Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-30 @ 10:02 AM
Study NCT ID:
NCT01652651
Status:
UNKNOWN
Last Update Posted:
2012-07-30
First Post:
2012-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk and Resilience Factors in Learning Disabilities Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007859', 'term': 'Learning Disabilities'}], 'ancestors': [{'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-25', 'studyFirstSubmitDate': '2012-06-17', 'studyFirstSubmitQcDate': '2012-07-25', 'lastUpdatePostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Child Behavior Checklist (CBCL) (Achenbach, 1991).', 'timeFrame': 'base line (time 0) and end of treatment (3 month)', 'description': "The Child Behavior Checklist (CBCL) is a device by which parents and teachers rate a child's problem behaviors and competencies. It consists of 112 behavioral items (and 1 open-ended item) scored on a 3-step response scale from Not true (0) to Very true or Often true (2). Subscales include Aggressive Behavior, Anxious/Depressed, Attention Problems, Delinquent Rule-Breaking Behavior, Social Problems, Somatic Complaints, Thought Problems, Withdrawn, Externalizing, Internalizing, Total Problems, plus DSM-oriented scales."}], 'secondaryOutcomes': [{'measure': "Change in The standardized Brain Resource cognition assessment, ''IntegNeuro,'' (Clark et al., 2006).", 'timeFrame': 'base line (time 0) and end of treatment (3 month)', 'description': 'A computerized standardized assessment of Executive Functions and Continuous Performance Test'}]}, 'conditionsModule': {'keywords': ['Learning Disorders'], 'conditions': ['Learning Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to report preliminary outcomes of executive function and psychopathology symptoms of a manual-based psychological intervention for adolescents diagnosed with learning disorders- I can succeed (ICS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Learning Disorder diagnosis\n* Normal range IQ\n* Regular class attendance\n\nExclusion Criteria:\n\n* Suicidal ideation and psychosis'}, 'identificationModule': {'nctId': 'NCT01652651', 'briefTitle': 'Risk and Resilience Factors in Learning Disabilities Population', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'The Contribution of Risk and Resilience Factors in Learning Disabilities Population to Academic and Emotional Development', 'orgStudyIdInfo': {'id': '5383'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psychological Intervention', 'interventionNames': ['Behavioral: I Can Succeed ICS']}], 'interventions': [{'name': 'I Can Succeed ICS', 'type': 'BEHAVIORAL', 'description': 'ICS is a manual-based psychological intervention aimed to address both emotional and academic-executive functions aspects of LD.It consists of acute phase (13 once a week sessions) and follow-up phase (6 sessions over 18 months). ICS focuses on developing intrapersonal skills (e.g. self awareness, goal setting, organizational skills), interpersonal skills (e.g. communication, problem solving)and school/community skills (i.e. strengthening the family-school relationship) (Kopelman-Rubin et al., 2011).', 'armGroupLabels': ['Psychological Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49202', 'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Daphne Kopelman-Rubin, Ph.D', 'role': 'CONTACT', 'email': 'Daphnekr@idc.ac.il', 'phone': '+972-9-9549497'}], 'facility': 'Schneider Children Medical Center of Israel', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'Daphne Kopelman-Rubin, Ph.D', 'role': 'CONTACT', 'email': 'daphnekr@idc.ac.il', 'phone': '+972-9-9549497'}], 'overallOfficials': [{'name': 'Daphne Kopelman-Rubin, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Schneider's Children Medical Center of Israel"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}