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

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.

Study Overview

• Status: Recruiting
• Conditions: Social Anxiety Disorder of Childhood
• Intervention / Treatment: Behavioral: Attention Bias Modification Treatment; Behavioral: Neutral Control Task

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeremy W Pettit, PhD; Phone Number: 305-348-1671; Email: jpettit@fiu.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale Child Study Center Program for Anxiety and Mood Disorders
      • Contact: Wendy K Silverman, PhD; Phone Number: 203-737-7053; Email: wendy.silverman@yale.edu
  • Florida
    • Miami, Florida, United States, 33199
      • Recruiting
      • Florida International University Center for Children and Families
      • Contact: Jeremy Pettit, PhD; Phone Number: 305-348-3879; Email: jpettit@fiu.edu
      • Principal Investigator: Jeremy Pettit, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Attention Bias Modification Treatment; Attention Bias Modification Treatment is a computer-based attention training program.	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.
Sham Comparator: Neutral Control Task; Neutral Control Task uses the same computer-based format as Attention Bias Modification Treatment, but includes only neutral stimuli and does not train attention.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Florida International University
• Collaborators: Yale University
• Investigators: Principal Investigator: Jeremy W Pettit, PhD, Florida International University; Principal Investigator: Wendy K Silverman, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: April 26, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: R01MH119299 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No