RECRUITING

Very Brief Exposure: Development of a Novel Exposure Modality for Social Anxiety Disorder in Transition-Age Youth

Conditions

Social Anxiety Disorder Youth Very Brief Exposure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to identify the circuit activations by very brief exposure (VBE) among youth with social anxiety disorder (SAD) in order to develop a novel intervention for those with SAD. The secondary objectives of this study are to measure the effect of VBE on subjective fear ratings, and participants' awareness and tolerance of the exposure stimuli. * The primary outcome of this study is the mean activation of frontostriatal and prefrontal brain regions to facial stimuli, as measured by Blood Oxygen Level Dependent (BOLD) response, in 4 regions of interest during the magnetic resonance imaging (MRI). * Another primary outcome of the study is to identify networks of regions subserving emotion regulation and attention, as measured by BOLD response of corresponding brain regions. Secondary Outcomes -The secondary outcome of this study is the fear induced by exposure to facial expression stimuli as measured by a 4-point fear scale during the functional magnetic resonance imaging (fMRI) after each block of 10 facial expression stimuli trials. Participants will participate in an interview where they will answer questions both inside and outside of the MRI scan. Participants will be asked to rate on a scale the imagines they see while undergoing MRI scan.

Official Title

Very Brief Exposure: Development of a Novel Exposure Modality for Social Anxiety Disorder in Transition-Age Youth

Quick Facts

Study Start:2024-08-14

Study Completion:2026-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06526260

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Patient Population * Males and females aged 16-22. This age range corresponds with our prior studies of very brief exposure (VBE) in Specific Phobia and will include older adolescents while minimizing potential developmental effects on circuit activation. * Youth with a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of Social Anxiety Disorder (SAD) on Kiddie Schedule for Affective Disorders and Schizophrenia for School-Aged Children, Computerized version (K-SADS-COMP) for youth ages 16-17, or the computerized version of Structured Clinical Interview for the DSM-5 (NetSCID) for youth ages 18+. * Healthy Population * Parents • Parent/caregiver of all ages, no restrictions who are fluent in either English or Spanish.	* Patient Population * Primary language other than English or Spanish. * Active suicidality on the Colombia-Suicide Severity Scale (plan, intent, or behavior) * Ferromagnetic implants (e.g., pacemaker), metal braces, retainers, tattoos or permanent make-up with metallic content, transdermal medicinal patches that cannot be removed. * Current psychoactive medication. * Lifetime diagnosis of: obsessive-compulsive disorder (OCD), psychotic, bipolar, autism spectrum disorder, intellectual disability on the KSADS-COMP or NetSCID. * Any serious neurological or medical conditions (e.g., Lupus, cancer, human immunodeficiency virus positive (HIV+)) as reported by potential participants. * Current Post-Traumatic Stress Disorder (PTSD) diagnosis. * Current severe substance abuse (except tobacco/nicotine). * Pregnancy, as determined by the participant's self-report prior to the magnetic resonance imaging (MRI) scan. * Healthy Population * Primary language other than English or Spanish. * Lifetime disorders: any anxiety disorders, OCD, psychotic, bipolar, autism spectrum disorder, intellectual disability; any psychiatric disorder in the past 2 years * Current depression disorder. * Active psychiatric disorder in the past 2 years. * Serious neurological or medical conditions. * Current psychoactive medication. * Ferromagnetic implants (e.g., pacemaker), metal braces, retainers, tattoos or permanent make-up with metallic content, transdermal medicinal patches that cannot be removed. * Active suicidality on the Colombia-Suicide Severity Scale (plan, intent, or behavior). * Pregnancy, as determined by the participant's self-report prior to the MRI scan. * Parents • Primary language other than English or Spanish.

Inclusion Criteria

Exclusion Criteria

* Patient Population
* Males and females aged 16-22. This age range corresponds with our prior studies of very brief exposure (VBE) in Specific Phobia and will include older adolescents while minimizing potential developmental effects on circuit activation.
* Youth with a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of Social Anxiety Disorder (SAD) on Kiddie Schedule for Affective Disorders and Schizophrenia for School-Aged Children, Computerized version (K-SADS-COMP) for youth ages 16-17, or the computerized version of Structured Clinical Interview for the DSM-5 (NetSCID) for youth ages 18+.
* Healthy Population
* Parents • Parent/caregiver of all ages, no restrictions who are fluent in either English or Spanish.

* Patient Population
* Primary language other than English or Spanish.
* Active suicidality on the Colombia-Suicide Severity Scale (plan, intent, or behavior)
* Ferromagnetic implants (e.g., pacemaker), metal braces, retainers, tattoos or permanent make-up with metallic content, transdermal medicinal patches that cannot be removed.
* Current psychoactive medication.
* Lifetime diagnosis of: obsessive-compulsive disorder (OCD), psychotic, bipolar, autism spectrum disorder, intellectual disability on the KSADS-COMP or NetSCID.
* Any serious neurological or medical conditions (e.g., Lupus, cancer, human immunodeficiency virus positive (HIV+)) as reported by potential participants.
* Current Post-Traumatic Stress Disorder (PTSD) diagnosis.
* Current severe substance abuse (except tobacco/nicotine).
* Pregnancy, as determined by the participant's self-report prior to the magnetic resonance imaging (MRI) scan.
* Healthy Population
* Primary language other than English or Spanish.
* Lifetime disorders: any anxiety disorders, OCD, psychotic, bipolar, autism spectrum disorder, intellectual disability; any psychiatric disorder in the past 2 years
* Current depression disorder.
* Active psychiatric disorder in the past 2 years.
* Serious neurological or medical conditions.
* Current psychoactive medication.
* Ferromagnetic implants (e.g., pacemaker), metal braces, retainers, tattoos or permanent make-up with metallic content, transdermal medicinal patches that cannot be removed.
* Active suicidality on the Colombia-Suicide Severity Scale (plan, intent, or behavior).
* Pregnancy, as determined by the participant's self-report prior to the MRI scan.
* Parents • Primary language other than English or Spanish.

Contacts and Locations

Study Contact

Courtney Marcelino

CONTACT

323-361-6456

cmarcelino@chla.usc.edu

Bradley S Peterson, MD

CONTACT

323-361-3654

bpeterson@chla.usc.edu

Principal Investigator

Bradley S Peterson, MD

PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Study Locations (Sites)

Children's Hospital Los Angeles

Los Angeles, California, 90027

United States

Collaborators and Investigators

Sponsor: Children's Hospital Los Angeles

Bradley S Peterson, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-14

Study Completion Date2026-01-01

Study Record Updates

Study Start Date2024-08-14

Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

Youth
Very Brief Exposure

Additional Relevant MeSH Terms

Social Anxiety Disorder