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

NCT03932032 | Completed Results DMC

• 1 other identifier: R01MH119299
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Social Anxiety Disorder of Childhood

Outcome Measures

Primary Outcomes (2)

• P1 Amplitude Elicited in the Dot-probe Task

  Posttreatment event related potential amplitude elicited during the emotional faces dot probe task. The investigators focused specifically on the P1 amplitude time-locked to the onset of emotional facial stimuli in the dot probe task. P1 amplitude was measured using EEG methodology. Higher scores indicate greater allocation of neural resources when viewing stimuli in the dot probe task, which can be interpreted as an indicator of greater attention orientation to emotional facial stimuli.

  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 focused specifically on the P1 amplitude time-locked to the onset of emotional facial stimuli in the dot probe task. P1 amplitude was measured using EEG methodology. Higher scores indicate greater allocation of neural resources when viewing stimuli in the dot probe task, which can be interpreted as an indicator of greater attention orientation to emotional facial stimuli.

  Follow-up (six months after completing the final treatment session)

Secondary Outcomes (6)

• Liebowitz Social Anxiety Scale for Children and Adolescents

  post-intervention (within one week of completing the final treatment session)

• Liebowitz Social Anxiety Scale for Children and Adolescents

  Follow-up (six months after completing the final treatment session)

• Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment

  post-intervention (within one week of completing the final treatment session)

• Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up

  Follow-up (six months after completing the final treatment session)

• Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment

  post-intervention (within one week of completing the final treatment session)

Other Outcomes (4)

• State Anxiety Before a Speech Task

  post-intervention (within one week of completing the final treatment session)

• State Anxiety Before a Speech Task

  Follow-up (six months after completing the final treatment session)

• State Anxiety After a Speech Task

  post-intervention (within one week of completing the final treatment session)

Study Arms (2)

Attention Bias Modification Treatment

EXPERIMENTAL

Attention Bias Modification Treatment is a computer-based attention training program.

Behavioral: Attention Bias Modification Treatment

Neutral Control Task

SHAM COMPARATOR

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

Interventions

Attention Bias Modification Treatment BEHAVIORAL

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.

Attention Bias Modification Treatment

Neutral Control Task BEHAVIORAL

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.

Neutral Control Task

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida International University: lead
• Yale University: collaborator

Study Sites (2)

Yale Child Study Center Program for Anxiety and Mood Disorders

New Haven, Connecticut, 06520, United States

Location

Florida International University Center for Children and Families

Miami, Florida, 33199, United States

Location

Results Point of Contact

• Title: Jeremy Pettit
• Organization: Florida International University

jpettit@fiu.edu

3053481671

Study Officials

• Jeremy W Pettit, PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

• Wendy K Silverman, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: April 30, 2019
• Study Start: July 1, 2019
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: April 29, 2026
• Results First Posted: April 29, 2026

Record last verified: 2026-04

Locations

US (2)