Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 2:25 PM
Study NCT ID:
NCT04896593
Status:
COMPLETED
Last Update Posted:
2023-03-30
First Post:
2021-05-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mobile Technology for Reducing and Preventing Adolescent Suicide
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013406', 'term': 'Suicide, Attempted'}, {'id': 'D059020', 'term': 'Suicidal Ideation'}], 'ancestors': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.tolin@hhchealth.org', 'phone': '860-545-7685', 'title': 'David Tolin, Ph.D.', 'organization': 'Anxiety Disorders Center'}, 'certainAgreement': {'otherDetails': 'The principal investigator was designated by the sponsor to be the party responsible for conducting the trial and has the right to publish the results of the trial with approval from the sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From study enrollment through 16 weeks post-discharge assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Smartphone app teaching suicide prevention skills.\n\nSmartphone App: Smartphone app teaching suicide prevention skills.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 19, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increase in anger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increase in SIQ-Jr total score above threshold', 'notes': 'Increase in SIQ-Jr total score above reliable change threshold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased fatigue in swimming', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling more down', 'notes': 'Feeling more down due to increased swim and school demands', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight gain', 'notes': '10lb weight gain at the end of swim season', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Medication side effects', 'notes': 'Side effects after stopped taking psychiatric medications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased mania', 'notes': 'Increased mania, frequently leaving house against parental wishes, discontinued psychiatric medications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sexual assault', 'notes': 'Reported sexual assault to police and study IE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thoughts of self-harm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ER and Urgent Care visits for migraines and vomiting.', 'notes': 'Increased migraines and anxiety, vomiting due to migraines. Having hard time going to school and seeing friends. Went to the ER 3 times and Urgent Care 2 times, not admitted to hospital due to migraines/vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ER visit for dizziness and not eating or drinking', 'notes': 'Transferred from psychiatric inpatient to ER for dizziness and not eating or drinking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ER visit for vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased stress, DCF involvement', 'notes': 'Increased stress, patient escorted home after spending the night outside of the home. DCF involved afterwards.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ER visit due to allergic reaction', 'notes': 'Accidental ingestion of nuts (has severe nut allergy), used epi pen. Went to ER and given steroid and Pepcid before discharged. No hospitalization.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral respiratory infection', 'notes': 'Not COVID/strep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Passive suicidal ideation, feeling more down', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ER visit for suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inpatient hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'App Usability 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Smartphone app teaching suicide prevention skills.\n\nSmartphone App: Smartphone app teaching suicide prevention skills.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.948', 'spread': '10.046', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week post discharge', 'description': 'The System Usability Scale (SUS) contains 10 items assessing the usability of digital technology. Items are rated from 1 to 5 with higher numbers representing stronger agreement with usability statements. Scores can range from 0 to 100, with higher scores reflecting better outcomes, meaning increased usability of the technology. The mean and standard deviation for the SUS will be reported utilizing all available data.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'App Usability 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Smartphone app teaching suicide prevention skills.\n\nSmartphone App: Smartphone app teaching suicide prevention skills.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.875', 'spread': '9.060', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks post discharge', 'description': 'The System Usability Scale (SUS) contains 10 items assessing the usability of digital technology. Items are rated from 1 to 5 with higher numbers representing stronger agreement with usability statements. Scores can range from 0 to 100, with higher scores reflecting better outcomes, meaning increased usability of the technology. The mean and standard deviation for the SUS will be reported utilizing all available data.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'App Usability 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Smartphone app teaching suicide prevention skills.\n\nSmartphone App: Smartphone app teaching suicide prevention skills.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.500', 'spread': '9.171', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks post discharge', 'description': 'The System Usability Scale (SUS) contains 10 items assessing the usability of digital technology. Items are rated from 1 to 5 with higher numbers representing stronger agreement with usability statements. Scores can range from 0 to 100, with higher scores reflecting better outcomes, meaning increased usability of the technology. The mean and standard deviation for the SUS will be reported utilizing all available data.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'App Usability 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Smartphone app teaching suicide prevention skills.\n\nSmartphone App: Smartphone app teaching suicide prevention skills.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.833', 'spread': '10.457', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks post discharge', 'description': 'The System Usability Scale (SUS) contains 10 items assessing the usability of digital technology. Items are rated from 1 to 5 with higher numbers representing stronger agreement with usability statements. Scores can range from 0 to 100, with higher scores reflecting better outcomes, meaning increased usability of the technology. The mean and standard deviation for the SUS will be reported utilizing all available data.