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| Name | Class |
|---|---|
| Yale University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention Bias Modification Treatment | Experimental | Attention Bias Modification Treatment is a computer-based attention training program. |
|
| Neutral Control Task | Sham Comparator | Neutral Control Task uses the same computer-based format as Attention Bias Modification Treatment, but includes only neutral stimuli and does not train attention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attention Bias Modification Treatment | 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. |
| 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 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. | 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 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. | Follow-up (six months after completing the final treatment session) |
| Measure | Description | Time Frame |
|---|---|---|
| Liebowitz Social Anxiety Scale for Children and Adolescents | posttreatment clinician rating of youth social anxiety symptom severity. A single rating is made to characterize overall social anxiety symptom severity aggregated 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. |
| Measure | Description | Time Frame |
|---|---|---|
| State Anxiety Before a Speech Task | posttreatment State-Trait Anxiety Inventory for Children - State Subscale (STAIC-S) administered before a 3-minute speech task. Participants were told that they would give a video-recorded speech about their strengths and weaknesses for three minutes, and then given three minutes to prepare for the speech. At the end of the three-minute preparation period, participants were administered the STAIC-S. The STAIC-S measures state (momentary) levels of anxiety. Total scores range from 20 to 60, with higher scores indicating higher levels of anxiety. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy W Pettit, PhD | Florida International University | Principal Investigator |
| Wendy K Silverman, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Child Study Center Program for Anxiety and Mood Disorders | New Haven | Connecticut | 06520 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Attention Bias Modification Treatment | Attention Bias Modification Treatment is a computer-based attention training program. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Attention Bias Modification Treatment | Attention Bias Modification Treatment is a computer-based attention training program. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | P1 Amplitude Elicited in the Dot-probe Task | 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. | Posted | Mean | Standard Deviation | microvolts | post-intervention (within one week of completing the final treatment session) |
|
from enrollment until end of follow-up at 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Attention Bias Modification Treatment | Attention Bias Modification Treatment is a computer-based attention training program. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeremy Pettit | Florida International University | 3053481671 | jpettit@fiu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2026 | Mar 10, 2026 | Prot_SAP_000.pdf |
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|
| Neutral Control Task | 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. |
|
| 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. A single rating is made to characterize overall social anxiety symptom severity aggregated 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. A single rating is made to characterize overall social anxiety symptom severity aggregated 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. | 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 parent rating of youth social anxiety symptom severity. A single rating is made to characterize overall social anxiety symptom severity aggregated 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. | Follow-up (six months after completing the final treatment session) |
| Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment | posttreatment child rating of youth social anxiety symptom severity. A single rating is made to characterize overall social anxiety symptom severity aggregated 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. | 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 child rating of youth social anxiety symptom severity. A single rating is made to characterize overall social anxiety symptom severity aggregated 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. | Follow-up (six months after completing the final treatment session) |
| post-intervention (within one week of completing the final treatment session) |
| State Anxiety Before a Speech Task | Follow-up State-Trait Anxiety Inventory for Children - State Subscale (STAIC-S) administered before a 3-minute speech task. Participants were told that they would give a video-recorded speech about their strengths and weaknesses for three minutes, and then given three minutes to prepare for the speech. At the end of the three-minute preparation period, participants were administered the STAIC-S. The STAIC-S measures state (momentary) levels of anxiety. Total scores range from 20 to 60, with higher scores indicating higher levels of anxiety. | Follow-up (six months after completing the final treatment session) |
| State Anxiety After a Speech Task | posttreatment State-Trait Anxiety Inventory for Children - State Subscale (STAIC-S) administered after a 3-minute speech task. Participants were told that they would give a video-recorded speech about their strengths and weaknesses for three minutes, and then given three minutes to prepare for the speech. At the end of the three-minute preparation period, participants gave the speech. After giving the speech, they were administered the STAIC-S. The STAIC-S measures state (momentary) levels of anxiety. Total scores range from 20 to 60, with higher scores indicating higher levels of anxiety. | post-intervention (within one week of completing the final treatment session) |
| State Anxiety After a Speech Task | follow-up State-Trait Anxiety Inventory for Children - State Subscale (STAIC-S) administered after a 3-minute speech task. Participants were told that they would give a video-recorded speech about their strengths and weaknesses for three minutes, and then given three minutes to prepare for the speech. At the end of the three-minute preparation period, participants gave the speech. After giving the speech, they were administered the STAIC-S. The STAIC-S measures state (momentary) levels of anxiety. Total scores range from 20 to 60, with higher scores indicating higher levels of anxiety. | 6 months after completing the final treatment session |
