Using Attention Training to Reduce Adolescents' Anxious Symptoms (ABM)

April 25, 2023 updated by: Elizabeth Hayden, Western University, Canada

Altering High-risk Trajectories in Adolescent Anxiety Via Attention Bias Modification Training: Neural Predictors and Mechanisms (ABM Study)

During adolescence, youth undergo rapid developmental change and in some cases experience increases in worries and fearfulness, although the mechanisms that underlie this change are unclear. Previous studies indicate that heightened Attentional Bias (AB) toward threat-related cues may increase fearfulness, and it may be possible to change AB using a computerized, Attention Bias Modification task (ABM). This study will recruit healthy youth with elevated anxious symptoms to index attentional tendencies toward threat-related stimuli using cutting-edge techniques, and to test the effect of a computerized attention training task in altering attention to threatening cues. The investigators will also examine the role of ABM in changing youth's attention-related resting-state functional connectivity (rsFC), a neural marker of at-rest cognition.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Adolescence is a critical period for increases in anxious symptoms, potentially due to etiologically significant Attention Biases (AB) favoring threatening cues. However, the specific facets of AB that drive this vulnerability as well as their neurocognitive correlates are unclear, due in large part to the poor psychometric properties of the traditional assessment of AB in this field. By using both a standard behavioral task and a novel eye-tracking task, this study aims to unpack the nuanced facets of AB related to anxiety risks. Additionally, well-controlled Attentional Bias Modification (ABM) tasks designed to train attention away from threatening cues can be used to experimentally manipulate the causal mechanisms of interest, and to test whether ABM reduces symptoms and alters patterns of resting-state functional connectivity (rsFC, the intrinsic brain activity that occurs outside specific tasks) that characterize anxiety risks.

This study will recruit 60 11-13-year-old healthy adolescents with heightened anxious symptoms but without clinically significant anxiety disorders. They will be randomized to a six-session ABM training or a placebo task. Both before and after the training, the investigators will assess their anxious symptoms, AB, and rsFC. By examining the risk processes prior to the onset of clinically significant anxiety disorders, our work will make important new contributions to our understanding of how AB eventuates in anxiety and will have direct implications for early identification of youth at highest risk for anxiety disorders, and the targets that should be focused on in preventative efforts.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Elizabeth P Hayden, Ph.D
  • Phone Number: 519-661-3686
  • Email: ehayden@uwo.ca

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5B7
        • Western University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • English-speaking 11-13-year-old youth without significant medical, psychological, cognitive, or language impairments.

Exclusion Criteria:

  • Adolescents with clinically significant anxiety disorders or conditions in conflict with MRI scanning (e.g., orthodontics) will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Attentional Bias Modification (ABM) group
Participants in this arm will participate in a six-session ABM task, one session per week.
Behavioral: Attentional Bias Modification (ABM) task
Participants will be presented with a fixation cross (500ms) followed by a pair of identity-matched, angry-neutral faces (1000ms). The pair presentation is replaced by a single arrow-probe (1000ms) in the position of the neural face. Inter-trial intervals (ITI) are 500ms. Participants indicate arrow direction (left or right) by pressing one of two buttons as quickly as possible. By responding to the probe that always replaces the neutral face, participants learn to attend to the non-threat cues and away from threat cues. There are 120 trials of angry-neutral faces in total, and 40 other catch trials with neutral-neutral faces.
Placebo Comparator: Control group
Participants in this arm will participate in a six-session control task, one session per week.
Behavioral: Control task
The control task is identical with the ABM task, except that in the 120 angry-neutral trials, the arrow-probe replaces the angry face and the neutral face with equal probabilities (60 trials each).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in parent-reported anxious symptoms at 3 weeks follow-up
Time Frame: 3 weeks from baseline (after completing the 3rd weekly training session)
Parent-reported anxious symptoms will be assessed by the Child Behavior Checklist questionnaire. The anxious syndrome subscale will be used with a score summed across the 12 items of this subscale. Scores for each item range from 0 to 2, and scores for the subscale range from 0 to 24. Higher scores indicate greater anxious symptoms.
3 weeks from baseline (after completing the 3rd weekly training session)
Change from baseline in parent-reported anxious symptoms at 6 weeks follow-up
Time Frame: 6 weeks from baseline (after completing the 6th weekly training session)
Parent-reported anxious symptoms will be assessed by the Child Behavior Checklist questionnaire. The anxious syndrome subscale will be used with a score summed across the 12 items of this subscale. Scores for each item range from 0 to 2, and scores for the subscale range from 0 to 24. Higher scores indicate greater anxious symptoms.
6 weeks from baseline (after completing the 6th weekly training session)
Change from baseline in youth self-reported anxious symptoms at 3 weeks follow-up
Time Frame: 3 weeks from baseline (after completing the 3rd weekly training session)
Youth self-reported anxious symptoms will be assessed by the Youth Self Report questionnaire. The anxious syndrome subscale will be used with a score summed across the 12 items of this subscale. Scores for each item range from 0 to 2, and scores for the subscale range from 0 to 24. Higher scores indicate greater anxious symptoms.
3 weeks from baseline (after completing the 3rd weekly training session)
Change from baseline in youth self-reported anxious symptoms at 6 weeks follow-up
Time Frame: 6 weeks from baseline (after completing the 6th weekly training session)
Youth self-reported anxious symptoms will be assessed by the Youth Self Report questionnaire. The anxious syndrome subscale will be used with a score summed across the 12 items of this subscale. Scores for each item range from 0 to 2, and scores for the subscale range from 0 to 24. Higher scores indicate greater anxious symptoms.
6 weeks from baseline (after completing the 6th weekly training session)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in response-time-indexed Attentional Bias (AB) at 6 weeks follow-up
Time Frame: 6 weeks from baseline (after completing the 6th weekly training session)
This outcome will be assessed by a behavioral dot-probe task.
6 weeks from baseline (after completing the 6th weekly training session)
Change from baseline in eye-movement-indexed Attentional Bias (AB) at 6 weeks follow-up
Time Frame: 6 weeks from baseline (after completing the 6th weekly training session)
This outcome will be assessed by an eye-tracking task.
6 weeks from baseline (after completing the 6th weekly training session)
Change from baseline in resting-state functional connectivity (rsFC)
Time Frame: 6 weeks from baseline (after completing the 6th weekly training session)
rsFC will be assessed by resting-state functional magnetic resonance imaging (fMRI).
6 weeks from baseline (after completing the 6th weekly training session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 29, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Western HSREB #113928

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for outcome measures will be made available.

IPD Sharing Time Frame

Data will be available within 6 months of study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by the PI. Requests with the sole purpose of research will be approved. Requestors will be required to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety

Clinical Trials on Attentional Bias Modification (ABM) task

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings