Brain Activity Changes After Cognitive Behavioral Therapy for Anxiety in Autistic Youth From High-Need Communities (IAA)

Montclair State University

Status: Enrolling

Conditions: Autism Spectrum Disorder; Anxiety

Treatments: Behavioral: Facing Your Fears (FYF) Intervention: A CBT Focused Group Treatment for Autistic Youth with Anxiety

Study type: Interventional

Funder types: Other

Identifiers

NCT06904508

CDMRP-AR230226 (Other Grant/Funding Number)

IRB-FY23-24-3257

Details and patient eligibility

About

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

Full 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)?

Enrollment: 60 estimated patients

Sex: All

Ages: 8 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Waitlist-Control Condition

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Facing Your Fears (FYF) Intervention: A CBT Focused Group Treatment for Autistic Youth with Anxiety