Altering High-risk Trajectories in Adolescent Anxiety Via Attention Bias Modification Training: Neural Predictors and Mechanisms (ABM Study)
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Western University, Canada
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change from baseline in parent-reported anxious symptoms at 3 weeks follow-up
Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- 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.
Eligibility Criteria
- Ages
- 11 Years to 13 Years (Child)
- Sex
- 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.
Outcomes
Primary Outcomes
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.
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.
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.
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.
Secondary Outcomes
- 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))
- Change from baseline in resting-state functional connectivity (rsFC)(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(6 weeks from baseline (after completing the 6th weekly training session))
Investigators
Elizabeth Hayden
Professor
Western University, Canada