Back to resultsTargeting Attention Orienting to Social Threat to Reduce Social Anxiety in Youth
Primary Purpose
Social Anxiety Disorder of Childhood
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attention Bias Modification Treatment
Neutral Control Task
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety Disorder of Childhood
Eligibility 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
Sites / Locations
- Yale Child Study Center Program for Anxiety and Mood DisordersRecruiting
- Florida International University Center for Children and FamiliesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Attention Bias Modification Treatment
Neutral Control Task
Arm Description
Attention Bias Modification Treatment is a computer-based attention training program.
Neutral Control Task uses the same computer-based format as Attention Bias Modification Treatment, but includes only neutral stimuli and does not train attention.
Outcomes
Primary Outcome Measures
P1 amplitude elicited in the dot-probe task
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.
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 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
Liebowitz Social Anxiety Scale for Children and Adolescents
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.
Liebowitz Social Anxiety Scale for Children and Adolescents
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.
Screen for Child Anxiety Related Emotional Disorders - Parent Version at posttreatment
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.
Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up
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.
Screen for Child Anxiety Related Emotional Disorders - Child Version at posttreatment
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.
Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up
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.
Full Information
NCT ID
NCT03932032
First Posted
April 26, 2019
Last Updated
December 15, 2022
Sponsor
Florida International University
Collaborators
Yale University
1. Study Identification
Unique Protocol Identification Number
NCT03932032
Brief Title
Targeting Attention Orienting to Social Threat to Reduce Social Anxiety in Youth
Official Title
Targeting Attention Orienting to Social Threat to Reduce Social Anxiety in Youth
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida International University
Collaborators
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder of Childhood
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Attention Bias Modification Treatment
Arm Type
Experimental
Arm Description
Attention Bias Modification Treatment is a computer-based attention training program.
Arm Title
Neutral Control Task
Arm Type
Sham Comparator
Arm Description
Neutral Control Task uses the same computer-based format as Attention Bias Modification Treatment, but includes only neutral stimuli and does not train attention.
Intervention Type
Behavioral
Intervention Name(s)
Attention Bias Modification Treatment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Neutral Control Task
Intervention Description
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 Outcome Measure Information:
Title
P1 amplitude elicited in the dot-probe task
Description
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.
Time Frame
post-intervention (within one week of completing the final treatment session)
Title
P1 amplitude elicited in the dot-probe task
Description
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.
Time Frame
Follow-up (six months after completing the final treatment session)
Secondary Outcome Measure Information:
Title
Liebowitz Social Anxiety Scale for Children and Adolescents
Description
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.
Time Frame
post-intervention (within one week of completing the final treatment session)
Title
Liebowitz Social Anxiety Scale for Children and Adolescents
Description
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.
Time Frame
Follow-up (six months after completing the final treatment session)
Title
Screen for Child Anxiety Related Emotional Disorders - Parent Version at posttreatment
Description
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.
Time Frame
7 days
Title
Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up
Description
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.
Time Frame
7 days
Title
Screen for Child Anxiety Related Emotional Disorders - Child Version at posttreatment
Description
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.
Time Frame
7 days
Title
Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up
Description
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.
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
State Anxiety before and after a Speech Task
Description
posttreatment State-Trait Anxiety Inventory for Children - State Subscale (STAIC-S) administered before and after a 3-minute speech task.
Time Frame
post-intervention (within one week of completing the final treatment session)
Title
State Anxiety before and after a Speech Task
Description
Follow-up State-Trait Anxiety Inventory for Children - State Subscale (STAIC-S) administered before and after a 3-minute speech task.
Time Frame
Follow-up (six months after completing the final treatment session)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy W Pettit, PhD
Phone
305-348-1671
Email
jpettit@fiu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy W Pettit, PhD
Organizational Affiliation
Florida International University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wendy K Silverman, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Child Study Center Program for Anxiety and Mood Disorders
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy K Silverman, PhD
Phone
203-737-7053
Email
wendy.silverman@yale.edu
Facility Name
Florida International University Center for Children and Families
City
Miami
State/Province
Florida
ZIP/Postal Code
33199
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Pettit, PhD
Phone
305-348-3879
Email
jpettit@fiu.edu
First Name & Middle Initial & Last Name & Degree
Jeremy Pettit, PhD
12. IPD Sharing Statement
Learn more about this trial
Targeting Attention Orienting to Social Threat to Reduce Social Anxiety in Youth
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