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Clinical Trials/NCT03932032
NCT03932032
Completed
Not Applicable

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

Florida International University4 sites in 1 country206 target enrollmentJuly 1, 2019

Overview

Phase
Not Applicable
Intervention
Attention Bias Modification Treatment
Conditions
Social Anxiety Disorder of Childhood
Sponsor
Florida International University
Enrollment
206
Locations
4
Primary Endpoint
P1 amplitude elicited in the dot-probe task
Status
Completed
Last Updated
3 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2019
End Date
January 15, 2026
Last Updated
3 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Attention Bias Modification Treatment

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

Intervention: Attention Bias Modification Treatment

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.

Intervention: Neutral Control Task

Outcomes

Primary Outcomes

P1 amplitude elicited in the dot-probe task

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

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.

P1 Amplitude Elicited in the Dot-probe Task

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

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.

P1 Amplitude Elicited in the Dot-probe Task

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

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.

Secondary Outcomes

  • Screen for Child Anxiety Related Emotional Disorders - Child Version at posttreatment(7 days)
  • Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up(7 days)
  • Screen for Child Anxiety Related Emotional Disorders - Parent Version at posttreatment(7 days)
  • Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up(7 days)
  • Liebowitz Social Anxiety Scale for Children and Adolescents(Follow-up (six months after completing the final treatment session))
  • Liebowitz Social Anxiety Scale for Children and Adolescents(post-intervention (within one week of 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))
  • Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up(Follow-up (six months after completing the final treatment session))

Study Sites (4)

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