Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-02-20 @ 10:10 PM
Study NCT ID:
NCT03633903
Status:
COMPLETED
Last Update Posted:
2021-08-19
First Post:
2018-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mindfulness for Resilience in Early Life
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nkirlic@laureateinstitute.org', 'phone': '918-502-5747', 'title': 'Namik Kirlic, PhD', 'organization': 'Laureate Institute for Brain Research'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored throughout baseline (T1), 8 sessions of twice-weekly intervention where survey responses were recorded and the MBSR-T group had group intervention (T2-T9), and follow-up (T10).', 'description': 'No adverse events were reported or observed.', 'eventGroups': [{'id': 'EG000', 'title': 'Mindfulness', 'description': 'Mindfulness: Eight sessions, twice per week over four weeks\n\nMindfulness: Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Treatment as usual, inactive control group', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cortisol Reactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness', 'description': 'Mindfulness: Eight sessions, twice per week over four weeks\n\nMindfulness: Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience'}, {'id': 'OG001', 'title': 'Control', 'description': 'Treatment as usual, inactive control group'}], 'classes': [{'title': 'follow-up, pre stress induction', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'follow-up, post stress induction', 'categories': [{'measurements': [{'value': '0.05', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.04', 'pValueComment': 'The reported p-value was calculated and is not indicating a threshold for significance.\n\nThis applies to the change from row 1 to row 3 (e.g., baseline pre TSST-C versus follow-up timepoint pre TSST-C)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.77', 'pValueComment': 'The reported p-value was calculated and is not indicating a threshold for significance.\n\nThis is for the difference from row 1 to row 2 (baseline pre versus baseline post TSST-C)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.40', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.38', 'pValueComment': 'The reported p-value was calculated and is not indicating a threshold for significance.\n\nComparing row 1 and row 4 (baseline pre TSST-C versus follow-up post TSST-C).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline', 'description': 'Change in level of cortisol in saliva following a social stress test. Subjects completed the Trier Social Stress Test for Children (TSST-C) at baseline and follow-up. The TSST-C consists of public speaking and serial subtraction components in front of two research confederates. The test takes approximately 20 minutes to complete. Salivary cortisol was collected 20 minutes prior to TSST-C, and 20 minutes following the end of the TSST-C, such that the TSST-C task with data collection spanned approximately one hour.', 'unitOfMeasure': 'μg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two subjects were removed from all analyses due to not having usable baseline data and withdrawing prior to intervention. One was removed from each group, such than N=22-1=21 analyzed for mindfulness and N=18-1=17 for control.'}, {'type': 'PRIMARY', 'title': 'Immune System Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness', 'description': 'Mindfulness: Eight sessions, twice per week over four weeks\n\nMindfulness: Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience'}, {'id': 'OG001', 'title': 'Control', 'description': 'Treatment as usual, inactive control group'}], 'classes': [{'title': 'CRP (followup)', 'categories': [{'measurements': [{'value': '0.83', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '1.32', 'groupId': 'OG001'}]}]}, {'title': "I'll-6 (followup)", 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '0.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.39', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.35', 'groupDescription': 'Comparing group differences (CRP biomarker) in mindfulness versus control at baseline versus follow-up timepoints.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.95', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.02', 'groupDescription': 'Comparing group differences (IL-6 biomarker) in mindfulness versus control at baseline versus follow-up timepoints.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline', 'description': 'Change in level of interleukin 6 (IL-6) and C-reactive protein (CRP) in blood', 'unitOfMeasure': 'pg/mL; mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two subjects were removed from all analyses due to not having usable baseline data and withdrawing prior to intervention. One was removed from each group, such than N=22-1=21 analyzed for mindfulness and N=18-1=17 for control.'