Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1F32MH129076-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Anxiety disorders are the most common form of psychopathology, and frequently begin in childhood, resulting in lifelong impairment. Increased brain activity after making mistakes, as reflected by the error-related negativity (ERN), is observed in people with anxiety disorders, even before disorder onset. The ERN is therefore of great interest as a potentially modifiable risk factor for anxiety. However, methodological issues can make the ERN difficult to measure.
Increased brain activity in response to a balance disturbance, as reflected by the balance N1, resembles the ERN, but does not share its methodological issues. The investigators' preliminary data demonstrate that the balance N1 and the ERN are associated in amplitude in adults, suggesting they may depend on the same brain processes. The balance N1 has never been investigated in individuals with anxiety disorders, but it increases in amplitude within individuals under anxiety-inducing environmental contexts. Further, balance and anxiety are related in terms of brain anatomy, daily behavior, disorder presentation, and response to treatment.
The present investigation will measure the ERN and the balance N1 in children (ages 9-12) with anxiety disorders, and further, how these brain activity measures change in response to a brief, 45-minute, computerized psychosocial intervention that was developed to reduce reactivity to errors, and has been shown to reduce the ERN. The investigators will recruit approximately 80 children with anxiety disorders, half of whom will be randomly assigned to the active intervention condition. The other half will be assigned to an active control condition, consisting of a different 45-minute computerized presentation. Participants assigned to the control condition can access the computerized intervention after participation in the study.
The purpose of this investigation is to test the hypothesis that the balance N1 and the ERN will be reduced to a similar extent after the intervention, to demonstrate that these brain responses arise from shared brain processes. Transfer of the effect of the psycho-social intervention to the balance N1 would provide insight into prior work demonstrating that balance training can alleviate anxiety in young children, and well-documented benefits of psychotherapy to balance disorders. Collectively, these data may guide the development of multidisciplinary interventions for the prevention and treatment of anxiety disorders in children.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| Control Condition | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psycho-social, computerized intervention targeting error sensitivity | Behavioral | The computer-based intervention is designed to directly reduce the sensitivity to errors through cognitive behavioral techniques. The intervention takes approximately 45 minutes and includes interactive quizzes, information, and behavioral tasks relevant to making mistakes, implications of making errors, and ways to deal with making mistakes, among other topics relevant to increased error sensitivity. The intervention uses developmentally appropriate language and stories that young children can relate to and understand. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ERN After Intervention | The change in magnitude of the error-related negativity between baseline and reassessment after the intervention | 1 hour |
| Change in Balance N1 After Intervention | The change in magnitude of the error-related negativity between baseline and reassessment after the intervention | 1 hour |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Norman B Schmidt, PhD | Florida State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FSU Psychology Building | Tallahassee | Florida | 32304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42285525 | Derived | Payne AM, Schmidt NB, Meyer A, Hajcak G. A psychosocial manipulation of the error-related negativity does not transfer to the balance N1: A randomized controlled trial in anxious children. J Affect Disord. 2026 Jun 12:122125. doi: 10.1016/j.jad.2026.122125. Online ahead of print. |
Not provided
Not provided
The study protocol and statistical analysis plan will be available as posted on clinicaltrials.gov upon posting of summary results information (i.e., within 1 year of study completion). Deidentified data dictionaries will also be made publicly available upon posting of summary results information. The data dictionaries (in the form of a spreadsheet) will include at least the following: age, sex, assignment to intervention or control condition, and baseline and reassessment amplitudes of both the ERN and the balance N1. The processed waveforms from which the ERN and balance N1 amplitudes are measured will also be made publicly available in a ".mat" file, viewable in MATLAB. Once these are posted, the associated access link will be updated here.
Available upon posting of summary results information within 1 year of study completion.
Publicly available
Not provided
N=182 children did not meet criteria for inclusion. N=6 children/families were found to be eligible, but declined to participate or were otherwise unable to schedule their study visit.
