Attention Training to Modify Error-related Negativity and Risk for Anxiety in Adolescence

Anxiety Clinical Trial

Official title:

Attention Training to Modify Error-related Negativity and Risk for Anxiety in Adolescence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03176004
• Other study ID #: MH106477
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2021
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-site study to examine error-related brain activity (i.e., the error-related negativity) and anxiety symptoms in 11 to 14 year-olds (N=600) at two time points separated by two years. The study examines the degree to which error-related negativity can predict anxiety prospectively over two years, and whether a computerized game that alters attention to threat can alter error-related negativity and trajectories of anxiety.

Description:

Approximately 600 youths between the ages of 11 and 14 and their parents will be assessed. Adolescents will be evaluated at baseline using event-related potentials, self-report, and interview-based measures. The error-related negativity will be evaluated immediately (it takes less than 5 minutes to process and score a single subjects' error-related negativity ), and adolescents with good error-related negativity data (~90%, based on scorable error-related negativity data) will be randomly assigned to either an 8-week (i.e., 16 session) adaptive attention bias modification (N=180) or control condition (N=180) or a waitlist condition (N=180) group. Each session lasts 20 minutes, and participants will be asked to complete two 20-minute sessions per week. Participants will be assessed immediately at post, using the same measures from the baseline assessment. All participants will complete a 2-year follow-up lab visit using the same measures from the baseline assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 1, 2021
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

Inclusion Criteria:

• children and parent must speak English well enough to complete the study assessments

Exclusion Criteria:

• current threat of harm to self or others, bipolar illness, psychosis, thought disorder, pervasive developmental disorder, mental retardation, neurological diseases that impair cognition, or significant head injuries (past 3 months).

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• Attention Bias Modification
A computer game is used to facilitate attention away from threatening words.

Locations

Country	Name	City	State
United States	San Diego State University	San Diego	California
United States	Florida State University	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida State University	San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Anxiety Symptoms	Symptoms of Anxiety on the Screen for Child Anxiety Related Emotional Disorders (SCARED)	Baseline to 8 week
Primary	Change in Anxiety Symptoms	Symptoms of Anxiety on the Screen for Child Anxiety Related Emotional Disorders (SCARED)	baseline to 2 year follow-up