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'App Usability 16 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Smartphone app teaching suicide prevention skills.\n\nSmartphone App: Smartphone app teaching suicide prevention skills.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.625', 'spread': '8.827', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks post discharge', 'description': 'The System Usability Scale (SUS) contains 10 items assessing the usability of digital technology. Items are rated from 1 to 5 with higher numbers representing stronger agreement with usability statements. Scores can range from 0 to 100, with higher scores reflecting better outcomes, meaning increased usability of the technology. The mean and standard deviation for the SUS will be reported utilizing all available data.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Suicidal Ideation Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Smartphone app teaching suicide prevention skills.\n\nSmartphone App: Smartphone app teaching suicide prevention skills.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.700', 'spread': '18.966', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The SIQ Jr is a 15-item measure assesses suicidal thoughts on a 7-point scale, with possible total scores ranging from 0-90). Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Suicidal Ideation 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Smartphone app teaching suicide prevention skills.\n\nSmartphone App: Smartphone app teaching suicide prevention skills.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.421', 'spread': '12.048', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Week post discharge', 'description': 'The SIQ Jr is a 15-item measure assesses suicidal thoughts on a 7-point scale, with possible total scores ranging from 0-90). Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Suicidal Ideation 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Smartphone app teaching suicide prevention skills.\n\nSmartphone App: Smartphone app teaching suicide prevention skills.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.125', 'spread': '15.165', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 Weeks post discharge', 'description': 'The SIQ Jr is a 15-item measure assesses suicidal thoughts on a 7-point scale, with possible total scores ranging from 0-90). Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Suicidal Ideation 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Smartphone app teaching suicide prevention skills.\n\nSmartphone App: Smartphone app teaching suicide prevention skills.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.200', 'spread': '18.033', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 Weeks post discharge', 'description': 'The SIQ Jr is a 15-item measure assesses suicidal thoughts on a 7-point scale, with possible total scores ranging from 0-90). Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Suicidal Ideation 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Smartphone app teaching suicide prevention skills.\n\nSmartphone App: Smartphone app teaching suicide prevention skills.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.867', 'spread': '19.375', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks post discharge', 'description': 'The SIQ Jr is a 15-item measure assesses suicidal thoughts on a 7-point scale, with possible total scores ranging from 0-90). Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Suicidal Ideation 16 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Smartphone app teaching suicide prevention skills.\n\nSmartphone App: Smartphone app teaching suicide prevention skills.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.625', 'spread': '16.045', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 Weeks post discharge', 'description': 'The SIQ Jr is a 15-item measure assesses suicidal thoughts on a 7-point scale, with possible total scores ranging from 0-90). Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Smartphone app teaching suicide prevention skills.\n\nSmartphone App: Smartphone app teaching suicide prevention skills.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Did not complete onboarding', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Smartphone app teaching suicide prevention skills.\n\nSmartphone App: Smartphone app teaching suicide prevention skills.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14.8182', 'spread': '1.2587', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Gender', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Trans male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Nonbinary/Genderfluid', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline SIQ', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '54.700', 'spread': '18.966', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '2 participants consented but dropped from the study prior to receiving the intervention (app). They were not included in the outcome analysis.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-04', 'size': 4188709, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-27T14:46', 'hasProtocol': True}, {'date': '2020-07-14', 'size': 183815, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-27T14:48', 'hasProtocol': False}, {'date': '2021-05-24', 'size': 611713, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-12-06T09:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-29', 'studyFirstSubmitDate': '2021-05-14', 'resultsFirstSubmitDate': '2023-01-20', 'studyFirstSubmitQcDate': '2021-05-20', 'lastUpdatePostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-29', 'studyFirstPostDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'App Usability 1 Week', 'timeFrame': '1 week post discharge', 'description': 'The System Usability Scale (SUS) contains 10 items assessing the usability of digital technology. Items are rated from 1 to 5 with higher numbers representing stronger agreement with usability statements. Scores can range from 0 to 100, with higher scores reflecting better outcomes, meaning increased usability of the technology. The mean and standard deviation for the SUS will be reported utilizing all available data.'}, {'measure': 'App Usability 4 Weeks', 'timeFrame': '4 weeks post discharge', 'description': 'The System Usability Scale (SUS) contains 10 items assessing the usability of digital technology. Items are rated from 1 to 5 with higher numbers representing stronger agreement with usability statements. Scores can range from 0 to 100, with higher scores reflecting better outcomes, meaning increased usability of the technology. The mean and standard deviation for the SUS will be reported utilizing all available data.'}, {'measure': 'App Usability 8 Weeks', 'timeFrame': '8 weeks post discharge', 'description': 'The System Usability Scale (SUS) contains 10 items assessing the usability of digital technology. Items are rated from 1 to 5 with higher numbers representing stronger agreement with usability statements. Scores can range from 0 to 100, with higher scores reflecting better outcomes, meaning increased usability of the technology. The mean and standard deviation for the SUS will be reported utilizing all available data.'}, {'measure': 'App Usability 12 Weeks', 'timeFrame': '12 weeks post discharge', 'description': 'The System Usability Scale (SUS) contains 10 items assessing the usability of digital technology. Items are rated from 1 to 5 with higher numbers representing stronger agreement with usability statements. Scores can range from 0 to 100, with higher scores reflecting better outcomes, meaning increased usability of the technology. The mean and standard deviation for the SUS will be reported utilizing all available data.'}, {'measure': 'App Usability 16 Weeks', 'timeFrame': '16 weeks post discharge', 'description': 'The System Usability Scale (SUS) contains 10 items assessing the usability of digital technology. Items are rated from 1 to 5 with higher numbers representing stronger agreement with usability statements. Scores can range from 0 to 100, with higher scores reflecting better outcomes, meaning increased usability of the technology. The mean and standard deviation for the SUS will be reported utilizing all available data.'}], 'secondaryOutcomes': [{'measure': 'Suicidal Ideation Baseline', 'timeFrame': 'Baseline', 'description': 'The SIQ Jr is a 15-item measure assesses suicidal thoughts on a 7-point scale, with possible total scores ranging from 0-90). Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data.'}, {'measure': 'Suicidal Ideation 1 Week', 'timeFrame': '1 Week post discharge', 'description': 'The SIQ Jr is a 15-item measure assesses suicidal thoughts on a 7-point scale, with possible total scores ranging from 0-90). Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data.'}, {'measure': 'Suicidal Ideation 4 Weeks', 'timeFrame': '4 Weeks post discharge', 'description': 'The SIQ Jr is a 15-item measure assesses suicidal thoughts on a 7-point scale, with possible total scores ranging from 0-90). Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data.'}, {'measure': 'Suicidal Ideation 8 Weeks', 'timeFrame': '8 Weeks post discharge', 'description': 'The SIQ Jr is a 15-item measure assesses suicidal thoughts on a 7-point scale, with possible total scores ranging from 0-90). Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data.'}, {'measure': 'Suicidal Ideation 12 Weeks', 'timeFrame': '12 Weeks post discharge', 'description': 'The SIQ Jr is a 15-item measure assesses suicidal thoughts on a 7-point scale, with possible total scores ranging from 0-90). Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data.'}, {'measure': 'Suicidal Ideation 16 Weeks', 'timeFrame': '16 Weeks post discharge', 'description': 'The SIQ Jr is a 15-item measure assesses suicidal thoughts on a 7-point scale, with possible total scores ranging from 0-90). Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Suicide, Attempted', 'Suicidal Ideation']}, 'descriptionModule': {'briefSummary': 'This single-group open-label trial will evaluate the feasibility and preliminary efficacy of a suicide prevention mobile application when used as an adjunct to usual care in adolescents.', 'detailedDescription': 'This study will enroll 20 adolescent (age 13-17) inpatients at elevated risk for suicide. Participants will download the app onto their phones during their inpatient stay and will complete a single therapy session involving psychoeducation and crisis response planning. Participants will be encouraged to use the app on their own in addition to their usual outpatient services to learn and practice suicide prevention skills. Participants and their parents will be interviewed 1, 4, 8, 12, and 16 weeks after discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Inpatient psychiatric patients who have attempted suicide (lifetime) or have documented suicide ideation and a plan to harm themselves at admission\n* Understand written and spoken English\n* Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher\n* Willing and able to complete enrollment procedures\n* Parent/guardian (and youth) able to understand the nature of the study and provide written informed consent (assent for youth)\n* Willing to agree to release of information to their parent/guardian and providers when clinically indicated.\n* Discharge plan includes aftercare within the Hartford HealthCare system (to facilitate coordination of care during follow up)\n\nExclusion Criteria:\n\n* Patients with active psychosis\n* Patients experiencing substance withdrawal\n* Currently enrolled in other treatment studies for the symptoms and behaviors targeted\n* Patient unwilling or unable to wear mask during in-person study procedures\n* Patients who, in the judgment of the investigator, would have an unfavorable risk/benefit profile with respect to the Smartphone App.\n* Any other psychiatric or medical condition (e.g., intellectual disability) or custody arrangement that in the investigator's opinion would preclude informed consent/assent or participation in the trial."}, 'identificationModule': {'nctId': 'NCT04896593', 'briefTitle': 'Mobile Technology for Reducing and Preventing Adolescent Suicide', 'organization': {'class': 'OTHER', 'fullName': 'Hartford Hospital'}, 'officialTitle': 'Mobile Technology for Reducing and Preventing Adolescent Suicide', 'orgStudyIdInfo': {'id': 'HHC-2020-0363'}, 'secondaryIdInfos': [{'id': 'R43MH125691', 'link': 'https://reporter.nih.gov/quickSearch/R43MH125691', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Smartphone app teaching suicide prevention skills.', 'interventionNames': ['Behavioral: Smartphone App']}], 'interventions': [{'name': 'Smartphone App', 'type': 'BEHAVIORAL', 'description': 'Smartphone app teaching suicide prevention skills.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Institute of Living/Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'overallOfficials': [{'name': 'David Tolin, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Living/Hartford Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hartford Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oui Therapeutics, Inc.', 'class': 'INDUSTRY'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}