anxiety (e.g., a person's ability to handle uncertainty and manage emotions)?
- Conditions
- Autism Spectrum Disorder, Anxiety
- Being tested
- Facing Your Fears (FYF) Intervention: A CBT Focused Group Treatment for Autistic Youth with Anxiety
- Keywords
- autism, autism spectrum disorder, anxiety, youth, randomized controlled trial, cognitive behavioral therapy, electroencephalogram
- Medical subject headings
- Autism Spectrum Disorder, Anxiety Disorders, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facing Your Fears (FYF) Intervention: A CBT Focused Group Treatment for Autistic Youth with AnxietyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Facing Your Fears (FYF) Intervention: A CBT Focused Group Treatment for Autistic Youth with Anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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..
Measured: 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.
Measured: Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)
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
Measured: 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.
Measured: Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Each intervention session (up to 14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start30 Apr 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montclair State University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Drexel University
- Responsible party
- Sponsor
- Investigators
- Erin Kang, PhD, Principal investigator, Montclair State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904508
- Sponsor's protocol ID
- IRB-FY23-24-3257
- Other IDs
- CDMRP-AR230226
- Acronym
- IAA
- Status last verified
- Jun 2025
- First submitted
- 21 Feb 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study team will meet all results reporting requirements of the funding and regulatory agencies.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Correlates of Anxiety-related Improvements Following Cognitive Behavioral Therapy for Autistic Youth in High-Need Communities
- ClinicalTrials.gov ID
- NCT06904508
- Acronym / sponsor ID
- IAA / IRB-FY23-24-3257
- Conditions
- Autism Spectrum Disorder, Anxiety
- Keywords
- autism, autism spectrum disorder, anxiety, youth, randomized controlled trial, cognitive behavioral therapy, electroencephalogram
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Montclair State UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Drexel University
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Aims of the study:
- How do brain activity patterns (measured by EEG) relate to anxiety symptoms in autistic youth, as reported by both the youth and their parents?
- Will brain activity changes line up with improvements in anxiety after FYF treatment in autistic youth from underserved communities?
- Will brain activity relate to other factors related to anxiety (e.g., a person's ability to handle uncertainty and manage emotions)?
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Facing Your Fears (FYF) Intervention: A CBT Focused Group Treatment for Autistic Youth with AnxietyThe 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. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
- Have clinically significant anxiety symptoms as defined by significant elevations on either the parent-report SCARED questionnaire or the parent-report PRAS-ASD questionnaire
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facing Your Fears (FYF) Intervention: A CBT Focused Group Treatment for Autistic Youth with AnxietyFYF 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). | Behavioural | Treatment Condition: Facing Your Fears (FYF) Group |
Primary outcome
The Screen for Child Anxiety and Related Disorders (SCARED-P/C)
Time frame: Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)
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.
Anxiety Scale for Children-Autism Spectrum Disorder Scale (ASC-ASD)
Time frame: Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)
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..
Parent Rated Anxiety Scale for Autism Spectrum Disorder (PRAS-ASD)
Time frame: Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)
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.
Error Related Negativity (ERN) Event-Related Potential (ERP)
Time frame: Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)
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
Electroencephalogram (EEG) Hemispheric Asymmetry
Time frame: Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)
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.
3 secondary outcomes
Child Behavior Checklist (CBCL)
Time frame: within 2 weeks of intervention completion (up to 14 weeks post first intervention session)
Emotion Dysregulation Inventory (EDI)
Time frame: within 2 weeks of intervention completion (up to 14 weeks post first intervention session)
Treatment Fidelity
Time frame: Each intervention session (up to 14 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No. The study team will meet all results reporting requirements of the funding and regulatory agencies.
Related trials for Autism Spectrum Disorder
Recruiting
Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Recruiting
Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder: Raynor Cerebellum Project
Autism Spectrum Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Not yet recruiting
Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents
Sleep, Autism Spectrum Disorder
RecruitingObservational study
Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arabella Peters, B.A. contact
Erin Kang, PhD principal investigator
Montclair State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facing Your Fears (FYF) Intervention: A CBT Focused Group Treatment for Autistic Youth with Anxiety in people with Autism Spectrum Disorder and Anxiety, run by Montclair State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Kang, PhD (973-655-3615, kange@montclair.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Screen for Child Anxiety and Related Disorders (SCARED-P/C) (time frame: Baseline and within 2 weeks of intervention completion (up to 14 weeks post first intervention session)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.