Attention Training to Modify Error-related Negativity and Risk for Anxiety in Adolescence
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attention Bias Modification
Sponsored by
About this trial
This is an interventional basic science trial for Anxiety
Eligibility Criteria
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).
Sites / Locations
- San Diego State University
- Florida State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Attention Bias Modification
Active Control Condition
Wait List
Arm Description
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.
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.
Participants simply return after 8 weeks.
Outcomes
Primary Outcome Measures
Change in Anxiety Symptoms
Symptoms of Anxiety on the Screen for Child Anxiety Related Emotional Disorders (SCARED)
Change in Anxiety Symptoms
Symptoms of Anxiety on the Screen for Child Anxiety Related Emotional Disorders (SCARED)
Secondary Outcome Measures
Full Information
NCT ID
NCT03176004
First Posted
May 31, 2017
Last Updated
December 17, 2021
Sponsor
Florida State University
Collaborators
San Diego State University
1. Study Identification
Unique Protocol Identification Number
NCT03176004
Brief Title
Attention Training to Modify Error-related Negativity and Risk for Anxiety in Adolescence
Official Title
Attention Training to Modify Error-related Negativity and Risk for Anxiety in Adolescence
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
San Diego State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Attention Bias Modification
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Control Condition
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Wait List
Arm Type
No Intervention
Arm Description
Participants simply return after 8 weeks.
Intervention Type
Other
Intervention Name(s)
Attention Bias Modification
Intervention Description
A computer game is used to facilitate attention away from threatening words.
Primary Outcome Measure Information:
Title
Change in Anxiety Symptoms
Description
Symptoms of Anxiety on the Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time Frame
Baseline to 8 week
Title
Change in Anxiety Symptoms
Description
Symptoms of Anxiety on the Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time Frame
baseline to 2 year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Facility Information:
Facility Name
San Diego State University
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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).
Learn more about this trial
Attention Training to Modify Error-related Negativity and Risk for Anxiety in Adolescence
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