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

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Other: Attention Bias Modification

• Registration Number: NCT03176004
• Lead Sponsor: Florida State University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-05
• Primary Completion: 2020-01-01
• Status Verified: 2021-12
• Study Completion: 2021-12-01
• Last Update Submitted: 2021-12-17
• Last Update Posted: 2021-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Attention Bias Modification	Attention Bias Modification	Participants play a game in which they can move up in levels by reducing their reaction time to targets presented in the location of a threatening word.
Active Control Condition	Attention Bias Modification	Participants play a game in which they can move up in levels by reducing their reaction time to targets presented in the location of a word with a specific color.

Primary Outcome Measures

Name	Time	Method
Change in Anxiety Symptoms	baseline to 2 year follow-up	Symptoms of Anxiety on the Screen for Child Anxiety Related Emotional Disorders (SCARED)

Trial Locations

Locations (2)

San Diego State University; 🇺🇸 San Diego, California, United States

Florida State University; 🇺🇸 Tallahassee, Florida, United States