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

NCT ID: NCT03932032

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2026-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Attention Bias Modification Treatment

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

Group Type: EXPERIMENTAL

Attention Bias Modification Treatment

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Neutral Control Task

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

Florida International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeremy W Pettit, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida International University

Wendy K Silverman, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale Child Study Center Program for Anxiety and Mood Disorders

New Haven, Connecticut, United States

Florida International University Center for Children and Families

Miami, Florida, United States

Countries

United States

Other Identifiers

R01MH119299

Identifier Type: NIH

Identifier Source: org_study_id

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