Social Anxiety Disorder of Childhood
Conditions
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.
Interventions
BEHAVIORALAttention 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.
BEHAVIORALNeutral 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.
Sponsors
Florida International University
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| P1 Amplitude Elicited in the Dot-probe Task | 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liebowitz Social Anxiety Scale for Children and Adolescents | post-intervention (within one week of completing the final treatment session) | 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. |
| Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment | post-intervention (within one week of completing the final treatment session) | 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. |
| Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up | Follow-up (six months after completing the final treatment session) | 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. |
| Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment | post-intervention (within one week of completing the final treatment session) | 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. |
| Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJeremy W Pettit, PhD
Florida International University
PRINCIPAL_INVESTIGATORWendy K Silverman, PhD
Yale University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 11.82 age in years STANDARD_DEVIATION 1.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Liebowitz Social Anxiety Scale for Children and Adolescents | 100.66 units on a scale STANDARD_DEVIATION 22.92 |
| P1 amplitude elicited in the dot-probe task | 5.92 microvolts STANDARD_DEVIATION 4.75 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 29 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 146 Participants |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 105 | 0 / 101 |
| other Total, other adverse events | 0 / 105 | 0 / 101 |
| serious Total, serious adverse events | 0 / 105 | 0 / 101 |
Outcome results
None listed