NCT01397032

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2011

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

3.3 years

First QC Date

June 20, 2011

Last Update Submit

May 25, 2015

Conditions

Social Phobia

Keywords

attention bias modification treatmentcognitive bias modificationattention trainingsocial anxiety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Study Arms (2)

Attention Bias Modification (ABM)

EXPERIMENTAL

Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli.

Behavioral: Attention Bias Modification Treatment (ABMT)

Placebo

PLACEBO COMPARATOR

Attention training via repeated trials of a dot-probe task not intended to change threat-related attention patterns.

Behavioral: Attention Control Condition

Interventions

Attention Bias Modification Treatment (ABMT)BEHAVIORAL

Behavioral: Attention Bias Modification Treatment (ABMT) Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.

Attention Bias Modification (ABM)
Attention Control ConditionBEHAVIORAL

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

Placebo

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children suffering from social anxiety

You may not qualify if:

  • Pharmacological or Psychological treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel-Aviv University

Tel Aviv, Israel

Location

Related Publications (2)

  • 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.

    PMID: 20887977BACKGROUND

  • 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.

    PMID: 27435286DERIVED

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Yair Bar-Haim, PhD

    Tel Aviv University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Shcool of Psychological Sciences, Tel-Aviv University

Study Record Dates

First Submitted

June 20, 2011

First Posted

July 19, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

IL(1)