Attention Bias Modification Treatment for Children With Social Anxiety
Primary Purpose
Social Phobia
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Attention Bias Modification Treatment (ABMT)
Attention Control Condition
Sponsored by
About this trial
This is an interventional basic science trial for Social Phobia focused on measuring attention bias modification treatment, cognitive bias modification, attention training, social anxiety
Eligibility Criteria
Inclusion Criteria:
- children suffering from social anxiety
Exclusion Criteria:
- Pharmacological or Psychological treatment
Sites / Locations
- Tel-Aviv University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Attention Bias Modification (ABM)
Placebo
Arm Description
Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli.
Attention training via repeated trials of a dot-probe task not intended to change threat-related attention patterns.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01397032
Brief Title
Attention Bias Modification Treatment for Children With Social Anxiety
Official Title
Attention Bias Modification Treatment for Children With Social Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia
Keywords
attention bias modification treatment, cognitive bias modification, attention training, social anxiety
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Attention Bias Modification (ABM)
Arm Type
Experimental
Arm Description
Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Attention training via repeated trials of a dot-probe task not intended to change threat-related attention patterns.
Intervention Type
Behavioral
Intervention Name(s)
Attention Bias Modification Treatment (ABMT)
Intervention Description
Behavioral: Attention Bias Modification Treatment (ABMT) Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.
Intervention Type
Behavioral
Intervention Name(s)
Attention Control Condition
Intervention Description
Attention training using a computerized spatial attention task (dot-probe) not intended to alter threat-related attention patterns.
Primary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule for DSM-IV (ADIS)
Description
The ADIS is a semi-structured interview assessing anxiety, mood and externalizing disorders in children according to DSM-IV criteria.
Time Frame
expected average time frame of 6 weeks. Participants will be assessed before and after the administriation of the training/control protocols.
Secondary Outcome Measure Information:
Title
Social Phobia and Anxiety Inventory for Children (SPAI-C) and for Parents (SPAI-c-p)
Description
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.
Time Frame
expected average time frame of 6 weeks. Participants will be assessed before and after the administriation of the training/control protocols.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children suffering from social anxiety
Exclusion Criteria:
Pharmacological or Psychological treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yair Bar-Haim, PhD
Organizational Affiliation
Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel-Aviv University
City
Tel-Aviv
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
20887977
Citation
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.
Results Reference
background
PubMed Identifier
27435286
Citation
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.
Results Reference
derived
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Attention Bias Modification Treatment for Children With Social Anxiety
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