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

NCT03176004 | Completed

• 1 other identifier: MH106477
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Attention Bias Modification

EXPERIMENTAL

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

Active Control Condition

ACTIVE COMPARATOR

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

Wait List

NO INTERVENTION

Participants simply return after 8 weeks.

Interventions

Attention Bias Modification OTHER

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

Active Control Condition; Attention Bias Modification

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children and parent must speak English well enough to complete the study assessments

You may not qualify if:

• 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).

Sponsors & Collaborators

• Florida State University: lead
• San Diego State University: collaborator

Study Sites (2)

San Diego State University

San Diego, California, 92120, United States

Location

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 5, 2017
• Study Start: October 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2021
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

US (2)