Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 617}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-01', 'studyFirstSubmitDate': '2020-09-21', 'studyFirstSubmitQcDate': '2020-09-21', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in safety behaviors measured by the Safety Behavior Checklist', 'timeFrame': 'Baseline, 3-, 6-, 12-months', 'description': 'Percent of safety behaviors that a person has tried that they found helpful measured on checklist adapted from Intimate Partner Violence Strategies Index to assess for the range of formal and informal help seeking strategies used to halt, escape, or resist violence, and the helpfulness of each strategy.'}, {'measure': 'Change from baseline in State of Change in Enacting Safety Behaviors', 'timeFrame': 'Baseline, 3-, 6-, 12-months', 'description': 'Score on a 0 - 5 scale indicating stage a person is in with regard to taking action to make their relationship healthy with 0 indicating no action and 5 indicating full action.'}], 'secondaryOutcomes': [{'measure': "Change from baseline in survivors' dating abuse experience measured by Conflict in Adolescent Dating Relationships Inventory (CADRI)", 'timeFrame': 'Baseline, 3-, 6-, 12-months', 'description': 'CADRI is an 11 item scale with a 5 point response scale (never to always) that measures the frequency of experiencing different forms of dating abuse'}, {'measure': "Change from baseline in survivors' depression measured by Pediatric Depressive Symptoms - Short Form 8a.", 'timeFrame': 'Baseline, 3-, 6-, 12-months', 'description': 'The Pediatric Depressive Symptoms - SF 8a is an 8 items scale with a 5 point response scale (never to always) that measures the frequency of different depressive symptoms. It was developed as part of the Patient-Reported Outcomes Measurement Information System (PROMIS).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intimate Partner Violence', 'Dating Violence', 'Relationships', 'Safety Planning', 'Adolescent', 'Technology', 'App', 'Teen'], 'conditions': ['Intimate Partner Violence']}, 'descriptionModule': {'briefSummary': "Intimate partner violence (IPV), including violence in teen dating relationships \\[teen dating violence (TDV)\\], is a common and a serious threat to adolescent health, safety, and well-being. TDV may include psychological/emotional abuse, sexual harassment or coercion, stalking (including cyberstalking), and physical or sexual violence. For many, the first experience of violence is in a dating or casual relationship with a partner or acquaintance during adolescence. Therefore, the objective of this study is to examine the effectiveness of an adapted version of the myPlan app for adolescents (ages 15-17 years) to prevent and respond to TDV. myPlan is an app available for mobile download or by web browser that interactively assists users to assess the health and safety of user's intimate relationship, receive personalized strategies on how build healthier relationships, stay safe and healthy while navigating an unsafe relationship, and get connected to support and resources."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 15-17 years old\n* Lives in the United States\n* Reports current or past 6 months physical violence, sexual violence, emotional abuse, verbal abuse, or staking (including cyberstalking or electronic aggression) by a dating/casual/intimate/ex-intimate partner\n* Speaks/reads English\n* Has access to a safe device (e.g., smartphone, tablet, or computer) with internet access and comfortable downloading an app or using the internet\n* Has a safe contact phone number or email address\n\nExclusion Criteria:\n\n* Younger than 15 years of age\n* Older than 17 years of age\n* Does not report current or past 6 months abuse from a dating/casual/intimate/ex- intimate partner\n* Does not speak/read English\n* Does not have access to a safe device (e.g., smartphone, tablet, or computer) with internet access\n* Does not have a safe contact phone number or email address'}, 'identificationModule': {'nctId': 'NCT04564261', 'briefTitle': 'Examining the Effectiveness of the myPlan App to Prevent Dating Violence With Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Examining the Effectiveness of the myPlan App to Prevent Dating Violence With Adolescents', 'orgStudyIdInfo': {'id': 'IRB00241935'}, 'secondaryIdInfos': [{'id': 'R01CE002979', 'link': 'https://reporter.nih.gov/quickSearch/R01CE002979', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'myPlan Teen Group', 'description': 'Personalized Healthy Relationship and Safety Planning Tool.', 'interventionNames': ['Behavioral: Personalized Healthy Relationship and Safety Planning Tool']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care Teen Control Group', 'description': 'Usual Care Teen Relationships and Health Resource.', 'interventionNames': ['Behavioral: Usual Care Teen Relationship and Health Website']}], 'interventions': [{'name': 'Personalized Healthy Relationship and Safety Planning Tool', 'type': 'BEHAVIORAL', 'otherNames': ['myPlan Teen'], 'description': 'The app delivers evidence-based information and resources in three sections:\n\nMy Relationship: contains a series of activities (e.g., "quizzes") to raise awareness of common myths about unhealthy relationships, determine characteristics of healthy relationships, examine the red flags in an unhealthy relationship, and assess risk factors for more severe abuse. Participants are provided with personalized messages about their relationship health and safety based on the answers they endorse.\n\nMy Strategies: personalized strategies to increase participants\' safety and well-being based on responses in the previous section.\n\nMy Resources: direct links to the National Dating Abuse hotline, textline, and chatline, as well as personalized health and safety resources.', 'armGroupLabels': ['myPlan Teen Group']}, {'name': 'Usual Care Teen Relationship and Health Website', 'type': 'BEHAVIORAL', 'description': 'The control group website will provide participants with tools to learn about health topics including examining healthy relationships. The resources will be targeted to adolescents. The control group website is not personalized to the participant or their relationship.', 'armGroupLabels': ['Usual Care Teen Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Nursing', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '65233', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Nancy E Glass, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}