Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 4:38 PM
Study NCT ID:
NCT02746627
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2016-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Check It! Positive Psychology Intervention to Improve Adherence in Adolescents With T1D
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sarah.jaser@vanderbilt.edu', 'phone': '615-343-6775', 'title': 'Sarah Jaser, PhD', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Education', 'description': 'Participants receive educational materials in the mail every 2 weeks for 8 weeks.\n\nEducation: Educational materials on diabetes management', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Positive Affect - Text', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.\n\nPositive Affect: Positive psychology intervention to improve motivation for diabetes management.\n\nEducation: Educational materials on diabetes management', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Positive Affect - Phone', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.\n\nPositive Affect: Positive psychology intervention to improve motivation for diabetes management.\n\nEducation: Educational materials on diabetes management', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Glycemic Control (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Education', 'description': 'Participants receive educational materials in the mail every 2 weeks for 8 weeks.\n\nEducation: Educational materials on diabetes management'}, {'id': 'OG001', 'title': 'Positive Affect - Text', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.\n\nPositive Affect: Positive psychology intervention to improve motivation for diabetes management.\n\nEducation: Educational materials on diabetes management'}, {'id': 'OG002', 'title': 'Positive Affect - Phone', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.\n\nPositive Affect: Positive psychology intervention to improve motivation for diabetes management.\n\nEducation: Educational materials on diabetes management'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '9.7'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '9.8'}, {'value': '8.5', 'groupId': 'OG002', 'lowerLimit': '8', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'HbA1c measured as part of diabetes clinic visit. The target for children and adolescents is \\<7.5%.', 'unitOfMeasure': 'percentage of glycated hemoglobin', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Frequency of Blood Glucose Monitoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Education', 'description': 'Participants receive educational materials in the mail every 2 weeks for 8 weeks.\n\nEducation: Educational materials on diabetes management'}, {'id': 'OG001', 'title': 'Positive Affect - Text', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.\n\nPositive Affect: Positive psychology intervention to improve motivation for diabetes management.\n\nEducation: Educational materials on diabetes management'}, {'id': 'OG002', 'title': 'Positive Affect - Phone', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.\n\nPositive Affect: Positive psychology intervention to improve motivation for diabetes management.\n\nEducation: Educational materials on diabetes management'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '3.7'}, {'value': '3.46', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '4'}, {'value': '2.8', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '3.51'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Glucometer download to determine blood glucose checks per day.', 'unitOfMeasure': 'blood glucose checks per day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diabetes-Related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Education', 'description': 'Participants receive educational materials in the mail every 2 weeks for 8 weeks.\n\nEducation: Educational materials on diabetes management'}, {'id': 'OG001', 'title': 'Positive Affect - Text', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.\n\nPositive Affect: Positive psychology intervention to improve motivation for diabetes management.\n\nEducation: Educational materials on diabetes management'}, {'id': 'OG002', 'title': 'Positive Affect - Phone', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.\n\nPositive Affect: Positive psychology intervention to improve motivation for diabetes management.\n\nEducation: Educational materials on diabetes management'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '62.5', 'upperLimit': '82'}, {'value': '79', 'groupId': 'OG001', 'lowerLimit': '72', 'upperLimit': '82'}, {'value': '73', 'groupId': 'OG002', 'lowerLimit': '68', 'upperLimit': '83'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': "The Pediatric Quality of Life (PedsQL) Diabetes-Specific Module assesses adolescents' self-reported quality of life. Scaled scores range from 0-100, with higher scores indicating better quality of life.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Family Conflict', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Education', 'description': 'Participants receive educational materials in the mail every 2 weeks for 8 weeks.\n\nEducation: Educational materials on diabetes management'}, {'id': 'OG001', 'title': 'Positive Affect - Text', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.\n\nPositive Affect: Positive psychology intervention to improve motivation for diabetes management.\n\nEducation: Educational materials on diabetes management'}, {'id': 'OG002', 'title': 'Positive Affect - Phone', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.\n\nPositive Affect: Positive psychology intervention to improve motivation for diabetes management.\n\nEducation: Educational materials on diabetes management'}], 'classes': [{'title': 'Child reported', 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '36'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '44'}, {'value': '36', 'groupId': 'OG002', 'lowerLimit': '21', 'upperLimit': '45'}]}]}, {'title': 'Parent reported', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '35'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '29'}, {'value': '25', 'groupId': 'OG002', 'lowerLimit': '21', 'upperLimit': '28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale, which consists of 19 items regarding how much adolescents and parents argue about diabetes management tasks. Scores range from 19-57, and higher scores indicate greater conflict.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Positive Affect', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Education', 'description': 'Participants receive educational materials in the mail every 2 weeks for 8 weeks.\n\nEducation: Educational materials on diabetes management'}, {'id': 'OG001', 'title': 'Positive Affect - Text', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.\n\nPositive Affect: Positive psychology intervention to improve motivation for diabetes management.\n\nEducation: Educational materials on diabetes management'}, {'id': 'OG002', 'title': 'Positive Affect - Phone', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.\n\nPositive Affect: Positive psychology intervention to improve motivation for diabetes management.\n\nEducation: Educational materials on diabetes management'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '27.5', 'upperLimit': '42.5'}, {'value': '37', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '42'}, {'value': '41', 'groupId': 'OG002', 'lowerLimit': '32', 'upperLimit': '46'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Positive affect measured using the Positive and Negative Affect Scale for children (PANAS-C). The positive affect scale consists of 15 items. Scores range from 15-75, and higher scores indicate higher levels of positive affect.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Coping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Education', 'description': 'Participants receive educational materials in the mail every 2 weeks for 8 weeks.\n\nEducation: Educational materials on diabetes management'}, {'id': 'OG001', 'title': 'Positive Affect - Text', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.\n\nPositive Affect: Positive psychology intervention to improve motivation for diabetes management.\n\nEducation: Educational materials on diabetes management'}, {'id': 'OG002', 'title': 'Positive Affect - Phone', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.\n\nPositive Affect: Positive psychology intervention to improve motivation for diabetes management.\n\nEducation: Educational materials on diabetes management'}], 'classes': [{'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '125'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '87', 'upperLimit': '126'}, {'value': '104', 'groupId': 'OG002', 'lowerLimit': '92', 'upperLimit': '121'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Responses to Stress Questionnaire measures coping strategies used in response to diabetes-related stress. Scores range from 57-228, and higher scores indicate more responses to stress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Education', 'description': 'Participants receive educational materials in the mail every 2 weeks for 8 weeks.\n\nEducation: Educational materials on diabetes management'}, {'id': 'FG001', 'title': 'Positive Affect - Text', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.\n\nPositive Affect: Positive psychology intervention to improve motivation for diabetes management.\n\nEducation: Educational materials on diabetes management'}, {'id': 'FG002', 'title': 'Positive Affect - Phone', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.\n\nPositive Affect: Positive psychology intervention to improve motivation for diabetes management.\n\nEducation: Educational materials on diabetes management'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Education', 'description': 'Participants receive educational materials in the mail every 2 weeks for 8 weeks.\n\nEducation: Educational materials on diabetes management'}, {'id': 'BG001', 'title': 'Positive Affect - Text', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.\n\nPositive Affect: Positive psychology intervention to improve motivation for diabetes management.\n\nEducation: Educational materials on diabetes management'}, {'id': 'BG002', 'title': 'Positive Affect - Phone', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.\n\nPositive Affect: Positive psychology intervention to improve motivation for diabetes management.\n\nEducation: Educational materials on diabetes management'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.92', 'spread': '1.42', 'groupId': 'BG000'}, {'value': '14.62', 'spread': '1.63', 'groupId': 'BG001'}, {'value': '14.97', 'spread': '1.40', 'groupId': 'BG002'}, {'value': '14.86', 'spread': '1.46', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White-Non Hispanic', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}]}]}, {'title': 'Black or African american', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Biracial/Multiracial', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'White Hispanic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were assigned to Positive Affect - Phone, Positive Affect - Text, or Education groups for the duration of the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-20', 'studyFirstSubmitDate': '2016-04-05', 'resultsFirstSubmitDate': '2018-01-04', 'studyFirstSubmitQcDate': '2016-04-20', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-18', 'studyFirstPostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic Control (HbA1c)', 'timeFrame': '6 months', 'description': 'HbA1c measured as part of diabetes clinic visit. The target for children and adolescents is \\<7.5%.'}], 'secondaryOutcomes': [{'measure': 'Frequency of Blood Glucose Monitoring', 'timeFrame': '6 months', 'description': 'Glucometer download to determine blood glucose checks per day.'}, {'measure': 'Diabetes-Related Quality of Life', 'timeFrame': '6 months', 'description': "The Pediatric Quality of Life (PedsQL) Diabetes-Specific Module assesses adolescents' self-reported quality of life. Scaled scores range from 0-100, with higher scores indicating better quality of life."}, {'measure': 'Family Conflict', 'timeFrame': '6 months', 'description': 'Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale, which consists of 19 items regarding how much adolescents and parents argue about diabetes management tasks. Scores range from 19-57, and higher scores indicate greater conflict.'}, {'measure': 'Positive Affect', 'timeFrame': '6 months', 'description': 'Positive affect measured using the Positive and Negative Affect Scale for children (PANAS-C). The positive affect scale consists of 15 items. Scores range from 15-75, and higher scores indicate higher levels of positive affect.'}, {'measure': 'Coping', 'timeFrame': '6 months', 'description': 'Responses to Stress Questionnaire measures coping strategies used in response to diabetes-related stress. Scores range from 57-228, and higher scores indicate more responses to stress.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '29543490', 'type': 'DERIVED', 'citation': 'Savin KL, Hamburger ER, Monzon AD, Patel NJ, Perez KM, Lord JH, Jaser SS. Diabetes-specific family conflict: Informant discrepancies and the impact of parental factors. J Fam Psychol. 2018 Feb;32(1):157-163. doi: 10.1037/fam0000364.'}]}, 'descriptionModule': {'briefSummary': "Problems with diabetes management in adolescents with type 1 diabetes are common - occurring at rates as high as 93% - and have serious health consequences, including poor blood sugar control and risk for later complications. Therefore, the investigators proposed to test a positive psychology intervention for adolescents with type 1 diabetes aimed at increasing motivation for diabetes management; specifically, to increase the frequency of blood glucose monitoring. This intervention will boost positive mood in adolescents (age 13-17) through tailored exercises in gratitude, self-affirmation, small gifts, and parent affirmation as a way to improve motivation for diabetes management. In addition, this study will explore the use of technology, by comparing telephone-administered vs. automated text-messaging versions of the intervention, to determine which mode of delivery is more appealing, convenient, and beneficial for adolescents in managing their diabetes.\n\nParticipants and parents will complete questionnaires on mood and diabetes management during a routine clinic visits at baseline, 3 months, and 6 months. Clinical measures of diabetes management will be collected from participants' electronic medical records."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with type 1 diabetes for at least 6 months\n* HbA1c between 8-12%\n* Speak and read English\n* Caregiver living with child\n\nExclusion Criteria:\n\n* Other uncontrolled health conditions'}, 'identificationModule': {'nctId': 'NCT02746627', 'briefTitle': 'Check It! Positive Psychology Intervention to Improve Adherence in Adolescents With T1D', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Positive Psychology to Improve Adherence in Adolescents With Type 1 Diabetes', 'orgStudyIdInfo': {'id': '131384'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Education', 'description': 'Participants receive educational materials in the mail every 2 weeks for 8 weeks.', 'interventionNames': ['Behavioral: Education']}, {'type': 'EXPERIMENTAL', 'label': 'Positive Affect - Text', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.', 'interventionNames': ['Behavioral: Positive Affect', 'Behavioral: Education']}, {'type': 'EXPERIMENTAL', 'label': 'Positive Affect - Phone', 'description': 'Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.', 'interventionNames': ['Behavioral: Positive Affect', 'Behavioral: Education']}], 'interventions': [{'name': 'Positive Affect', 'type': 'BEHAVIORAL', 'description': 'Positive psychology intervention to improve motivation for diabetes management.', 'armGroupLabels': ['Positive Affect - Phone', 'Positive Affect - Text']}, {'name': 'Education', 'type': 'BEHAVIORAL', 'description': 'Educational materials on diabetes management', 'armGroupLabels': ['Education', 'Positive Affect - Phone', 'Positive Affect - Text']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sarah Jaser', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}