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

Study Overview
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Brief Summary
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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.

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

Conditions
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Social Anxiety Disorder of Childhood

Intervention / Treatment
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* Behavioral: Attention Bias Modification Treatment
* Behavioral: Neutral Control Task


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Attention Bias Modification Treatment<br>Attention Bias Modification Treatment is a computer-based attention training program. | Behavioral: Attention Bias Modification Treatment<br>* 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.<br>|
| Sham Comparator: Neutral Control Task<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P1 amplitude elicited in the dot-probe task | Posttreatment 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. | 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 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. | Follow-up (six months after completing the final treatment session) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liebowitz Social Anxiety Scale for Children and Adolescents | posttreatment clinician rating of youth social anxiety symptom severity over the past 7 days. The name of the measure is the Liebowitz Social Anxiety Scale for Children and Adolescents. It is a clinician rated measure of the severity of youths' social anxiety symptoms. Total scores range from 0 to 144, with higher scores representing more severe social anxiety. | post-intervention (within one week of completing the final treatment session) | 
| Liebowitz Social Anxiety Scale for Children and Adolescents | Follow-up clinician rating of youth social anxiety symptom severity over the past 7 days. The name of the measure is the Liebowitz Social Anxiety Scale for Children and Adolescents. It is a clinician rated measure of the severity of youths' social anxiety symptoms. Total scores range from 0 to 144, with higher scores representing more severe social anxiety. | Follow-up (six months after completing the final treatment session) | 
| Screen for Child Anxiety Related Emotional Disorders - Parent Version at posttreatment | posttreatment parent rating of youth social anxiety symptom severity over the past 7 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P). The SCARED-P is a parent rated measure of the severity of youths' anxiety symptoms, including social anxiety. Total scores on the SCARED-P range from 0 to 82, with higher scores representing more severe anxiety. | 7 days | 
| Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up | follow up parent rating of youth social anxiety symptom severity over the past 7 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P). The SCARED-P is a parent rated measure of the severity of youths' anxiety symptoms, including social anxiety. Total scores on the SCARED-P range from 0 to 82, with higher scores representing more severe anxiety. | 7 days | 
| Screen for Child Anxiety Related Emotional Disorders - Child Version at posttreatment | posttreatment child rating of youth social anxiety symptom severity over the past 7 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child rated measure of the severity of youths' anxiety symptoms, including social anxiety. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety. | 7 days | 
| Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up | Follow up child rating of youth social anxiety symptom severity over the past 7 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child rated measure of the severity of youths' anxiety symptoms, including social anxiety. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety. | 7 days |