Attention Bias Modification Treatment for Children With Social Anxiety

Sponsor

Tel Aviv University (Other)

Overall Status

Completed

CT.gov ID

NCT01397032

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Attention Bias Modification Treatment for Children With Social Anxiety

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Anxiety Disorders Interview Schedule for DSM-IV (ADIS) [expected average time frame of 6 weeks. Participants will be assessed before and after the administriation of the training/control protocols.]
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) [expected average time frame of 6 weeks. Participants will be assessed before and after the administriation of the training/control protocols.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

children suffering from social anxiety

Exclusion Criteria:

Pharmacological or Psychological treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tel-Aviv University	Tel-Aviv		Israel

Sponsors and Collaborators

Tel Aviv University

Investigators

Principal Investigator: Yair Bar-Haim, PhD, Tel Aviv University

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Yair Bar-Haim, Head of Shcool of Psychological Sciences, Tel-Aviv University, Tel Aviv University

ClinicalTrials.gov Identifier:

NCT01397032

Other Study ID Numbers:

2009340

First Posted:

Jul 19, 2011

Last Update Posted:

May 27, 2015

Last Verified:

May 1, 2015

Keywords provided by Yair Bar-Haim, Head of Shcool of Psychological Sciences, Tel-Aviv University, Tel Aviv University

attention bias modification treatment

cognitive bias modification

attention training

social anxiety

Additional relevant MeSH terms:

Phobia, Social

Study Results

No Results Posted as of May 27, 2015