}, {'type': 'SECONDARY', 'title': 'Mood and Feelings Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness', 'description': 'Mindfulness: Eight sessions, twice per week over four weeks\n\nMindfulness: Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience'}, {'id': 'OG001', 'title': 'Control', 'description': 'Treatment as usual, inactive control group'}], 'classes': [{'categories': [{'measurements': [{'value': '3.82', 'spread': '4.61', 'groupId': 'OG000'}, {'value': '8.17', 'spread': '8.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.08', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.13', 'pValueComment': 'the calculated p value.', 'groupDescription': 'Comparing group differences (symptoms of anxiety/depression) in mindfulness versus control at baseline versus follow-up timepoints.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline', 'description': 'Measure Description: We used the Mood and Feelings Questionnaire - Short Form (MFQ-sf) to characterize symptoms of anxiety and depression. The MFQ-sf is a 13-item questionnaire with a simple sum score for the entire scale. Minimum score = 0, maximum score = 26. Scores of 8 or more indicate moderate depression.\n\nCodings reflect whether the phrase was descriptive of the subject most of the time, sometimes, or not at all. Higher scores indicate greater symptoms of anxiety/depression, while lower scores indicate less anxiety/depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two subjects were removed from all analyses due to not having usable baseline data and withdrawing prior to intervention. One was removed from each group, such than N=22-1=21 analyzed for mindfulness and N=18-1=17 for control.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mindfulness', 'description': 'Mindfulness: Eight sessions, twice per week over four weeks\n\nMindfulness: Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience'}, {'id': 'FG001', 'title': 'Control', 'description': 'Treatment as usual, inactive control group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Intent to Treat', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Adolescents and their families were recruited from the community using flyers, radio advertisements, billboards, and a school-based messaging platform (e.g., PeachJar).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mindfulness', 'description': 'Mindfulness: Eight sessions, twice per week over four weeks\n\nMindfulness: Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience'}, {'id': 'BG001', 'title': 'Control', 'description': 'Treatment as usual, inactive control group'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14.33', 'spread': '0.73', 'groupId': 'BG000'}, {'value': '14.29', 'spread': '0.77', 'groupId': 'BG001'}, {'value': '14.31', 'spread': '0.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Two subjects were removed from analyses due to not beginning intervention or control group.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Two subjects were removed from analyses due to not beginning intervention or control group.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Two subjects were removed from analyses due to not beginning intervention or control group.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Two subjects were removed from analyses due to not beginning intervention or control group.'}, {'title': 'Change in salivary cortisol', 'classes': [{'title': 'baseline, pre stress induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.89', 'groupId': 'BG000'}, {'value': '-0.16', 'spread': '1.15', 'groupId': 'BG001'}, {'value': '-0.02', 'spread': '1.02', 'groupId': 'BG002'}]}]}, {'title': 'baseline, post stress induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.88', 'groupId': 'BG000'}, {'value': '0.27', 'spread': '1.10', 'groupId': 'BG001'}, {'value': '0.025', 'spread': '0.99', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This measure is the change in cortisol from the stress induction task. Salivary cortisol was collected 20 minutes before and 20 minutes after stress induction. For analyses, we subtracted post minus pre cortisol levels, such that negative values are possible if post stress induction cortisol was lower than pre stress induction cortisol.', 'unitOfMeasure': 'μg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Two subjects were removed from analysis due to not beginning intervention or control.'}, {'title': 'C-reactive protein', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.16', 'spread': '3.82', 'groupId': 'BG000'}, {'value': '2.39', 'spread': '5.75', 'groupId': 'BG001'}, {'value': '1.775', 'spread': '4.785', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Two subjects were removed from analysis due to not beginning intervention or control.'}, {'title': 'Interleukin-6', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.48', 'groupId': 'BG000'}, {'value': '0.83', 'spread': '1.19', 'groupId': 'BG001'}, {'value': '0.65', 'spread': '0.835', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Two subjects were removed from analysis due to not beginning intervention or control.'}, {'title': 'Depression and Anxiety Symptoms', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.81', 'spread': '4.53', 'groupId': 'BG000'}, {'value': '9.39', 'spread': '6.54', 'groupId': 'BG001'}, {'value': '8.1', 'spread': '5.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'We used the Mood and Feelings Questionnaire - Short Form (MFQ-sf) to characterize symptoms of anxiety and depression. The MFQ-sf is a 13-item questionnaire with a simple sum score for the entire scale. Minimum score = 0, maximum score = 26. Scores of 8 or more indicate moderate depression.\n\nCodings reflect whether the phrase was descriptive of the subject most of the time, sometimes, or not at all. Higher scores indicate greater symptoms of anxiety/depression, while lower scores indicate less anxiety/depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Two subjects were removed from analysis due to not beginning intervention or control.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-31', 'size': 421142, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-30T16:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Adolescents are randomly assigned to either a mindfulness intervention or no intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-27', 'studyFirstSubmitDate': '2018-08-13', 'resultsFirstSubmitDate': '2021-06-08', 'studyFirstSubmitQcDate': '2018-08-14', 'lastUpdatePostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-27', 'studyFirstPostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cortisol Reactivity', 'timeFrame': 'Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline', 'description': 'Change in level of cortisol in saliva following a social stress test. Subjects completed the Trier Social Stress Test for Children (TSST-C) at baseline and follow-up. The TSST-C consists of public speaking and serial subtraction components in front of two research confederates. The test takes approximately 20 minutes to complete. Salivary cortisol was collected 20 minutes prior to TSST-C, and 20 minutes following the end of the TSST-C, such that the TSST-C task with data collection spanned approximately one hour.'}, {'measure': 'Immune System Activity', 'timeFrame': 'Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline', 'description': 'Change in level of interleukin 6 (IL-6) and C-reactive protein (CRP) in blood'}], 'secondaryOutcomes': [{'measure': 'Mood and Feelings Questionnaire', 'timeFrame': 'Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline', 'description': 'Measure Description: We used the Mood and Feelings Questionnaire - Short Form (MFQ-sf) to characterize symptoms of anxiety and depression. The MFQ-sf is a 13-item questionnaire with a simple sum score for the entire scale. Minimum score = 0, maximum score = 26. Scores of 8 or more indicate moderate depression.\n\nCodings reflect whether the phrase was descriptive of the subject most of the time, sometimes, or not at all. Higher scores indicate greater symptoms of anxiety/depression, while lower scores indicate less anxiety/depression.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early life stress', 'Adolescent', 'Mindfulness', 'Neurobiological', 'Stress', 'Resilience'], 'conditions': ['Adolescent With Early Life Stress', 'Resilience']}, 'referencesModule': {'references': [{'pmid': '33858395', 'type': 'DERIVED', 'citation': 'Cohen ZP, Cosgrove KT, Akeman E, Coffey S, Teague K, Hays-Grudo J, Paulus MP, Aupperle RL, Kirlic N. The effect of a mindfulness-based stress intervention on neurobiological and symptom measures in adolescents with early life stress: a randomized feasibility study. BMC Complement Med Ther. 2021 Apr 15;21(1):123. doi: 10.1186/s12906-021-03295-1.'}]}, 'descriptionModule': {'briefSummary': 'Early life stress (ELS) is associated with a number of psychiatric and medical conditions later in life, thought to be caused by subsequent disruptions in biological processes involved in regulation of stress responses. Given that these alterations have long-lasting effects, there is a great need for effective preventative interventions. The long-term goal of this project is to identify early interventions that may most powerfully mitigate risk for psychiatric illness among adolescents with exposure to early life stress (ELS), with a focus on interventions that can be widely and effectively implemented, have the potential for long-lasting benefits, and can effectively engage targeted neurobiological processes and networks. The specific aims of the present study are to 1) examine how ELS impacts biological processes associated with regulation of stress, and 2) identify how MBI impacts affective symptoms and biological processes dysregulated by ELS.