Attention Bias Modification Treatment for Children With Social Anxiety

Social Phobia Clinical Trial

Official title:

Attention Bias Modification Treatment for Children With Social Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01397032
• Other study ID #: 2009340
• Status: Completed
• Phase: Phase 2
• First received: June 20, 2011
• Last updated: May 25, 2015
• Start date: April 2011
• Est. completion date: August 2014

Study information

• Verified date: May 2015
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 18 Years

Eligibility

Inclusion Criteria:

• children suffering from social anxiety

Exclusion Criteria:

• Pharmacological or Psychological treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Social Phobia

Intervention

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.
• Attention Control Condition
Attention training using a computerized spatial attention task (dot-probe) not intended to alter threat-related attention patterns.

Locations

Country	Name	City	State
Israel	Tel-Aviv University	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No