COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Investigation of a Brief Psycho-Social Computerized Intervention Targeting the Error-Related Negativity and Balance N1 in Anxious Children

Quick Facts

Study Start:2022-10-12
Study Completion:2025-07-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05503017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:9 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * English-speaking child
  2. * Must be able to stand for 15 minutes without assistance
  3. * Anxiety disorder (generalized anxiety disorder, social anxiety disorder, and/or obsessive-compulsive disorder)
  1. * Depression or attention-deficit hyperactivity disorder
  2. * Significant medical condition, developmental disorder, or physical disability affecting the ability to stand
  3. * Severe psychopathology (e.g., bipolar disorder, psychosis, thought disorder, neurological disease, severe or extreme suicide risk)
  4. * Head injuries (over the past three months) that resulted in a loss of consciousness
  5. * Absence of an English-speaking primary caregiver that can accompany the child to the laboratory visit.

Contacts and Locations

Principal Investigator

Norman B Schmidt, PhD
PRINCIPAL_INVESTIGATOR
Florida State University

Study Locations (Sites)

FSU Psychology Building
Tallahassee, Florida, 32304
United States

Collaborators and Investigators

Sponsor: Florida State University

  • Norman B Schmidt, PhD, PRINCIPAL_INVESTIGATOR, Florida State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-12
Study Completion Date2025-07-16

Study Record Updates

Study Start Date2022-10-12
Study Completion Date2025-07-16

Terms related to this study

Additional Relevant MeSH Terms

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