Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-01-02 @ 2:32 AM
Study NCT ID:
NCT00246792
Status:
UNKNOWN
Last Update Posted:
2006-02-17
First Post:
2005-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhancing Self-Understanding and Social Integration of Middle School Students With Learning Disabilities
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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-11', 'completionDateStruct': {'date': '2006-12'}, 'lastUpdateSubmitDate': '2006-02-16', 'studyFirstSubmitDate': '2005-10-28', 'studyFirstSubmitQcDate': '2005-10-28', 'lastUpdatePostDateStruct': {'date': '2006-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child Behaviour Checklist (Achenbach, 2001)'}, {'measure': 'Youth Report Form (Achenbach, 2001)'}, {'measure': 'Teacher Report Form (Achenbach, 2001)'}], 'secondaryOutcomes': [{'measure': 'Self-Perception Profile for Children (Harter, 1985)'}, {'measure': "The Children's Loneliness Questionnaire (Asher & Wheeler, 1985)"}, {'measure': 'The Self Advocacy Interview for Students (Brunello-Prudencio, 2001)'}, {'measure': 'Qualitative interviews with selected participants'}]}, 'conditionsModule': {'keywords': ['School-based intervention', 'Learning disabilities', 'ecological intervention'], 'conditions': ['Learning Disability']}, 'descriptionModule': {'briefSummary': "Research and intervention programs for students with learning disabilities (LD) typically address child and family characteristics without examining the school context and conditions that affect adjustment. Focusing on the student with LD can highlight the child and family's deficits. An ecological theoretical framework guides this research project, a collaboration of the University of Toronto, Faculty of Social Work and Ontario Institute for Studies in Education of the University of Toronto (OISE/UT), Integra and the Toronto Catholic District School Board. This framework is based on the assumption that people are very much part of and affected by social and environmental settings. Accordingly, it is important not to see the adjustment problems of children with LD as being caused only by their LD. Instead, their academic and social problems are seen as unfolding in larger circumstances that include other children, the classroom, the school, the family and the community. These many factors act together to influence the child with LD and must be taken into account along with individual characteristics of the child.", 'detailedDescription': 'Objectives\n\n1. Deliver an ecologically informed school-based intervention that addresses individual, social and environmental factors, to improve the adjustment of students with LD\n2. Examine the efficacy of the intervention\n3. Contribute to knowledge of the factors that influence the adjustment of students with LD\n4. Circulate this information to those who live and work with students with LD in order to offer understanding and direction for programs and interventions and to facilitate cross-sector collaboration\n\nThe research will utilize both quantitative and qualitative methodologies. 6 schools will be selected. 3 will receive the intervention in year 1 (2004-2005 school year), comprising 1) group treatment, 2) workshops, and 3) consultation. The other 3 schools will be controls in year 1 and receive the intervention in year 2 (2005-2006 school year).\n\nStudents in grades 6-8, identified as having LD will be offered the opportunity to participate in the project (with parental consent). This project comprises 3 components:\n\n1. School-based group treatment for students in grades 6-8 with LD and psychosocial problems. Group treatment will focus on assisting participants to understand the impact of their LD as well as on development of self-advocacy skills.\n2. Workshops on understanding LD for teachers, parents, and students without LD (grades 6-8).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Grades 6-8 with identified LD\n* Must demonstrate need for psychosocial intervention based on results on measures\n\nExclusion Criteria:\n\n* Cannot meet criteria for conduct disorder on the Teacher Report Form'}, 'identificationModule': {'nctId': 'NCT00246792', 'briefTitle': 'Enhancing Self-Understanding and Social Integration of Middle School Students With Learning Disabilities', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'Enhancing Self-Understanding and Social Integration of Middle School Students With Learning Disabilities', 'orgStudyIdInfo': {'id': '14596'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Group treatment', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S 1A1', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Faye Mishna, PhD', 'role': 'CONTACT', 'email': 'f.mishna@utoronto.ca', 'phone': '(4126) 978-1385'}, {'name': 'Joanne Daciuk', 'role': 'CONTACT', 'email': 'joanne.daciuk@utoronto.ca', 'phone': '(416) 978-5720'}], 'facility': 'University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Faye Mishna, PhD', 'role': 'CONTACT', 'email': 'f.mishn@utoronto.ca', 'phone': '(416) 978-1385'}, {'name': 'Barbara Muskat, MSW', 'role': 'CONTACT', 'email': 'bmuskat@integra.on.ca', 'phone': '(416) 486-8055', 'phoneExt': '227'}], 'overallOfficials': [{'name': 'Faye Mishna, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Social Sciences and Humanities Research Council of Canada', 'class': 'OTHER'}, {'name': 'Integra LifeSciences Corporation', 'class': 'INDUSTRY'}]}}}