Attention Bias Modification Treatment for Children With Social Anxiety

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.

Study Overview

• Status: Completed
• Conditions: Social Phobia
• Intervention / Treatment: Behavioral: Attention Bias Modification Treatment (ABMT); Behavioral: Attention Control Condition

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Tel-Aviv, Israel
    • Tel-Aviv University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• children suffering from social anxiety

Exclusion Criteria:

• Pharmacological or Psychological treatment

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Disorders Interview Schedule for DSM-IV (ADIS)	The ADIS is a semi-structured interview assessing anxiety, mood and externalizing disorders in children according to DSM-IV criteria.	expected average time frame of 6 weeks. Participants will be assessed before and after the administriation of the training/control protocols.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Phobia and Anxiety Inventory for Children (SPAI-C) and for Parents (SPAI-c-p)	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.	expected average time frame of 6 weeks. Participants will be assessed before and after the administriation of the training/control protocols.

Collaborators and Investigators

• Sponsor: Tel Aviv University

Publications and helpful links

General Publications

• Hakamata Y, Lissek S, Bar-Haim Y, Britton JC, Fox NA, Leibenluft E, Ernst M, Pine DS. Attention bias modification treatment: a meta-analysis toward the establishment of novel treatment for anxiety. Biol Psychiatry. 2010 Dec 1;68(11):982-90. doi: 10.1016/j.biopsych.2010.07.021. Erratum In: Biol Psychiatry. 2012 Sep 1;72(5):429.
• Pergamin-Hight L, Pine DS, Fox NA, Bar-Haim Y. Attention bias modification for youth with social anxiety disorder. J Child Psychol Psychiatry. 2016 Nov;57(11):1317-1325. doi: 10.1111/jcpp.12599. Epub 2016 Jul 20.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: June 20, 2011
• First Submitted That Met QC Criteria: July 18, 2011
• First Posted (Estimate): July 19, 2011

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 25, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: social anxiety; attention training; cognitive bias modification; attention bias modification treatment
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobic Disorders; Phobia, Social
• Other Study ID Numbers: 2009340