Targeting Attention Orienting to Social Threat to Reduce Social Anxiety in Youth
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Jeremy W Pettit, PhD
- Phone Number: 305-348-1671
- Email: jpettit@fiu.edu
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale Child Study Center Program for Anxiety and Mood Disorders
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Florida
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Miami, Florida, United States, 33199
- Florida International University Center for Children and Families
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: Attention Bias Modification Treatment
Attention Bias Modification Treatment is a computer-based attention training program.
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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P1 Amplitude Elicited in the Dot-probe Task
Time Frame: post-intervention (within one week of completing the final treatment session)
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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.
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post-intervention (within one week of completing the final treatment session)
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P1 Amplitude Elicited in the Dot-probe Task
Time Frame: Follow-up (six months after completing the final treatment session)
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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.
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Follow-up (six months after completing the final treatment session)
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Liebowitz Social Anxiety Scale for Children and Adolescents
Time Frame: post-intervention (within one week of completing the final treatment session)
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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.
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post-intervention (within one week of completing the final treatment session)
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Liebowitz Social Anxiety Scale for Children and Adolescents
Time Frame: Follow-up (six months after completing the final treatment session)
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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.
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Follow-up (six months after completing the final treatment session)
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Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment
Time Frame: post-intervention (within one week of completing the final treatment session)
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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.
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post-intervention (within one week of completing the final treatment session)
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Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up
Time Frame: Follow-up (six months after completing the final treatment session)
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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.
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Follow-up (six months after completing the final treatment session)
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Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment
Time Frame: post-intervention (within one week of completing the final treatment session)
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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.
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post-intervention (within one week of completing the final treatment session)
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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.
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Follow-up (six months after completing the final treatment session)
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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State Anxiety Before a Speech Task
Time Frame: post-intervention (within one week of completing the final treatment session)
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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.
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post-intervention (within one week of completing the final treatment session)
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State Anxiety Before a Speech Task
Time Frame: Follow-up (six months after completing the final treatment session)
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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.
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Follow-up (six months after completing the final treatment session)
|
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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.
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post-intervention (within one week of completing the final treatment session)
|
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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.
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6 months after completing the final treatment session
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Jeremy W Pettit, PhD, Florida International University
- Principal Investigator: Wendy K Silverman, PhD, Yale University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- R01MH119299 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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