Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT05194202
Status:
COMPLETED
Last Update Posted:
2024-11-06
First Post:
2021-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Emergency Department Healthcare Education Assessment and Response for Teen Relationships: A Pilot Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000294', 'term': 'Adolescent Behavior'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'karandell@cmh.edu', 'phone': '816-302-3503', 'title': 'Dr. Kimberly Randell', 'organization': "Children's Mercy Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'Definitions do not differ from clinicaltrials.gov definitions.', 'eventGroups': [{'id': 'EG000', 'title': 'ED-HEART (Intervention Arm)', 'description': 'All adolescents take a baseline survey in the Emergency Department (ED), receive Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED HEART) by a trained health educator, complete an exit survey while in the ED, complete a 6-week check-in to confirm contact information and aid retention, and complete a 12-week follow up survey.\n\nED-HEART: Behavioral intervention that addresses 1) healthy and unhealthy relationship behaviors, 2) conversation with partners around boundaries within relationships, 3) harm reduction strategies, and 4) resources for Adolescent Relationship Abuse (ARA) and related concerns, including Point of Care (POC) Reproductive and Sexual Health (RSH) harm reduction resources.', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 0, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Enhanced Standard Care (Control Arm)', 'description': 'All adolescents take a baseline survey in the Emergency Department (ED), receive enhanced standard care (i.e., standard care + teen resource list), complete a 6-week check in to confirm contact information and aid retention, and complete a 12-week follow up survey.', 'otherNumAtRisk': 87, 'deathsNumAtRisk': 87, 'otherNumAffected': 0, 'seriousNumAtRisk': 87, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participant Acceptability Ratings for Healthcare Provider Discussions on Relationships in ED-Heart Intervention Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ED-HEART (Intervention Arm)', 'description': 'All adolescents take a baseline survey in the Emergency Department (ED), receive Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED HEART) by a trained health educator, complete an exit survey while in the ED, complete a 6-week check-in to confirm contact information and aid retention, and complete a 12-week follow up survey.\n\nED-HEART: Behavioral intervention that assesses 1) healthy and unhealthy relationship behaviors, 2) conversation with partners around boundaries within relationships, 3) harm reduction strategies, and 4) resources for Adolescent Relationship Abuse (ARA) and related concerns, including Point of Care (POC) Reproductive and Sexual Health (RSH) harm reduction resources.'}], 'classes': [{'categories': [{'title': 'Strongly agree/agree', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}, {'title': 'Strongly disagree/disagree/neutral', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.622', 'groupIds': ['OG000'], 'groupDescription': 'Our null hypothesis for the acceptability was P0 great than or equal to 85% vs. the alternative P0 less than 85%. Acceptability responses were dichotomized to include neutral with strongly disagree/disagree.', 'statisticalMethod': 'one-sample test of proportions', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Hypothesis was evaluated using a one-tailed, one-proportion z-test.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': '1 survey item (investigator-developed) on acceptability of healthcare providers discussing healthy/unhealthy relationships, rated using 5-point Likert scale (strongly disagree/1 to strongly agree/5)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intervention participants answering acceptability item 1 on follow up survey'}, {'type': 'PRIMARY', 'title': 'Participant Acceptability Ratings for ED-based Relationship Intervention in ED-Heart Intervention Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ED-HEART (Intervention Arm)', 'description': 'All adolescents take a baseline survey in the Emergency Department (ED), receive Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED HEART) by a trained health educator, complete an exit survey while in the ED, complete a 6-week check-in to confirm contact information and aid retention, and complete a 12-week follow up survey.\n\nED-HEART: Behavioral intervention that assesses 1) healthy and unhealthy relationship behaviors, 2) conversation with partners around boundaries within relationships, 3) harm reduction strategies, and 4) resources for Adolescent Relationship Abuse (ARA) and related concerns, including Point of Care (POC) Reproductive and Sexual Health (RSH) harm reduction resources.'