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Computerized Psychosocial Intervention for Anxiety

N/A
Waitlist Available
Led By Alexandria Meyer, PhD
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow-up assessment (6-month follow-up)
Awards & highlights

Study Summary

This trial will be observing and testing the effects of a novel psychosocial intervention administered to both parents and children, which aims to normalize the error-related negativity (ERN) in children (i.e., reduce over-reactivity to making errors), in order to potentially mitigate risk for anxiety disorders.

Who is the study for?
This trial is for families with a child aged 5-7 who are highly sensitive to making errors, as shown by scoring high on the Child Error Sensitivity Index. A primary caregiver must be available to attend lab visits with the child, and both parent and child need to speak English.Check my eligibility
What is being tested?
The study tests a new psychosocial intervention aimed at normalizing children's brain activity in response to mistakes (reducing ERN). It involves 100 parent-child pairs, with most receiving the intervention and some in an active control group, comparing their anxiety symptoms before and after treatment.See study design
What are the potential side effects?
Since this is a psycho-social computerized intervention rather than medication, traditional side effects are not expected. However, participants may experience discomfort or stress during sessions that challenge their error sensitivity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow-up assessment (6-month follow-up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and follow-up assessment (6-month follow-up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Child anxiety symptoms at follow-up lab visit measured by the Screen for Child Anxiety Related Emotional Disorders (SCARED).
Initial Target Engagement: the error-related negativity (ERN, a physiological EEG measure) during the first lab visit
Target Engagement: the error-related negativity (ERN, a physiological EEG measure) at the follow-up lab visit

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Parent intervention and child controlExperimental Treatment1 Intervention
Parent will receive a computerized intervention to reduce error sensitivity and child will receive an active control (a computerized program targeting health behaviors).
Group II: Parent control and child interventionExperimental Treatment1 Intervention
Child will receive a computerized intervention to reduce error sensitivity and parent will receive an active control (a computerized program targeting health behaviors).
Group III: Parent and child interventionExperimental Treatment1 Intervention
Both parent and child will receive a computerized intervention to reduce error sensitivity.
Group IV: Parent and child controlActive Control1 Intervention
Both parent and child will receive an active control (a computerized program targeting health behaviors).

Find a Location

Who is running the clinical trial?

Florida State UniversityLead Sponsor
198 Previous Clinical Trials
30,464 Total Patients Enrolled
7 Trials studying Anxiety
1,956 Patients Enrolled for Anxiety
National Institute of Mental Health (NIMH)NIH
2,782 Previous Clinical Trials
2,688,885 Total Patients Enrolled
82 Trials studying Anxiety
38,878 Patients Enrolled for Anxiety
Alexandria Meyer, PhDPrincipal InvestigatorFlorida State University

Media Library

Psycho-social, computerized intervention targeting error sensitivity Clinical Trial Eligibility Overview. Trial Name: NCT04571814 — N/A
Anxiety Research Study Groups: Parent intervention and child control, Parent and child control, Parent control and child intervention, Parent and child intervention
Anxiety Clinical Trial 2023: Psycho-social, computerized intervention targeting error sensitivity Highlights & Side Effects. Trial Name: NCT04571814 — N/A
Psycho-social, computerized intervention targeting error sensitivity 2023 Treatment Timeline for Medical Study. Trial Name: NCT04571814 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrolment size for this research project?

"Affirmative. The information posted on clinicaltrials.gov reveals that this investigation is actively recruiting patients, having been first reported on September 1st 2020 and revised most recently on October 28th 2022. 175 participants are needed for the trial across a single medical centre."

Answered by AI

Are there any eligibility criteria for participation in this trial?

"175 participants are sought for this clinical trial, who must be between 5 and 7 years old and suffer from an anxiety disorder."

Answered by AI

Are there any slots still available to join this trial?

"According to the clinicaltrials.gov registry, this medical trial is still seeking volunteers. It was first published on September 1st 2020 and its most recent update was October 28th 2022."

Answered by AI

Does the research team accept individuals who are beyond the age of sixty to participate in this trial?

"Prerequisites for this clinical trial necessitate that applicants must be between 5 and 7 years old. There are 147 trials catered to individuals under 18, in addition to 440 studies dedicated to seniors aged 65 or above."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Florida State University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Targeting the ERN Computerized Intervention Targeting the Error-related Negativity in Young Children
Alexandria Meyer 2020. "Targeting the ERN Computerized Intervention Targeting the Error-related Negativity in Young Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04571814.
All > Generalized Anxiety Disorder
~0 spots leftby May 2024
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