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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Other: Attention Bias Modification

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 Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92120
      • San Diego State University
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Florida State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Attention Bias Modification; A computer game is used to facilitate attention away from threatening words.
Active Comparator: Active Control Condition; 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.	Other: Attention Bias Modification; A computer game is used to facilitate attention away from threatening words.
No Intervention: Wait List; Participants simply return after 8 weeks.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: San Diego State University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): December 20, 2021
• Last Update Submitted That Met QC Criteria: December 17, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: MH106477

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data is being uploaded to the Research Domain Criteria Database, and will be available through National Institute of Mental Health Data Archive; the analyzed data yielded in our project, as specified in the same document (i.e., 12 months after accomplishment of each primary aim or objective, or immediately upon publication of the project's primary results, whichever occurs first).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No