Gaze Contingent Feedback for Anxiety Disorders in Children

September 16, 2018 updated by: Yair Bar-Haim, Tel Aviv University

Gaze-Contingent Music Reward Treatment for Anxiety Disorders in Children: A Case Series

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel, 69978
        • Tel Aviv University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gaze-contingent feedback
Participants will receive gaze-contingent feedback according to their viewing patterns
Behavioral: Gaze-contingent feedback
Participants will receive gaze-contingent feedback according to their viewing patterns

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel Aviv University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

May 28, 2017

First Submitted That Met QC Criteria

May 30, 2017

First Posted (Actual)

May 31, 2017

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 16, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAUANX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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