Attention Bias Modification Treatment (ABMT) for Anxiety Disorders in Youth

Study Overview
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Brief Summary
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Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. Attention Bias Modification Treatment (ABMT) utilizes computer-based protocols to implicitly modify biased attentional patterns in anxious patients. This is a double-blind randomized controlled trial of ABMT for clinically anxious 10-18 year-olds. Participants will be assessed using clinical interviews and parent- and self-rated questionnaires before, in the middle and after twelve sessions of ABMT or control groups, and again at ten-week follow-up. Outcome measures will be anxiety symptoms and depression as measured by gold standard questionnaires as well as structured clinical interviews with youth and their parents. Attentional threat bias, Attentional control and interpretation of ambiguous information will also be measured to explore potential mediators of ABMT's effect on anxiety. The investigators expect the findings to inform pathways to treatments for anxious children and to provide initial information on mechanisms of ABMT efficacy.

Official Title
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Attention Bias Modification Treatment (ABMT) for Anxiety Disorders in Youth

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: Attention Bias Modification treatment (ABMT)
* Behavioral: Exposure only +ABMT
* Behavioral: Attention training only +ABMT
* Behavioral: Placebo group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary diagnosis of GAD, SOP, or SAD. Co-morbid attention deficit hyperactivity disorder (ADHD) or depressive disorders must be treated with medication and stable. Tics or impulse control problems must be treated with medication, stable and cause minimal or no impairment. Exclusion Criteria: To be excluded youth must: meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders, or Mental Retardation. show high likelihood of hurting themselves or others. have not been living with a primary caregiver who is legally able to give consent for the child's participation. be a victim of previously undisclosed abuse requiring investigation or ongoing supervision. be involved currently in another psycho-social treatment. have a serious vision problem that is not corrected with prescription lenses. have a physical disability that interferes with their ability to click a mouse button rapidly and repeatedly.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Attention Bias Modification treatment (ABMT)<br>Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli using threat and neutral face stimuli. | Behavioral: Attention Bias Modification treatment (ABMT)<br>* Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli using threat and neutral face stimuli.<br>|
| Active Comparator: Exposure only +ABMT<br>Identical discrimination task including exposure to a single threat or neutral face stimulus in each trial. | Behavioral: Exposure only +ABMT<br>* Identical discrimination task including exposure to a single threat or neutral face stimulus in each trial.<br>|
| Active Comparator: Attention training only +ABMT<br>Attention training via repeated trials of a dot-probe task using non-emotional stimuli. | Behavioral: Attention training only +ABMT<br>* Attention training via repeated trials of a dot-probe task using non-emotional stimuli.<br>|
| Placebo Comparator: Placebo group<br>Identical discrimination task including a single non-emotional stimulus in each trial. | Behavioral: Placebo group<br>* Identical discrimination task including a single non-emotional stimulus in each trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in anxiety symptoms - the Pediatric Anxiety Rating (PARS) | The PARS assesses global anxiety severity across different anxiety disorders in youth. | 4 weeks, 8 weeks, and 18 weeks (follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in anxiety related emotional disorders symptoms - Child/Parent Version (SCARED-C/P) | The SCARED is a 41-item self and parent-report instrument designed to assess anxiety in children and adolescents. | 4 weeks, 8 weeks, and 18 weeks (follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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attention training, attention bias modification treatment, anxiety disorders, clinical trials