Back to resultsGaze Contingent Feedback for Anxiety Disorders in Children
Primary Purpose
Anxiety Disorders
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Gaze-contingent feedback
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders focused on measuring Attention bias modification treatment, Anxiety disorders, Attention training
Eligibility Criteria
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.
Sites / Locations
- Tel Aviv University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gaze-contingent feedback
Arm Description
Participants will receive gaze-contingent feedback according to their viewing patterns
Outcomes
Primary Outcome Measures
Change from baseline in anxiety symptoms - the Pediatric Anxiety Rating (PARS)
The PARS assesses global anxiety severity across different anxiety disorders in children
Secondary Outcome Measures
Change from baseline in anxiety related emotional disorders symptoms - Child/Parent (the SCARED 41-item)
The SCARED is a 41-item self and parent-report instrument designed to assess anxiety in children.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03171363
Brief Title
Gaze Contingent Feedback for Anxiety Disorders in Children
Official Title
Gaze-Contingent Music Reward Treatment for Anxiety Disorders in Children: A Case Series
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
April 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv 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
The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of anxiety disorders in children.
Detailed Description
Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. The purpose of this study is to determine whether giving gaze-contingent feedback is an effective treatment for anxiety disorders in clinically anxious 6-10 year-olds children. Participants will be assessed using clinical interviews and parent- and self-rated questionnaires before and after eight training sessions. Outcome measures will be anxiety symptoms and depression as measured by gold standard questionnaires as well as structured clinical interviews with children and their parents. Attentional threat bias and Attentional control will also be measured to explore potential mediators of ABMT's effect on anxiety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Attention bias modification treatment, Anxiety disorders, Attention training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gaze-contingent feedback
Arm Type
Experimental
Arm Description
Participants will receive gaze-contingent feedback according to their viewing patterns
Intervention Type
Behavioral
Intervention Name(s)
Gaze-contingent feedback
Intervention Description
Participants will receive gaze-contingent feedback according to their viewing patterns
Primary Outcome Measure Information:
Title
Change from baseline in anxiety symptoms - the Pediatric Anxiety Rating (PARS)
Description
The PARS assesses global anxiety severity across different anxiety disorders in children
Time Frame
Post treatment (1 week after treatment completion)
Secondary Outcome Measure Information:
Title
Change from baseline in anxiety related emotional disorders symptoms - Child/Parent (the SCARED 41-item)
Description
The SCARED is a 41-item self and parent-report instrument designed to assess anxiety in children.
Time Frame
Post treatment (1 week after treatment completion)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Tel Aviv University
City
Tel Aviv
ZIP/Postal Code
69978
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
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Gaze Contingent Feedback for Anxiety Disorders in Children
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