ABM: Using Attention Training to Reduce Adolescents' Anxious Symptoms

Sponsor
Western University, Canada (Other)
Overall Status
Recruiting
CT.gov ID
NCT03973580
Collaborator
(none)
60
1
2
28.1
2.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Attentional Bias Modification (ABM) task
  • Behavioral: Control task
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Sixty adolescents will be randomly assigned to an active ABM task (n=30) or a control task (n=30) in parallel for the duration of the study.Sixty adolescents will be randomly assigned to an active ABM task (n=30) or a control task (n=30) in parallel for the duration of the study.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The randomized assignment procedure will be conducted solely by the PI. All other research staff and participants will be blind to the assigned condition throughout the course of the study. The PI will use a random number generator in Excel to assign a number 1-10 for each participant. The number will be given to the study coordinator, who notes the number in the participant's file. Participants will be assessed by the coordinator or other research staff. The research staff goes to each participant's home to conduct the ABM training protocol, where the number noted in this participant's file will be entered at the start of the training task to assign the participant to either the ABM task or the control task. The PI will not run the tasks. In communicating with participants, the terms baseline, outcome, and training will not be used.
Primary Purpose:
Basic Science
Official Title:
Altering High-risk Trajectories in Adolescent Anxiety Via Attention Bias Modification Training: Neural Predictors and Mechanisms (ABM Study)
Actual Study Start Date :
Jul 29, 2019
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in parent-reported anxious symptoms at 3 weeks follow-up [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.

  2. Change from baseline in parent-reported anxious symptoms at 6 weeks follow-up [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.

  3. Change from baseline in youth self-reported anxious symptoms at 3 weeks follow-up [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.

  4. Change from baseline in youth self-reported anxious symptoms at 6 weeks follow-up [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.

Secondary Outcome Measures

  1. Change from baseline in response-time-indexed Attentional Bias (AB) at 6 weeks follow-up [6 weeks from baseline (after completing the 6th weekly training session)]

    This outcome will be assessed by a behavioral dot-probe task.

  2. Change from baseline in eye-movement-indexed Attentional Bias (AB) at 6 weeks follow-up [6 weeks from baseline (after completing the 6th weekly training session)]

    This outcome will be assessed by an eye-tracking task.

  3. Change from baseline in resting-state functional connectivity (rsFC) [6 weeks from baseline (after completing the 6th weekly training session)]

    rsFC will be assessed by resting-state functional magnetic resonance imaging (fMRI).

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Western University London Ontario Canada N6A 5B7

Sponsors and Collaborators

  • Western University, Canada

Investigators

  • Principal Investigator: Elizabeth P Hayden, Ph.D, Western University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Elizabeth Hayden, Professor, Western University, Canada
ClinicalTrials.gov Identifier:
NCT03973580
Other Study ID Numbers:
  • Western HSREB #113928
First Posted:
Jun 4, 2019
Last Update Posted:
Oct 14, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elizabeth Hayden, Professor, Western University, Canada
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2020