}], 'classes': [{'categories': [{'title': 'Strongly agree/agree', 'measurements': [{'value': '34', 'groupId': 'OG000'}]}, {'title': 'Strongly disagree/disagree/neutral', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.038', 'groupIds': ['OG000'], 'groupDescription': 'Our null hypothesis for the acceptabnility of the ED-Heart was P0 great than or equal to 85% vs. the alternative P0 less than 85%. Acceptability responses were dichotomized to include neutral with strongly disagree/disagree.', 'statisticalMethod': 'one sample test of proportions', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Hypothesis was evaluated using a one-tailed, one-proportion z-test'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': '1 survey item (investigator-developed) on acceptability of emergency department based healthy/unhealthy relationships intervention, rated using 5-point Likert scale (strongly disagree/1 to strongly agree/5)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intervention participants answering follow up survey acceptability of ED-based adolescent relationship intervention'}, {'type': 'SECONDARY', 'title': 'ARA Victimization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ED-HEART (Intervention Arm)', 'description': 'All adolescents take a baseline survey in the Emergency Department (ED), receive Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED HEART) by a trained health educator, complete an exit survey while in the ED, complete a 6-week check-in to confirm contact information and aid retention, and complete a 12-week follow up survey.\n\nED-HEART: Behavioral intervention that assesses 1) healthy and unhealthy relationship behaviors, 2) conversation with partners around boundaries within relationships, 3) harm reduction strategies, and 4) resources for Adolescent Relationship Abuse (ARA) and related concerns, including Point of Care (POC) Reproductive and Sexual Health (RSH) harm reduction resources.'}, {'id': 'OG001', 'title': 'Enhanced Standard Care (Control Arm)', 'description': 'All adolescents take a baseline survey in the Emergency Department (ED), receive enhanced standard care (i.e., standard care + teen resource list), complete a 6-week check in to confirm contact information and aid retention, and complete a 12-week follow up survey.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Report of ARA victimization will be considered positive for any positive answer to one or more of six survey items assessing physical ARA, sexual ARA, sexual exploitation within a dating relationship, and (among females) reproductive coercion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intervention and control arm participants who completed follow up surveys'}, {'type': 'SECONDARY', 'title': 'Recognition of Abusive Behaviors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ED-HEART (Intervention Arm)', 'description': 'All adolescents take a baseline survey in the Emergency Department (ED), receive Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED HEART) by a trained health educator, complete an exit survey while in the ED, complete a 6-week check-in to confirm contact information and aid retention, and complete a 12-week follow up survey.\n\nED-HEART: Behavioral intervention that addresses 1) healthy and unhealthy relationship behaviors, 2) conversation with partners around boundaries within relationships, 3) harm reduction strategies, and 4) resources for Adolescent Relationship Abuse (ARA) and related concerns, including Point of Care (POC) Reproductive and Sexual Health (RSH) harm reduction resources.'}, {'id': 'OG001', 'title': 'Enhanced Standard Care (Control Arm)', 'description': 'All adolescents take a baseline survey in the Emergency Department (ED), receive enhanced standard care (i.e., standard care + teen resource list), complete a 6-week check in to confirm contact information and aid retention, and complete a 12-week follow up survey.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.18', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '4.26', 'spread': '0.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': '19 survey items, adapted from the Recognition of ARA Scale. Each item answered with 5-point Likert scale that categorizes each behavior from not abusive (1) to extremely abusive (5). Scored as mean; higher score indicates increased recognition of behaviors as abusive.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intervention and control arm participants who completed follow up surveys'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ED-HEART (Intervention Arm)', 'description': 'All adolescents take a baseline survey in the Emergency Department (ED), receive Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED HEART) by a trained health educator, complete an exit survey while in the ED, complete a 6-week check-in to confirm contact information and aid retention, and complete a 12-week follow up survey.