Targeting Attention Orienting to Social Threat to Reduce Social Anxiety in Youth

Social Anxiety Disorder of Childhood Clinical Trial

Official title:

Targeting Attention Orienting to Social Threat to Reduce Social Anxiety in Youth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03932032
• Other study ID #: R01MH119299
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: March 31, 2025

Study information

• Verified date: January 2024
• Source: Florida International University
• Contact: Jeremy W Pettit, PhD
• Phone: 305-348-1671
• Email: jpettit[@]fiu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This two-site study is a test of Attention Bias Modification Treatment (ABMT) among 260 youths ages 10 to 14 years with social anxiety disorder. One-half of participants will receive 8 sessions of computer administered ABMT and the other half of participants will receive 8 sessions of computer administered Neutral Control Task (NCT). The investigators hypothesize that a biomarker of attention to social threat measured using electroencephalography (EEG) and ratings of social anxiety severity will be lower in participants who receive ABMT compared to participants who receive NCT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

Inclusion Criteria:

• Be between ages 10 and 14 years
• meet DSM5 criteria for a diagnosis of Social Anxiety Disorder
• presence of any coexisting psychiatric diagnoses must be of lesser severity than Social Anxiety Disorder
• have no current psychotropic medication other than a stable dose of stimulant or non-stimulant medication for coexisting ADHD

Exclusion Criteria:

• meet DSM5 criteria for Autism Spectrum Disorder, Intellectual Disability, Bipolar Disorder, Tourette's Disorder, Psychotic Disorders, or Substance Use Disorders
• show high likelihood of hurting self or others
• be a victim of undisclosed abuse requiring investigation/ supervision by the Department of Social Services
• have an uncorrected vision or physical disability that interferes with the ability to click a mouse button rapidly and repeatedly
• have a history of neurological illness, including seizures/epilepsy, or head injury with loss of consciousness > 5 minutes

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety Disorder of Childhood

Intervention

Behavioral:
• Attention Bias Modification Treatment
At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in social anxiety.
• Neutral Control Task
At each of eight sessions, participants complete 160 computer administered trials wherein a pair of neutral stimuli is presented simultaneously and then followed immediately by a probe. NCT matches ABMT on duration, format, and number of trials, but does not engage attention to social threat and does not train attention.

Locations

Country	Name	City	State
United States	Florida International University Center for Children and Families	Miami	Florida
United States	Yale Child Study Center Program for Anxiety and Mood Disorders	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Florida International University	Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	State Anxiety before and after a Speech Task	posttreatment State-Trait Anxiety Inventory for Children - State Subscale (STAIC-S) administered before and after a 3-minute speech task.	post-intervention (within one week of completing the final treatment session)
Other	State Anxiety before and after a Speech Task	Follow-up State-Trait Anxiety Inventory for Children - State Subscale (STAIC-S) administered before and after a 3-minute speech task.	Follow-up (six months after completing the final treatment session)
Primary	P1 amplitude elicited in the dot-probe task	Posttreatment event related potential amplitude elicited during the emotional faces dot probe task. The investigators will focus specifically on the P1 amplitude time-locked to the onset of facial stimuli in the dot probe task. P1 amplitude will be measured using EEG methodology.	post-intervention (within one week of completing the final treatment session)
Primary	P1 amplitude elicited in the dot-probe task	Follow-up P1 event related potential amplitude elicited during the emotional faces dot probe task. The investigators will focus specifically on the P1 amplitude time-locked to the onset of facial stimuli in the dot probe task. P1 amplitude will be measured using EEG methodology.	Follow-up (six months after completing the final treatment session)
Secondary	Liebowitz Social Anxiety Scale for Children and Adolescents	posttreatment clinician rating of youth social anxiety symptom severity over the past 7 days. The name of the measure is the Liebowitz Social Anxiety Scale for Children and Adolescents. It is a clinician rated measure of the severity of youths' social anxiety symptoms. Total scores range from 0 to 144, with higher scores representing more severe social anxiety.	post-intervention (within one week of completing the final treatment session)
Secondary	Liebowitz Social Anxiety Scale for Children and Adolescents	Follow-up clinician rating of youth social anxiety symptom severity over the past 7 days. The name of the measure is the Liebowitz Social Anxiety Scale for Children and Adolescents. It is a clinician rated measure of the severity of youths' social anxiety symptoms. Total scores range from 0 to 144, with higher scores representing more severe social anxiety.	Follow-up (six months after completing the final treatment session)
Secondary	Screen for Child Anxiety Related Emotional Disorders - Parent Version at posttreatment	posttreatment parent rating of youth social anxiety symptom severity over the past 7 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P). The SCARED-P is a parent rated measure of the severity of youths' anxiety symptoms, including social anxiety. Total scores on the SCARED-P range from 0 to 82, with higher scores representing more severe anxiety.	7 days
Secondary	Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up	follow up parent rating of youth social anxiety symptom severity over the past 7 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P). The SCARED-P is a parent rated measure of the severity of youths' anxiety symptoms, including social anxiety. Total scores on the SCARED-P range from 0 to 82, with higher scores representing more severe anxiety.	7 days
Secondary	Screen for Child Anxiety Related Emotional Disorders - Child Version at posttreatment	posttreatment child rating of youth social anxiety symptom severity over the past 7 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child rated measure of the severity of youths' anxiety symptoms, including social anxiety. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.	7 days
Secondary	Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up	Follow up child rating of youth social anxiety symptom severity over the past 7 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child rated measure of the severity of youths' anxiety symptoms, including social anxiety. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.	7 days