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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
alan apter, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00482820
First received: June 4, 2007
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Anxiety
Behavioral: attention-bias training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • anxiety questionnaire - that are specified in the protocol. mood scale- as described in the protocol attention bias scores- as described in the protocol [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: July 2007
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00482820

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

No publications provided by Rabin Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: alan apter, Director, Feinberg Child Study Center and Department of Psychiatry, Schneider's Children's Medical Center of Israel, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00482820     History of Changes
Other Study ID Numbers: 4373
Study First Received: June 4, 2007
Last Updated: February 6, 2013
Health Authority: Israel: Ministry of Health
Israel: Ethics Commission

Keywords provided by Rabin Medical Center:
anxiety
attention-biases
children

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014