A Clinical Research Studying a Method of Intervention for Children Diagnosed With Anxiety Disorder: Attentional Bias Intervention

Studies show that children with high levels of anxiety tend to pay more attention to threatening stimulus in the environment. They tend to attend to these stimuli and have difficulty to disengage from them. These attention biases enhance and maintain the level of anxiety. The aim of this study is to test a method of therapeutically intervention which focuses on shifting these attentional biases, with the use of a computer game which was designed to train the child to focus his/her attention away from the threatening stimuli and to focus on natural or positive stimuli. We will recruit 160 children with ongoing anxiety disorders who seek treatment. We will first assess threat-related attention bias and anxiety symptoms using structured psychiatric interviews and questionnaires. We will then randomly assign these children to one of four conditions: training to avoid threatening stimuli and attend to neutral stimuli; control placebo-training for threat-neutral stimuli; training to attend to positive stimuli and avoid neutral stimuli; and, control placebo-training for positive-neutral stimuli. Upon completion of training we will again assess attention bias and anxiety.

Two sets of predictions will be tested, one set concerns the effects of training on attention, and the other concerns the effects of training on anxiety. In terms of training effects on attention, we hypothesize that children with anxiety disorders can be trained to either avoid threat or attend to positive stimuli. In terms of training effects on anxiety symptoms, we hypothesize that the experimental training sessions will produce greater reduction in symptoms of anxiety than the placebo-control training sessions.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: attention-bias training

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children with Clinical diagnosis of Generalized Anxiety Disorder (GAD), Social Phobia (SP), or Separation Anxiety Disorder (SAD).

Exclusion Criteria:

• Children with the diagnoses of OCD, specific phobia, and PTSD in the absence of comorbid GAD, SP, or SAD.
• Other exclusion criteria include ongoing major depressive disorder, and use of psychotropic medication.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; attention training away from threat	Behavioral: attention-bias training; one group recive an attention training away from threat. The second group, the controll group, recive a placebo training
Placebo Comparator: 2; placebo attention training	Behavioral: attention-bias training; one group recive an attention training away from threat. The second group, the controll group, recive a placebo training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
anxiety questionnaire - that are specified in the protocol. mood scale- as described in the protocol attention bias scores- as described in the protocol	2-4 weeks

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Study Director: Bar-Haim Yair, Phd, Tel-aviv university; and schnider children's medical center of isreal

Publications and helpful links

General Publications

• Eldar S, Apter A, Lotan D, Edgar KP, Naim R, Fox NA, Pine DS, Bar-Haim Y. Attention bias modification treatment for pediatric anxiety disorders: a randomized controlled trial. Am J Psychiatry. 2012 Feb;169(2):213-20. doi: 10.1176/appi.ajp.2011.11060886.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: June 4, 2007
• First Submitted That Met QC Criteria: June 4, 2007
• First Posted (Estimate): June 5, 2007

Study Record Updates

• Last Update Posted (Estimate): February 7, 2013
• Last Update Submitted That Met QC Criteria: February 6, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: children; anxiety; attention-biases
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 4373