Clinical trial NCT03932032: Targeting Attention Orienting to Social Threat to Reduce Social Anxiety in Youth
Official title: Targeting Attention Orienting to Social Threat to Reduce Social Anxiety in Youth
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Social Anxiety Disorder of Childhood
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2019-04-30
Enrollment: 260
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: P1 amplitude elicited in the dot-probe task
timeFrame: post-intervention (within one week of completing the final treatment session)
measure: P1 amplitude elicited in the dot-probe task
timeFrame: Follow-up (six months after completing the final treatment session)
Secondary outcomes:
measure: Liebowitz Social Anxiety Scale for Children and Adolescents
timeFrame: post-intervention (within one week of completing the final treatment session)
measure: Liebowitz Social Anxiety Scale for Children and Adolescents
timeFrame: Follow-up (six months after completing the final treatment session)
measure: Screen for Child Anxiety Related Emotional Disorders - Parent Version at posttreatment
timeFrame: 7 days
measure: Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up
timeFrame: 7 days
measure: Screen for Child Anxiety Related Emotional Disorders - Child Version at posttreatment
timeFrame: 7 days
measure: Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up
timeFrame: 7 days
Other outcomes:
measure: State Anxiety before and after a Speech Task
timeFrame: post-intervention (within one week of completing the final treatment session)
measure: State Anxiety before and after a Speech Task
timeFrame: Follow-up (six months after completing the final treatment session)
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center Program for Anxiety and Mood Disorders
state: Connecticut
city: Miami
country: United States
facility: Florida International University Center for Children and Families
state: Florida
Study officials:
affiliation: Florida International University
name: Jeremy W Pettit, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Wendy K Silverman, PhD
role: PRINCIPAL_INVESTIGATOR
References: