Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT01191866
Status:
UNKNOWN
Last Update Posted:
2010-08-31
First Post:
2010-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychosocial Interventions in the Treatment of Youth With Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000083626', 'term': 'Psychosocial Intervention'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'lastUpdateSubmitDate': '2010-08-30', 'studyFirstSubmitDate': '2010-08-29', 'studyFirstSubmitQcDate': '2010-08-30', 'lastUpdatePostDateStruct': {'date': '2010-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'psychosocial', 'metabolic control', 'quality of life questionnaires', 'children', 'adolescents'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Primary Objective is to evaluate the influence of psychosocial interventions in the treatment of children and adolescents with type 1 diabetes mellitus by measuring the connection between these interventions to quality of life and to metabolic control. Secondary Objective is to provide an opportunity, through quality of life (QOL) questionnaires, for enhanced communication between the patient, family and diabetes care team and also an opportunity to resolve negative issues.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All children and adolescents with type 1 diabetes mellitus attending Assaf Harofeh Pediatric Diabetes Clinic will be eligible for inclusion in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children and adolescents with type 1 diabetes mellitus attending Assaf Harofeh Pediatric Diabetes Clinic will be eligible for inclusion in the study.'}, 'identificationModule': {'nctId': 'NCT01191866', 'briefTitle': 'Psychosocial Interventions in the Treatment of Youth With Type 1 Diabetes Mellitus', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Intensive Individual and Familial Psychosocial Interventions in the Treatment of Children and Adolescents With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '0406'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetes mellitus', 'description': 'All children and adolescents with type 1 diabetes mellitus attending Assaf Harofeh Pediatric Diabetes Clinic', 'interventionNames': ['Behavioral: psychosocial intervention']}], 'interventions': [{'name': 'psychosocial intervention', 'type': 'BEHAVIORAL', 'description': 'The interventions will include an art therapist, a social worker and volunteer work under the supervision of a diabetes nurse. These therapies will be given to selected patients based on individual needs. We will use existing questionnaires in order to identify problematic areas and quantify quality of life', 'armGroupLabels': ['Diabetes mellitus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Ẕerifin', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Shacham', 'role': 'CONTACT', 'email': 'shirashacham1@gmail.com'}, {'name': 'Shira Shacham, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assaf Harofeh Pediatric Diabetes Clinic', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr. Shira Shacham', 'oldOrganization': 'Assaf Harofeh Pediatric Diabetes Clinic'}}}}