Anxiety DisordersNCT05503017
Computerized Intervention Targeting the Error-Related Negativity and Balance N1 in Anxious Children
A study testing Psycho-social, computerized intervention targeting error sensitivity and Psycho-social, computerized intervention on healthy lifestyle choices in people with Anxiety Disorders and Generalized Anxiety Disorder, run by Florida State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Anxiety Disorders, Generalized Anxiety Disorder, Social Anxiety Disorder
- What is being tested?
- Psycho-social, computerized intervention targeting error sensitivity and Psycho-social, computerized intervention on healthy lifestyle choices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2022to 16 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- English-speaking child
- Must be able to stand for 15 minutes without assistance
- Anxiety disorder (generalized anxiety disorder, social anxiety disorder, and/or obsessive-compulsive disorder)
Who cannot join
- Depression or attention-deficit hyperactivity disorder
- Significant medical condition, developmental disorder, or physical disability affecting the ability to stand
- Severe psychopathology (e.g., bipolar disorder, psychosis, thought disorder, neurological disease, severe or extreme suicide risk)
- Head injuries (over the past three months) that resulted in a loss of consciousness
- Absence of an English-speaking primary caregiver that can accompany the child to the laboratory visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation of a Brief Psycho-Social Computerized Intervention Targeting the Error-Related Negativity and Balance N1 in Anxious Children
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.
Read more
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.
- Conditions
- Anxiety Disorders, Generalized Anxiety Disorder, Social Anxiety Disorder, Obsessive-Compulsive Disorder
- Being tested
- Psycho-social, computerized intervention targeting error sensitivity, Psycho-social, computerized intervention on healthy lifestyle choices
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder, Phobia, Social, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-social, computerized intervention targeting error sensitivityBehavioural
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.
Psycho-social, computerized intervention on healthy lifestyle choicesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Psycho-social, computerized intervention targeting error sensitivity |
| Control Condition | Active comparator | Not described Receives: Behavioral: Psycho-social, computerized intervention on healthy lifestyle choices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ERN After Intervention
The change in magnitude of the error-related negativity between baseline and reassessment after the intervention
Measured: 1 hour
Change in Balance N1 After Intervention
The change in magnitude of the error-related negativity between baseline and reassessment after the intervention
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start12 Oct 2022
- Primary completion16 Jul 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Norman Schmidt, Florida State University
- Investigators
- Norman B Schmidt, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503017
- Sponsor's protocol ID
- STUDY00003181
- Other IDs
- 1F32MH129076-01A1
- Status last verified
- Jun 2026
- First submitted
- 10 Aug 2022
- Last updated
- 1 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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 Nov 1;412:122125. doi: 10.1016/j.jad.2026.122125. Epub 2026 Jun 12.
PubMed 42285525
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of a Brief Psycho-Social Computerized Intervention Targeting the Error-Related Negativity and Balance N1 in Anxious Children
- ClinicalTrials.gov ID
- NCT05503017
- Acronym / sponsor ID
- STUDY00003181
- Conditions
- Anxiety Disorders, Generalized Anxiety Disorder, Social Anxiety Disorder, Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 16 Aug 2022 (actual)
- Results
- Posted 1 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Psycho-social, computerized intervention targeting error sensitivity |
| Control Condition | Active comparator | Behavioral: Psycho-social, computerized intervention on healthy lifestyle choices |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- English-speaking child
- Must be able to stand for 15 minutes without assistance
- Anxiety disorder (generalized anxiety disorder, social anxiety disorder, and/or obsessive-compulsive disorder)
Key exclusion criteria (5 listed)
- Depression or attention-deficit hyperactivity disorder
- Significant medical condition, developmental disorder, or physical disability affecting the ability to stand
- Severe psychopathology (e.g., bipolar disorder, psychosis, thought disorder, neurological disease, severe or extreme suicide risk)
- Head injuries (over the past three months) that resulted in a loss of consciousness
- Absence of an English-speaking primary caregiver that can accompany the child to the laboratory visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psycho-social, computerized intervention targeting error sensitivityThe 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. | Behavioural | Intervention |
| Psycho-social, computerized intervention on healthy lifestyle choicesThe 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. | Behavioural | Control Condition |
Primary outcome
Change in ERN After Intervention
Time frame: 1 hour
The change in magnitude of the error-related negativity between baseline and reassessment after the intervention
Change in Balance N1 After Intervention
Time frame: 1 hour
The change in magnitude of the error-related negativity between baseline and reassessment after the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42285525Payne 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 Nov 1;412:122125. doi: 10.1016/j.jad.2026.122125. Epub 2026 Jun 12.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Anxiety Disorders
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Recruiting
Stress and Anxiety Effects on Valuation
Reward Value Level
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman B Schmidt, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psycho-social, computerized intervention targeting error sensitivity and Psycho-social, computerized intervention on healthy lifestyle choices in people with Anxiety Disorders and Generalized Anxiety Disorder, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ERN After Intervention (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05503017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.