Computerized Intervention Targeting the Error-Related Negativity and Balance N1 in Anxious Children

NCT ID: NCT05503017

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-12
• Study Completion Date: 2025-07-16

Brief 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. 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.

Conditions

Anxiety Disorders; Generalized Anxiety Disorder; Social Anxiety Disorder; Obsessive-Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Intervention

Group Type: EXPERIMENTAL

Psycho-social, computerized intervention targeting error sensitivity

Intervention Type: 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.

Control Condition

Group Type: ACTIVE_COMPARATOR

Psycho-social, computerized intervention on healthy lifestyle choices

Intervention Type: BEHAVIORAL

The computer-based control condition will be 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Psycho-social, computerized intervention on healthy lifestyle choices

The computer-based control condition will be 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Norman Schmidt

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Norman B Schmidt, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

FSU Psychology Building

Tallahassee, Florida, United States

Countries

United States

Other Identifiers

1F32MH129076-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00003181

Identifier Type: -

Identifier Source: org_study_id