\n\nED-HEART: Behavioral intervention that addresses 1) healthy and unhealthy relationship behaviors, 2) conversation with partners around boundaries within relationships, 3) harm reduction strategies, and 4) resources for Adolescent Relationship Abuse (ARA) and related concerns, including Point of Care (POC) Reproductive and Sexual Health (RSH) harm reduction resources.'}, {'id': 'FG001', 'title': 'Enhanced Standard Care (Control Arm)', 'description': 'All adolescents take a baseline survey in the Emergency Department (ED), receive enhanced standard care (i.e., standard care + teen resource list), complete a 6-week check in to confirm contact information and aid retention, and complete a 12-week follow up survey.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '48'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ED-HEART (Intervention Arm)', 'description': 'All adolescents take a baseline survey in the Emergency Department (ED), receive Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED HEART) by a trained health educator, complete an exit survey while in the ED, complete a 6-week check-in to confirm contact information and aid retention, and complete a 12-week follow up survey.\n\nED-HEART: Behavioral intervention that addresses 1) healthy and unhealthy relationship behaviors, 2) conversation with partners around boundaries within relationships, 3) harm reduction strategies, and 4) resources for Adolescent Relationship Abuse (ARA) and related concerns, including Point of Care (POC) Reproductive and Sexual Health (RSH) harm reduction resources.'}, {'id': 'BG001', 'title': 'Enhanced Standard Care (Control Arm)', 'description': 'All adolescents take a baseline survey in the Emergency Department (ED), receive enhanced standard care (i.e., standard care + teen resource list), complete a 6-week check in to confirm contact information and aid retention, and complete a 12-week follow up survey.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.1', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '15.7', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '15.9', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '122', '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'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Commercial Insurance', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of adolescent relationship abuse', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Report of ARA victimization will be considered positive for any positive answer to one or more of six survey items assessing physical ARA, sexual ARA, sexual exploitation within a dating relationship, and (among females) reproductive coercion.', 'unitOfMeasure': 'Participants'}, {'title': 'History of dating', 'classes': [{'categories': [{'title': 'History of dating', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}, {'title': 'No history of dating', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-06-21', 'size': 754779, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-22T11:13', 'hasProtocol': True}, {'date': '2024-08-22', 'size': 443364, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-22T11:13', 'hasProtocol': False}, {'date': '2022-11-15', 'size': 481650, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-07-24T16:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Adolescents will be enrolled in one of two arms: Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) (intervention arm) or Enhanced Usual Care (control arm). Adolescents will complete study surveys at baseline (Baseline Survey; intervention and control arms), immediately post-intervention (Exit Survey, intervention arm), and 12 weeks after intervention delivery (Follow-up Survey, intervention and control arms).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-12', 'studyFirstSubmitDate': '2021-10-18', 'resultsFirstSubmitDate': '2024-08-22', 'studyFirstSubmitQcDate': '2022-01-06', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-12', 'studyFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant Acceptability Ratings for Healthcare Provider Discussions on Relationships in ED-Heart Intervention Arm', 'timeFrame': '12 weeks', 'description': '1 survey item (investigator-developed) on acceptability of healthcare providers discussing healthy/unhealthy relationships, rated using 5-point Likert scale (strongly disagree/1 to strongly agree/5)'}, {'measure': 'Participant Acceptability Ratings for ED-based Relationship Intervention in ED-Heart Intervention Arm', 'timeFrame': '12 weeks', 'description': '1 survey item (investigator-developed) on acceptability of emergency department based healthy/unhealthy relationships intervention, rated using 5-point Likert scale (strongly disagree/1 to strongly agree/5)'}], 'secondaryOutcomes': [{'measure': 'ARA Victimization', 'timeFrame': '12 weeks', 'description': 'Report of ARA victimization will be considered positive for any positive answer to one or more of six survey items assessing physical ARA, sexual ARA, sexual exploitation within a dating relationship, and (among females) reproductive coercion.'