\n\nThis study supports the efforts to reduce the effects of early adversity in children by testing an impact of an effective psychological intervention on disrupted biological processes caused by early adversity. Successful achievement of the proposed aims will contribute to a) the knowledge base needed to reduce the effects of trauma and stress in children and families and b) the development of easily implemented and disseminated preventative interventions.\n\nThe proposed study will utilize a multi-method design to examine the effect of mindfulness on biological processes (i.e., stress responses) disrupted by exposure to ELS among adolescents age 13 to 15. Adolescents will first complete self-report measures of childhood adverse experiences, trauma, and neglect. Forty eligible adolescents will be next randomly assigned to either an eight session mindfulness-based stress reduction intervention for teens or no treatment. Pre- and post-intervention assessment will include (a) self-report measures of symptoms and emotion regulation, (b) a blood draw for assessment of inflammatory markers and gene expression, and (c) a stress task with saliva cortisol collected before and after this task.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 13.00 to 15.99 years at time of baseline assessment\n* Able to validly and safely complete baseline assessments\n* All genders\n* All races\n* Eligibility as a subject with early life stress will be determined by:\n* Scoring 4 or greater on Adverse Childhood Experiences (ACE) scale, with at least two experiences having occurred prior to age 10.\n\nExclusion Criteria:\n\n* No biological parent or legal guardian identified to give permission for minor to participate\n* History of neurological disorders including seizure disorder, cerebral palsy, or other conditions requiring neurological or medical care, being managed for migraines (e.g., daily prophylactic medication, seeing a neurologist for migraines), or a diagnosis of Developmental Delay, including severe learning disorder, mental retardation, pervasive developmental disorder, or other conditions requiring repeated and persistent specialized education.\n* Current psychotic disorder, bipolar disorder, obsessive-compulsive and related disorders, substance use disorder, or conduct disorder.\n* Current active suicidal ideation.\n* Current use of medications with major effects on brain function or blood flow (e.g., antipsychotics, mood stabilizers); ADHD medications and SSRIs, that have been stable for at least 6 weeks, are not exclusionary since their use is associated with conditions that confer risk for monitored disorders that emerge in adolescence, and assessment of these individuals will provide useful data to the scientific community. Youth on ADHD medications and SSRIs will not be asked to go off their medications.\n* Not fluent in English\n* Non-correctable vision, hearing or sensorimotor impairments, as protocol elements may not be valid.\n* Youth planning to move to an area not within reasonable traveling distance of LIBR; knowledge at baseline that treatment completion / follow-up will not be possible.\n* Youth appears to be high/intoxicated, or withdrawing from the effects of alcohol or drugs at time of enrollment.\n* Youth / parent who are unable or unwilling to provide biological samples (i.e., blood draws or saliva collection).\n* Female youth who are pregnant\n* Youth who are currently in unsafe environments (e.g., currently living with an abusive parent)'}, 'identificationModule': {'nctId': 'NCT03633903', 'acronym': 'MindREaL', 'briefTitle': 'Mindfulness for Resilience in Early Life', 'organization': {'class': 'OTHER', 'fullName': 'Laureate Institute for Brain Research, Inc.'}, 'officialTitle': 'Mindfulness for Resilience in Early Life', 'orgStudyIdInfo': {'id': 'LIBR # 2018-003-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mindfulness', 'description': 'Mindfulness: Eight sessions, twice per week over four weeks. Surveys administered prior to each session.', 'interventionNames': ['Behavioral: Mindfulness']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Treatment as usual (i.e., pharmacotherapy, psychotherapy, etc.) for the four week duration with twice weekly surveys administered.'}], 'interventions': [{'name': 'Mindfulness', 'type': 'BEHAVIORAL', 'description': 'Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience', 'armGroupLabels': ['Mindfulness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Laureate Institute for Brain Research', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}], 'overallOfficials': [{'name': 'Namik Kirlic, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laureate Institute for Brain Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laureate Institute for Brain Research, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oklahoma State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}