Families were recruited from the community surrounding Florida State University. Child eligibility was determined by phone interview of a parent/guardian using the Kiddle Schedule for Affective Disorders and Schizophrenia interview. Eligible children met DSM-5 criteria for generalized anxiety disorder, social anxiety disorder, and/or obsessive-compulsive disorder, and did not meet DSM-5 criteria for depression or attention-deficit hyperactivity disorder.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Psycho-social, computerized intervention targeting error sensitivity: The computer-based intervention is designed to directly reduce the sensitivity to errors through cognitive behavioral techniques. The intervention takes approximately 45 minutes and includes interactive quizzes, information, and behavioral tasks relevant to making mistakes, implications of making errors, and ways to deal with making mistakes, among other topics relevant to increased error sensitivity. The intervention uses developmentally appropriate language and stories that young children can relate to and understand. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 5, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Psycho-social, computerized intervention on healthy lifestyle choices | Behavioral | The computer-based control condition is in the same format and duration as the active intervention, but instead focuses on self-care topics and healthy lifestyle choices (e.g., eating healthy foods and getting a good night sleep), unrelated to error sensitivity. |
|
| FG001 | Control Condition | Psycho-social, computerized intervention on healthy lifestyle choices: The computer-based control condition is in the same format and duration as the active intervention, but instead focuses on self-care topics and healthy lifestyle choices (e.g., eating healthy foods and getting a good night sleep), unrelated to error sensitivity. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Psycho-social, computerized intervention targeting error sensitivity: The computer-based intervention is designed to directly reduce the sensitivity to errors through cognitive behavioral techniques. The intervention takes approximately 45 minutes and includes interactive quizzes, information, and behavioral tasks relevant to making mistakes, implications of making errors, and ways to deal with making mistakes, among other topics relevant to increased error sensitivity. The intervention uses developmentally appropriate language and stories that young children can relate to and understand. |
| BG001 | Control Condition | Psycho-social, computerized intervention on healthy lifestyle choices: The computer-based control condition is in the same format and duration as the active intervention, but instead focuses on self-care topics and healthy lifestyle choices (e.g., eating healthy foods and getting a good night sleep), unrelated to error sensitivity. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| ERN amplitude | N=1 in the intervention condition made too few errors at the baseline time point to reliably measure the ERN. | Mean | Standard Deviation | microvolts |
| ||||||||||||||
| Balance N1 | and N=2 individuals (control condition) were excluded from analyses because they performed the balance task with excessive load forces (protocol deviation) due to an issue with the live display of the load forces. | Mean | Standard Deviation | microvolts |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in ERN After Intervention | The change in magnitude of the error-related negativity between baseline and reassessment after the intervention | 4 individuals were excluded from analyses (2 intervention, 2 control) due to making too few (<6) errors to reliably measure the ERN. 1 individual (control) was excluded from analyses due to being identified as an extreme value (i.e., baseline ERN amplitude more than 3 standard deviations from the mean). | Posted | Mean | Standard Deviation | microvolts | 1 hour |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change in Balance N1 After Intervention | The change in magnitude of the error-related negativity between baseline and reassessment after the intervention | N=1 participant (control condition) asked not to complete the second iteration of the balance task, a data save failure occurred at the post time point for the balance task in N=1 participant (control condition), and N=2 individuals (control condition) were excluded from analyses because they performed the balance task with excessive load forces (protocol deviation) due to an issue with the live display of the load forces. | Posted | Mean | Standard Deviation | microvolts | 1 hour |
|
Duration of in-person lab visit, 2-3 hours.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Psycho-social, computerized intervention targeting error sensitivity: The computer-based intervention is designed to directly reduce the sensitivity to errors through cognitive behavioral techniques. The intervention takes approximately 45 minutes and includes interactive quizzes, information, and behavioral tasks relevant to making mistakes, implications of making errors, and ways to deal with making mistakes, among other topics relevant to increased error sensitivity. The intervention uses developmentally appropriate language and stories that young children can relate to and understand. | 0 | 28 | 0 | 28 | 0 | 28 |
| EG001 | Control Condition | Psycho-social, computerized intervention on healthy lifestyle choices: The computer-based control condition is in the same format and duration as the active intervention, but instead focuses on self-care topics and healthy lifestyle choices (e.g., eating healthy foods and getting a good night sleep), unrelated to error sensitivity. | 0 | 26 | 0 | 26 | 0 | 26 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aiden Payne | Ohio University | 740-593-4198 | ampayne@ohio.edu |
| Jun 5, 2026 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000098647 | Generalized Anxiety Disorder |
| D000072861 | Phobia, Social |
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
Not provided
Not provided
|
|
|
|
|
|
|
|
|