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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety

Intervention / Treatment
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* Other: Attention Bias Modification


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Adolescents are randomized to either a game that trains attention away from threat (attention bias modification), a game that trains attention but unrelated to threat (control condition), or a wait list group.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |