NCT03171363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

May 28, 2017

Last Update Submit

September 16, 2018

Conditions

Keywords

Attention bias modification treatmentAnxiety disordersAttention training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change from baseline in anxiety related emotional disorders symptoms - Child/Parent (the SCARED 41-item)

    Post treatment (1 week after treatment completion)

Study Arms (1)

Gaze-contingent feedback

EXPERIMENTAL

Participants will receive gaze-contingent feedback according to their viewing patterns

Behavioral: Gaze-contingent feedback

Interventions

Participants will receive gaze-contingent feedback according to their viewing patterns

Gaze-contingent feedback

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv University

Tel Aviv, 69978, Israel

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology and Neuroscience School of Psychological Sciences Sagol School of Neuroscience Tel Aviv University

Study Record Dates

First Submitted

May 28, 2017

First Posted

May 31, 2017

Study Start

April 1, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

September 18, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations