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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Social Anxiety Disorder of Childhood
- 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 group | Role | What they receive |
|---|---|---|
| Attention Bias Modification Treatment | Experimental | Attention Bias Modification Treatment is a computer-based attention training program. Receives: Behavioral: Attention Bias Modification Treatment |
| 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. Receives: Behavioral: Neutral Control Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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)
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)
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)
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)
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)
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.
- First posted30 Apr 2019
- Study start1 Jul 2019
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Social Anxiety Disorder of ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Jeremy W Pettit, PhD, Principal investigator, Florida International UniversityWendy K Silverman, PhD, Principal investigator, Yale University
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No