Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-30 @ 7:33 PM
Study NCT ID:
NCT01397032
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2011-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Attention Bias Modification Treatment for Children With Social Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072861', 'term': 'Phobia, Social'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-25', 'studyFirstSubmitDate': '2011-06-20', 'studyFirstSubmitQcDate': '2011-07-18', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety Disorders Interview Schedule for DSM-IV (ADIS)', 'timeFrame': 'expected average time frame of 6 weeks. Participants will be assessed before and after the administriation of the training/control protocols.', 'description': 'The ADIS is a semi-structured interview assessing anxiety, mood and externalizing disorders in children according to DSM-IV criteria.'}], 'secondaryOutcomes': [{'measure': 'Social Phobia and Anxiety Inventory for Children (SPAI-C) and for Parents (SPAI-c-p)', 'timeFrame': 'expected average time frame of 6 weeks. Participants will be assessed before and after the administriation of the training/control protocols.', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['attention bias modification treatment', 'cognitive bias modification', 'attention training', 'social anxiety'], 'conditions': ['Social Phobia']}, 'referencesModule': {'references': [{'pmid': '20887977', 'type': 'BACKGROUND', '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.'}, {'pmid': '27435286', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nWe expect to see significant reduction in social anxiety symptoms in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children suffering from social anxiety\n\nExclusion Criteria:\n\n* Pharmacological or Psychological treatment'}, 'identificationModule': {'nctId': 'NCT01397032', 'briefTitle': 'Attention Bias Modification Treatment for Children With Social Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Tel Aviv University'}, 'officialTitle': 'Attention Bias Modification Treatment for Children With Social Anxiety', 'orgStudyIdInfo': {'id': '2009340'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Attention Bias Modification (ABM)', 'description': 'Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli.', 'interventionNames': ['Behavioral: Attention Bias Modification Treatment (ABMT)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Attention training via repeated trials of a dot-probe task not intended to change threat-related attention patterns.', 'interventionNames': ['Behavioral: Attention Control Condition']}], 'interventions': [{'name': 'Attention Bias Modification Treatment (ABMT)', 'type': 'BEHAVIORAL', 'description': 'Behavioral: Attention Bias Modification Treatment (ABMT) Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.', 'armGroupLabels': ['Attention Bias Modification (ABM)']}, {'name': 'Attention Control Condition', 'type': 'BEHAVIORAL', 'description': 'Attention training using a computerized spatial attention task (dot-probe) not intended to alter threat-related attention patterns.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel-Aviv University', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Yair Bar-Haim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel Aviv University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel Aviv University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Shcool of Psychological Sciences, Tel-Aviv University', 'investigatorFullName': 'Yair Bar-Haim', 'investigatorAffiliation': 'Tel Aviv University'}}}}