Gaze Contingent Feedback for Anxiety Disorders in Children

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03171363
• Other study ID #: TAUANX
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: September 2018
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease

Intervention

Behavioral:
• Gaze-contingent feedback
Participants will receive gaze-contingent feedback according to their viewing patterns

Locations

Country	Name	City	State
Israel	Tel Aviv University	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in anxiety symptoms - the Pediatric Anxiety Rating (PARS)	The PARS assesses global anxiety severity across different anxiety disorders in children	Post treatment (1 week after treatment completion)
Secondary	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.	Post treatment (1 week after treatment completion)