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

• ClinicalTrials.gov Identifier: NCT03932032
• Recruitment Status: Recruiting
• First Posted: April 30, 2019
• Last Update Posted: December 2, 2021
• Sponsor: Florida International University
• Collaborator: Yale University
• Information provided by (Responsible Party): Florida International University

Study Description

Brief 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 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.

Condition or disease	Intervention/treatment	Phase
Social Anxiety Disorder of Childhood	Behavioral: Attention Bias Modification Treatment; Behavioral: Neutral Control Task	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Targeting Attention Orienting to Social Threat to Reduce Social Anxiety in Youth
• Actual Study Start Date: July 1, 2019
• Estimated Primary Completion Date: March 31, 2024
• Estimated Study Completion Date: March 31, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Attention Bias Modification Treatment; Attention Bias Modification Treatment is a computer-based attention training program.	Behavioral: Attention Bias Modification Treatment; 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.
Sham Comparator: 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.	Behavioral: Neutral Control Task; 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.

Outcome Measures

Primary Outcome Measures :

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 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.
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 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.

Secondary Outcome Measures :

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 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 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: 7 days ]
   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.
4. Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up [ Time Frame: 7 days ]
   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.
5. Screen for Child Anxiety Related Emotional Disorders - Child Version at posttreatment [ Time Frame: 7 days ]
   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.
6. Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up [ Time Frame: 7 days ]
   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.

Other Outcome Measures:

1. State Anxiety before and 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 before and after a 3-minute speech task.
2. State Anxiety before and after 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 and after a 3-minute speech task.

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 14 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Jeremy W Pettit, PhD; 305-348-1671; jpettit@fiu.edu

Locations

United States, Connecticut

Yale Child Study Center Program for Anxiety and Mood Disorders; Recruiting

New Haven, Connecticut, United States, 06520

Contact: Wendy K Silverman, PhD 203-737-7053 wendy.silverman@yale.edu

United States, Florida

Florida International University Center for Children and Families; Recruiting

Miami, Florida, United States, 33199

Contact: Jeremy Pettit, PhD 305-348-3879 jpettit@fiu.edu

Principal Investigator: Jeremy Pettit, PhD

Sponsors and Collaborators

Florida International University

Yale University

Investigators

• Principal Investigator: Jeremy W Pettit, PhD; Florida International University
• Principal Investigator: Wendy K Silverman, PhD; Yale University

More Information

• Responsible Party: Florida International University
• ClinicalTrials.gov Identifier: NCT03932032
• Other Study ID Numbers: R01MH119299 ( U.S. NIH Grant/Contract )
• First Posted: April 30, 2019
• Last Update Posted: December 2, 2021
• Last Verified: November 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anxiety Disorders; Phobia, Social; Mental Disorders; Phobic Disorders