Gaze Contingent Feedback for Anxiety Disorders in Children

Not Applicable

Completed

• Conditions: Anxiety Disorders
• Interventions: Behavioral: Gaze-contingent feedback

• Registration Number: NCT03171363
• Lead Sponsor: Tel Aviv University

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.

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-05-28
• Study First Submitted QC: 2017-05-30
• Study First Posted: 2017-05-31
• Primary Completion: 2018-04-01
• Study Completion: 2018-04-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-16
• Last Update Posted: 2018-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gaze-contingent feedback	Gaze-contingent feedback	Participants will receive gaze-contingent feedback according to their viewing patterns

Primary Outcome Measures

Name	Time	Method
Change from baseline in anxiety symptoms - the Pediatric Anxiety Rating (PARS)	Post treatment (1 week after treatment completion)	The PARS assesses global anxiety severity across different anxiety disorders in children

Secondary Outcome Measures

Name	Time	Method
Change from baseline in anxiety related emotional disorders symptoms - Child/Parent (the SCARED 41-item)	Post treatment (1 week after treatment completion)	The SCARED is a 41-item self and parent-report instrument designed to assess anxiety in children.

Trial Locations

Locations (1)

Tel Aviv University; 🇮🇱 Tel Aviv, Israel