}, {'measure': 'Recognition of Abusive Behaviors', 'timeFrame': '12 weeks', 'description': '19 survey items, adapted from the Recognition of ARA Scale. Each item answered with 5-point Likert scale that categorizes each behavior from not abusive (1) to extremely abusive (5). Scored as mean; higher score indicates increased recognition of behaviors as abusive.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adolescent Behavior', 'Emergency Department', 'Abuse Physical', 'Abuse Mental', 'Abuse Verbal', 'Abuse Domestic', 'HEART', 'Intimate Partner Violence']}, 'descriptionModule': {'briefSummary': "This is a single-site, randomized, controlled trial. Investigators will evaluate feasibility of the Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) intervention among adolescents age 14-19 years receiving care in the Children's Mercy emergency department.", 'detailedDescription': 'This study is a mixed methods feasibility evaluation that will use a randomized controlled trial to assess feasibility of Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) (intervention arm: ED-HEART + teen resource list; control arm: enhanced standard care \\[standard care + teen resource list\\]). Adolescents age 14-19 years will be recruited and enrolled during an emergency department visit. Investigators will evaluate feasibility using the eight Bowen model feasibility constructs: acceptability, demand, implementation, practicality, adaptation, integration, expansion, and limited-efficacy testing. Investigators will also examine theory of planned behavior constructs (attitudes, beliefs, perceived behavioral control, intention) to facilitate exploratory analysis of factors that may contribute to differential outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* emergency department (ED) patient 14-19 years of age.\n\nExclusion Criteria:\n\n* Developmental delay, severe illness, or cognitive impairment precluding informed consent/assent or completion of study activities, as determined by ED team or study team.\n* Current ED evaluation for acute sexual assault/abuse.\n* Current mental or behavioral health symptoms precluding completion of study activities, as determined by ED team or study team.\n* Caregiver declines to step out to allow assent/consent in private or adolescent declines for caregiver to step out to allow assent/consent or participation in private.\n* Adolescent is non-English speaking.\n* Parent is non-English or non-Spanish speaking.'}, 'identificationModule': {'nctId': 'NCT05194202', 'acronym': 'ED-HEART', 'briefTitle': 'Emergency Department Healthcare Education Assessment and Response for Teen Relationships: A Pilot Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Promoting Healthy Relationships Among At-Risk Adolescents: A Feasibility Trial in the Emergency Department', 'orgStudyIdInfo': {'id': 'STUDY00001967'}, 'secondaryIdInfos': [{'id': 'K23HD098299', 'link': 'https://reporter.nih.gov/quickSearch/K23HD098299', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ED-HEART (Intervention Arm)', 'description': 'All adolescents take a baseline survey in the Emergency Department (ED), receive Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED HEART) by a trained health educator, complete an exit survey while in the ED, complete a 6-week check-in to confirm contact information and aid retention, and complete a 12-week follow up survey.', 'interventionNames': ['Behavioral: ED-HEART']}, {'type': 'NO_INTERVENTION', 'label': 'Enhanced Standard Care (Control Arm)', 'description': 'All adolescents take a baseline survey in the Emergency Department (ED), receive enhanced standard care (i.e., standard care + teen resource list), complete a 6-week check in to confirm contact information and aid retention, and complete a 12-week follow up survey.'}], 'interventions': [{'name': 'ED-HEART', 'type': 'BEHAVIORAL', 'description': 'Behavioral intervention that assesses 1) healthy and unhealthy relationship behaviors, 2) conversation with partners around boundaries within relationships, 3) harm reduction strategies, and 4) resources for Adolescent Relationship Abuse (ARA) and related concerns, including Point of Care (POC) Reproductive and Sexual Health (RSH) harm reduction resources.', 'armGroupLabels': ['ED-HEART (Intervention Arm)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospitals and Clinics", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': '12 months after study completion; indefinitely', 'ipdSharing': 'YES', 'description': 'Study information will be shared with other members on the research team. Study data will be collected and stored via the Research Electronic Data Capture (REDCap) system. De-identifiable information may also be shared with other researchers.', 'accessCriteria': 'Researchers should contact the PI (Randell) with any requests for use of the data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician, MD', 'investigatorFullName': 'Kimberly Randell', 'investigatorAffiliation': "Children's Mercy Hospital Kansas City"}}}}