Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-05 @ 3:48 AM
Study NCT ID:
NCT00622856
Status:
COMPLETED
Last Update Posted:
2018-05-15
First Post:
2008-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-09', 'studyFirstSubmitDate': '2008-02-13', 'studyFirstSubmitQcDate': '2008-02-13', 'lastUpdatePostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'Every three months'}, {'measure': 'adherence to treatment', 'timeFrame': 'before the intervention, after the intervention and at the end of the study'}, {'measure': 'consumption of health services', 'timeFrame': 'during the study and at the end of the study'}], 'secondaryOutcomes': [{'measure': 'Changes in the wellbeing of adolescents and their parents', 'timeFrame': 'In the beginning of the study, at the end of the intervention and after 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'adolescents', 'psychological therapy'], 'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '23479303', 'type': 'DERIVED', 'citation': 'Yackobovitch-Gavan M, Meshy-Tamir R, Nagelberg N, Phillip M, Meyerovitch J. Psychosocial factors associated with depressive mood in Israeli obese adolescents. J Health Psychol. 2014 Apr;19(4):574-84. doi: 10.1177/1359105313475901. Epub 2013 Mar 11.'}]}, 'descriptionModule': {'briefSummary': "A three arms, open, randomized interventional study including 100 participants in order to evaluate the cost-efficacy of psychological intervention for strengthening parental authority among parents of diabetic adolescents with poor glycemic control.\n\nAll participants will be randomized into three groups:1.The first group will get a psychological treatment in order to strengthen the parent's authority. 2.The second group will get an education of a nurse and a dietician. 3.The third group will serve as a control group and will not go through an intervention.\n\nThe following data will be analyzed during the study: 1.Changes in HbA1c. 2.Changes in parents authority. 3.Changes in the diabetes treatment by the adolescents. 4.Consumption of health services. 5.The costs of all psychological treatments.", 'detailedDescription': "A three arms, open, randomized interventional study including 100 participants in order to evaluate the cost-efficacy of psychological intervention for strengthening parental authority among parents of diabetic adolescents with poor glycemic control.\n\nObjectives:\n\n1. The primary purpose of the study is to evaluate the immediate effectiveness and the long run effectiveness of psychological intervention for strengthening parental authority among parents of diabetic adolescents with poor glycemic control.\n2. To evaluate the cost as appose to the benefit of the psychological intervention.\n3. To characterize the different variables in parent's attitude that improve their children's glycemic control.\n4. To develop a therapy model for strengthening parent's authority which will be suitable for parents of diabetic adolescents.\n\nStudy design:\n\nAll participants in the study will be randomized to three different groups:\n\n1. A treatment group that will go through psychological treatment to strengthen the parents authority.\n2. A control group that will get an education of a nurse and a dietician\n3. A control group that will not get any intervention. All groups will include parents of diabetic adolescents with poor glycemic control.\n\nThe following data will be analyzed during the study:\n\n1. Changes in glycemic control will be measured by levels of HbA1C.\n2. Changes in the diabetes treatment by the adolescents will be measured by adherence to insulin injections, the number of times a day in which the patient checked his blood glucose values, number of visits in the clinic and psychological questionnaires.\n3. Consumption of health services\n4. Changes in parents attitude and changes in the wellbeing of the diabetic adolescents and their parents will be based on questionnaires."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Parents of adolescents between the ages of 10-18\n2. More than one year diabetes\n3. Adolescent's HbA1c\\>8\n\nExclusion Criteria:\n\n1. Adolescents or parents of adolescents that are mentally retarded.\n2. Another chronic disease besides diabetes.\n3. Adolescents that are taking medications that might disturb their glycemic control."}, 'identificationModule': {'nctId': 'NCT00622856', 'briefTitle': 'The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control', 'orgStudyIdInfo': {'id': 'rmc004377ctil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Psychological intervention for strengthening parental authority', 'interventionNames': ['Behavioral: psychological intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Diabetes education- 5 sessions with diabetes nurse, taking place once a week', 'interventionNames': ['Behavioral: Diabetes education']}, {'type': 'NO_INTERVENTION', 'label': '3', 'description': 'Control group- regular treatment without any intervention'}], 'interventions': [{'name': 'psychological intervention', 'type': 'BEHAVIORAL', 'description': 'Psychological intervention', 'armGroupLabels': ['1']}, {'name': 'Diabetes education', 'type': 'BEHAVIORAL', 'description': '5 sessions with diabetes nurse', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petah Tikva', 'country': 'Israel', 'facility': "Schneider Children's Medical Center", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'overallOfficials': [{'name': 'Joseph Meyerovitch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rabin Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}