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

Florida International University (FIU)

Status: Active, not recruiting

Conditions: Social Anxiety Disorder of Childhood

Treatments: Behavioral: Neutral Control Task; Behavioral: Attention Bias Modification Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03932032

R01MH119299

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: All

Ages: 10 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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260 participants in 2 patient groups

Attention Bias Modification Treatment

Experimental group

Description:

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

Treatment:

Behavioral: Attention Bias Modification Treatment

Neutral Control Task

Sham Comparator group

Description:

Neutral Control Task uses the same computer-based format as Attention Bias Modification Treatment, but includes only neutral stimuli and does not train attention.

Treatment:

Behavioral: Neutral Control Task