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Attention Bias Modification Treatment for Children With Social Anxiety

This study is currently recruiting participants.
Verified July 2011 by Tel Aviv University
Sponsor:
Information provided by:
Tel Aviv University
ClinicalTrials.gov Identifier:
NCT01397032
First received: June 20, 2011
Last updated: July 18, 2011
Last verified: July 2011
History of Changes
  Purpose

Children with social anxiety will be randomly assigned to either Attention Bias Modification Treatment (ABMT) designed to direct attention away from threat or a placebo control condition not designed to change attention patterns. Outcome measures will be depression and social anxiety symptoms as measured by gold standard questionnaires as well as diagnosis of social phobia disorder and symptom counts derived from structured clinical interviews with children and their parents.

We expect to see significant reduction in social anxiety symptoms in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group.


Condition Intervention Phase
Social Phobia
 Behavioral: Attention Bias Modification Treatment (ABMT)
Behavioral: Attention Control Condition
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Attention Bias Modification Treatment for Children With Social Anxiety

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Phobias
U.S. FDA Resources

Further study details as provided by Tel Aviv University:

Primary Outcome Measures:
  • Anxiety Disorders Interview Schedule for DSM-IV (ADIS) [ Time Frame: expected average time frame of 6 weeks. Participants will be assessed before and after the administriation of the training/control protocols. ] [ Designated as safety issue: No ]
    The ADIS is a semi-structured interview assessing anxiety, mood and externalizing disorders in children according to DSM-IV criteria.


Secondary Outcome Measures:
  • Social Phobia and Anxiety Inventory for Children (SPAI-C) and for Parents (SPAI-c-p) [ Time Frame: expected average time frame of 6 weeks. Participants will be assessed before and after the administriation of the training/control protocols. ] [ Designated as safety issue: No ]
    The SPAI is a 26-item self and parent-report instrument designed to assess social anxiety in children and adolescents. Items assess a range of potentially anxiety-producing situations.


Estimated Enrollment: 120
Study Start Date: April 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Attention Bias Modification (ABM)
Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli.
 Behavioral: Attention Bias Modification Treatment (ABMT)
Behavioral: Attention Bias Modification Treatment (ABMT) Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.
Placebo Comparator: Placebo
Attention training via repeated trials of a dot-probe task not intended to change threat-related attention patterns.
 Behavioral: Attention Control Condition
Attention training using a computerized spatial attention task (dot-probe) not intended to alter threat-related attention patterns.

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children suffering from social anxiety

Exclusion Criteria:

  • Pharmacological or Psychological treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397032

Contacts
Contact: Yair Bar-Haim, PhD 972-3-6405465 yair1@post.tau.ac.il
Contact: Lee Pergamin-Hight, M.A. 972-52-2361038 leepergamin@gmail.com

Locations
Israel
Tel-Aviv University Recruiting
Tel-Aviv, Israel
Contact: Yair Bar-Haim, PhD         yair1@post.tau.ac.il    
Contact: Lee Pergamin-Hight, PhD         leepergamin@gmail.com    
Principal Investigator: Yair Bar-Haim, PhD            
Sub-Investigator: Lee Pergamin-Hight, MA            
Sponsors and Collaborators
Tel Aviv University
Investigators
Principal Investigator: Yair Bar-Haim, PhD Tel Aviv University
  More Information

Publications:

Responsible Party: Yair Bar-Haim / PI, Tel aviv university
ClinicalTrials.gov Identifier: NCT01397032     History of Changes
Other Study ID Numbers: 2009340
Study First Received: June 20, 2011
Last Updated: July 18, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Tel Aviv University:
attention bias modification treatment
cognitive bias modification
attention training
social anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013