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Search / Trial NCT06904508

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

Launched by MONTCLAIR STATE UNIVERSITY · Mar 28, 2025

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Autism Autism Spectrum Disorder Anxiety Youth Randomized Controlled Trial Cognitive Behavioral Therapy Electroencephalogram

ClinConnect Summary

This clinical trial is looking to understand how a specific treatment called Facing Your Fears (FYF) can help reduce anxiety symptoms in autistic children aged 8 to 14 who come from high-need communities. The researchers will compare two groups of children: one group will receive the FYF treatment right away, while the other group will wait for a period before starting the treatment. By studying brain activity and changes in anxiety symptoms, the researchers hope to see how effective the FYF program is for these young participants.

To be eligible for this trial, children need to be between the ages of 8 and 14 and show significant difficulties with social interaction, as well as have measurable anxiety symptoms. Participants must also be able to speak English well enough to take part in the study assessments. A legal guardian must provide consent for their child's participation and can even join in the treatment sessions if they're able. If a child has severe medical or behavioral issues that require more intensive care, they may not be eligible for the study. Overall, this trial aims to explore new ways to support autistic youth dealing with anxiety.

Gender

ALL

Eligibility criteria

  • 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

About Montclair State University

Montclair State University is a leading public research institution dedicated to advancing knowledge and improving health outcomes through innovative clinical trials. With a commitment to academic excellence and community engagement, the university leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous and ethical research. Montclair State University fosters collaboration among researchers, healthcare professionals, and participants to explore novel therapies and interventions, aiming to address pressing health challenges and contribute to the broader scientific community.

Locations

Philadelphia, Pennsylvania, United States

Montclair, New Jersey, United States

Patients applied

0 patients applied

Trial Officials

Erin Kang, PhD

Principal Investigator

Montclair State University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported