Trial Outcomes & Findings for Computerized Intervention Targeting the Error-Related Negativity and Balance N1 in Anxious Children (NCT NCT05503017)
NCT ID: NCT05503017
Last Updated: 2026-07-01
Results Overview
The change in magnitude of the error-related negativity between baseline and reassessment after the intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
248 participants
Primary outcome timeframe
1 hour
Results posted on
2026-07-01
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
|
Overall Study
COMPLETED
|
28
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
N=1 in the intervention condition made too few errors at the baseline time point to reliably measure the ERN.
Baseline characteristics by cohort
| Measure |
Intervention
n=28 Participants
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.
|
Control Condition
n=26 Participants
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.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
13 Participants
n=28 Participants
|
11 Participants
n=26 Participants
|
24 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=28 Participants
|
15 Participants
n=26 Participants
|
30 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=28 Participants
|
4 Participants
n=26 Participants
|
6 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=28 Participants
|
22 Participants
n=26 Participants
|
48 Participants
n=54 Participants
|
|
Age, Continuous
|
10.6 years
STANDARD_DEVIATION 1.1 • n=28 Participants
|
10.9 years
STANDARD_DEVIATION 1.2 • n=26 Participants
|
10.7 years
STANDARD_DEVIATION 1.2 • n=54 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=28 Participants
|
6 Participants
n=26 Participants
|
13 Participants
n=54 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=28 Participants
|
18 Participants
n=26 Participants
|
36 Participants
n=54 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=28 Participants
|
2 Participants
n=26 Participants
|
4 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=54 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=28 Participants
|
26 participants
n=26 Participants
|
54 participants
n=54 Participants
|
|
ERN amplitude
|
-13.6101 microvolts
STANDARD_DEVIATION 8.6475 • n=27 Participants • N=1 in the intervention condition made too few errors at the baseline time point to reliably measure the ERN.
|
-11.5400 microvolts
STANDARD_DEVIATION 7.6114 • n=26 Participants • N=1 in the intervention condition made too few errors at the baseline time point to reliably measure the ERN.
|
-12.5946 microvolts
STANDARD_DEVIATION 8.1445 • n=53 Participants • N=1 in the intervention condition made too few errors at the baseline time point to reliably measure the ERN.
|
|
Balance N1
|
-13.8436 microvolts
STANDARD_DEVIATION 17.7411 • n=28 Participants • 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.
|
-16.3534 microvolts
STANDARD_DEVIATION 20.2090 • n=24 Participants • 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.
|
-15.0020 microvolts
STANDARD_DEVIATION 18.7725 • n=52 Participants • 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.
|
PRIMARY outcome
Timeframe: 1 hourPopulation: 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).
The change in magnitude of the error-related negativity between baseline and reassessment after the intervention
Outcome measures
| Measure |
Intervention
n=26 Participants
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.
|
Control Condition
n=23 Participants
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.
|
|---|---|---|
|
Change in ERN After Intervention
|
3.4695 microvolts
Standard Deviation 9.4969
|
-0.2779 microvolts
Standard Deviation 6.3152
|
PRIMARY outcome
Timeframe: 1 hourPopulation: 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.
The change in magnitude of the error-related negativity between baseline and reassessment after the intervention
Outcome measures
| Measure |
Intervention
n=28 Participants
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.
|
Control Condition
n=22 Participants
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.
|
|---|---|---|
|
Change in Balance N1 After Intervention
|
-2.1217 microvolts
Standard Deviation 14.5040
|
-2.6097 microvolts
Standard Deviation 13.2976
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place