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Social Anxiety Disorder of ChildhoodNCT03932032

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

A study testing Attention Bias Modification Treatment in people with Social Anxiety Disorder of Childhood, run by Florida International University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 10 to 14 years
Conditions the study is for
Social Anxiety Disorder of Childhood
What is being tested?
Attention Bias Modification Treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
206 participants
Where
2 sitesUnited States
Study dates
1 Jul 2019to 15 Jan 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Florida International University Center for Children and Families

    Miami, Florida, 33199

  • Yale Child Study Center Program for Anxiety and Mood Disorders

    New Haven, Connecticut, 06520

Other trials in United States

About this study

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.

Being tested
Attention Bias Modification Treatment, Neutral Control Task

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Attention Bias Modification TreatmentBehavioural

    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 TaskBehavioural

    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.

Study groups in NCT03932032
Study groupRoleWhat they receive
Attention Bias Modification TreatmentExperimentalAttention Bias Modification Treatment is a computer-based attention training program.
Receives: Behavioral: Attention Bias Modification Treatment
Neutral Control TaskSham comparatorNeutral Control Task uses the same computer-based format as Attention Bias Modification Treatment, but includes only neutral stimuli and does not train attention.
Receives: Behavioral: Neutral Control Task

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (6)
  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2019
  2. Study start1 Jul 2019
  3. Primary completion15 Jan 2026
  4. Study completion15 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03932032
Sponsor's protocol ID
R01MH119299
Status last verified
Aug 2026
First submitted
26 Apr 2019
Last updated
24 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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