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

NCT ID: NCT03176004

Last Updated: 2021-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2021-12-01

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.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Research assistants assign participants to condition; the investigator is unaware of the assignment. Participants are unaware of the distinction between ABM and CC, though they would know if they were in the wait list group.

Study Groups

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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.

Group Type EXPERIMENTAL

Attention Bias Modification

Intervention Type OTHER

A computer game is used to facilitate attention away from threatening words.

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.

Group Type ACTIVE_COMPARATOR

Attention Bias Modification

Intervention Type OTHER

A computer game is used to facilitate attention away from threatening words.

Wait List

Participants simply return after 8 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Attention Bias Modification

A computer game is used to facilitate attention away from threatening words.

Intervention Type OTHER

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).
Minimum Eligible Age

11 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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San Diego State University

OTHER

Sponsor Role collaborator

Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Greg Hajcak

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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San Diego State University

San Diego, California, United States

Site Status

Florida State University

Tallahassee, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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MH106477

Identifier Type: -

Identifier Source: org_study_id