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Completed

NCT Number: NCT03176004

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Diego State University, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Attention bias modification

Other

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

Primary outcomes

  1. Change in Anxiety Symptoms

    Time frame: Baseline to 8 week

    Symptoms of Anxiety on the Screen for Child Anxiety Related Emotional Disorders (SCARED)

  2. Change in Anxiety Symptoms

    Time frame: baseline to 2 year follow-up

    Symptoms of Anxiety on the Screen for Child Anxiety Related Emotional Disorders (SCARED)

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • San Diego State University

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Jun 5, 2017
Registry last updated
Dec 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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