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Completed

NCT Number: NCT03932032

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

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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Key information

Conditions

Social Anxiety Disorder of Childhood

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Child Study Center Program for Anxiety and Mood Disorders, New Haven, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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

  1. Liebowitz Social Anxiety Scale for Children and Adolescents

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

    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.

  2. Liebowitz Social Anxiety Scale for Children and Adolescents

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

    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.

  3. Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment

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

    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.

  4. Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up

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

    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.

  5. Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment

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

    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.

  6. Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up

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

    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.

Other outcomes

  1. State Anxiety Before a Speech Task

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

    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.

  2. State Anxiety Before a Speech Task

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

    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.

  3. State Anxiety After a Speech Task

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

    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.

  4. State Anxiety After a Speech Task

    Time frame: 6 months after completing the final treatment session

    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.

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Collaborators

  • Yale University

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Apr 30, 2019
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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