| Florida International University Center for Children and Families |
| Miami |
| Florida |
| 33199 |
| United States |
| BG002 | Total | Total of all reporting groups |
| age in years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| P1 amplitude elicited in the dot-probe task | 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. | Mean | Standard Deviation | microvolts |
|
| Liebowitz Social Anxiety Scale for Children and Adolescents | Baseline clinician rating of youth social anxiety symptom severity. A single rating is made to characterize overall social anxiety symptom severity aggregated 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. | Mean | Standard Deviation | units on a scale |
|
| 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. |
|
|
| Primary | 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 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. | Posted | Mean | Standard Deviation | microvolts | Follow-up (six months after completing the final treatment session) |
|
|
|
| Secondary | Liebowitz Social Anxiety Scale for Children and Adolescents | posttreatment clinician rating of youth social anxiety symptom severity. A single rating is made to characterize overall social anxiety symptom severity aggregated 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. | Posted | Mean | Standard Deviation | units on a scale | post-intervention (within one week of completing the final treatment session) |
|
|
|
| Secondary | Liebowitz Social Anxiety Scale for Children and Adolescents | Follow-up clinician rating of youth social anxiety symptom severity. A single rating is made to characterize overall social anxiety symptom severity aggregated 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. | Posted | Mean | Standard Deviation | units on a scale | Follow-up (six months after completing the final treatment session) |
|
|
|
| Secondary | Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment | posttreatment parent rating of youth social anxiety symptom severity. A single rating is made to characterize overall social anxiety symptom severity aggregated 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. | Posted | Mean | Standard Deviation | units on a scale | post-intervention (within one week of completing the final treatment session) |
|
|
|
| Secondary | Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up | follow up parent rating of youth social anxiety symptom severity. A single rating is made to characterize overall social anxiety symptom severity aggregated 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. | Posted | Mean | Standard Deviation | units on a scale | Follow-up (six months after completing the final treatment session) |
|
|
|
| Secondary | Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment | posttreatment child rating of youth social anxiety symptom severity. A single rating is made to characterize overall social anxiety symptom severity aggregated 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. | Posted | Mean | Standard Deviation | units on a scale | post-intervention (within one week of completing the final treatment session) |
|
|
|
| Secondary | Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up | Follow up child rating of youth social anxiety symptom severity. A single rating is made to characterize overall social anxiety symptom severity aggregated 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. | Posted | Mean | Standard Deviation | units on a scale | Follow-up (six months after completing the final treatment session) |
|
|
|
| Other Pre-specified | State Anxiety Before a Speech Task | posttreatment State-Trait Anxiety Inventory for Children - State Subscale (STAIC-S) administered before a 3-minute speech task. Participants were told that they would give a video-recorded speech about their strengths and weaknesses for three minutes, and then given three minutes to prepare for the speech. At the end of the three-minute preparation period, participants were administered the STAIC-S. The STAIC-S measures state (momentary) levels of anxiety. Total scores range from 20 to 60, with higher scores indicating higher levels of anxiety. | Posted | Mean | Standard Deviation | units on a scale | post-intervention (within one week of completing the final treatment session) |
|
|
|
| Other Pre-specified | State Anxiety Before a Speech Task | Follow-up State-Trait Anxiety Inventory for Children - State Subscale (STAIC-S) administered before a 3-minute speech task. Participants were told that they would give a video-recorded speech about their strengths and weaknesses for three minutes, and then given three minutes to prepare for the speech. At the end of the three-minute preparation period, participants were administered the STAIC-S. The STAIC-S measures state (momentary) levels of anxiety. Total scores range from 20 to 60, with higher scores indicating higher levels of anxiety. | Posted | Mean | Standard Deviation | units on a scale | Follow-up (six months after completing the final treatment session) |
|
|
|
| Other Pre-specified | State Anxiety After a Speech Task | posttreatment State-Trait Anxiety Inventory for Children - State Subscale (STAIC-S) administered after a 3-minute speech task. Participants were told that they would give a video-recorded speech about their strengths and weaknesses for three minutes, and then given three minutes to prepare for the speech. At the end of the three-minute preparation period, participants gave the speech. After giving the speech, they were administered the STAIC-S. The STAIC-S measures state (momentary) levels of anxiety. Total scores range from 20 to 60, with higher scores indicating higher levels of anxiety. | Posted | Mean | Standard Deviation | units on a scale | post-intervention (within one week of completing the final treatment session) |
|
|
|
| Other Pre-specified | State Anxiety After a Speech Task | follow-up State-Trait Anxiety Inventory for Children - State Subscale (STAIC-S) administered after a 3-minute speech task. Participants were told that they would give a video-recorded speech about their strengths and weaknesses for three minutes, and then given three minutes to prepare for the speech. At the end of the three-minute preparation period, participants gave the speech. After giving the speech, they were administered the STAIC-S. The STAIC-S measures state (momentary) levels of anxiety. Total scores range from 20 to 60, with higher scores indicating higher levels of anxiety. | Posted | Mean | Standard Deviation | units on a scale | 6 months after completing the final treatment session |
|
|
|
| 0 |
| 105 |
| 0 |
| 105 |
| 0 |
| 105 |
| EG001 | 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. | 0 | 101 | 0 | 101 | 0 | 101 |
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