Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-07-24 @ 2:10 AM
Study NCT ID:
NCT03626103
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-23
First Post:
2018-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003143', 'term': 'Communication Devices for People with Disabilities'}], 'ancestors': [{'id': 'D012656', 'term': 'Self-Help Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-21', 'studyFirstSubmitDate': '2018-07-23', 'studyFirstSubmitQcDate': '2018-08-07', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Self-Efficacy Questionnaire for Children (SEQ-C)', 'timeFrame': 'Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment', 'description': 'Measures emotional self-efficacy (mean score)'}, {'measure': 'Emotional Regulation Questionnaire for Children and Adolescents (ERQ-CA)', 'timeFrame': 'Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment', 'description': 'Measures cognitive reappraisal (score is summed, range 6 - 30)'}, {'measure': 'Bosworth Violence Self-Efficacy Scale', 'timeFrame': 'Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment', 'description': 'Measures self-rated ability to stay out of violence (mean score)'}], 'primaryOutcomes': [{'measure': 'Conflict Tactics Scale-2, physical subset (CTS-2)', 'timeFrame': 'Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment', 'description': 'Change from enrollment physical peer violence (score is summed, range 0 - 56)'}, {'measure': 'Center for Epidemiologic Studies Depression Scale Revised (CESD-R)', 'timeFrame': 'Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment', 'description': 'Change from enrollment depressive symptoms (score is summed based on symptom group, range 0 - 80)'}], 'secondaryOutcomes': [{'measure': 'Change in ED Visits for Assault-Related Injury', 'timeFrame': '12 months before enrollment and 12 months after enrollment', 'description': 'Review of hospital system-wide Electronic Medical Record and state-wide Health Information Exchange to identify ED visits for peer assault'}, {'measure': 'Conflict in Adolescent Dating Relationships Inventory, physical subset (CADRI)', 'timeFrame': 'Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment', 'description': 'Change from enrollment other forms of peer violence (dating relationships)'}, {'measure': 'Illinois Bully Scale (IBS)', 'timeFrame': 'Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment', 'description': 'Change from enrollment other forms of peer violence (bullying)'}, {'measure': 'Student School Survey', 'timeFrame': 'Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment', 'description': 'Change from enrollment other forms of peer violence (bullying)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['depression', 'violence', 'emergency department', 'mhealth', 'text message'], 'conditions': ['Depressive Disorder', 'Violence']}, 'descriptionModule': {'briefSummary': 'The purpose of this investigation is to test the efficacy of "iDOVE2" (a brief emergency department introductory session and longitudinal automated text-message depression prevention program for high-risk teens), and to determine the most potent and parsimonious combination of intervention components for preventing peer violence and depressive symptoms among at-risk youth.', 'detailedDescription': 'Peer violence and depressive symptoms have mutual, reinforcing negative impacts on teens\' emotional and behavioral regulation strategies.\n\nThe emergency department (ED) is the primary source of care for many high-risk teens. It provides an opportunity to initiate preventive interventions, to complement existing mental health treatment or to stand alone for those who may lack access to formal care. Personalized text-message interventions are accessible, feasible, and may be effective with these adolescents.\n\nThe purpose of this study is to expand on the PI\'s pilot randomized controlled trial (RCT) of iDOVE (K23 MH095866; PI: Ranney) by testing the efficacy of "iDOVE2" (a brief emergency department introductory session and longitudinal automated text-message depression prevention program for high-risk teens). The investigators will use a 2x2 factorial design to determine the most potent and parsimonious combination of intervention components for preventing peer violence and depressive symptoms among at-risk youth.\n\nParticipants will be identified in the course of usual clinical care in the ED. If eligible, parents will be consented and participants assented. Participants will complete a baseline assessment and will be randomized to one of four groups: Brief ED Intervention (BI) + Text; BI + No Text; No BI + Text; or No BI + No Text. Youth in the Text arm who show no signal of improvement at 7 days, per daily self-reported mood ratings, will be re-randomized to additional "LiveText" (once-weekly real-time micro-counseling via text) or to continue with standard, automated Text intervention curriculum.\n\nAt baseline and follow-ups at 2 months, 4 months, and 8 months, participants will complete assessments on depressive symptoms, violence, cognitive/behavioral skill-sets, and resource utilization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* English-speaking\n* presenting to the emergency department for routine care\n* reporting past-year physical violence (using a modified version of The Revised Conflict Tactics Scales (CTS-2) score ≥1), as identified on a brief screen administered in the ED\n* reporting past 2-week mild-to-moderate depressive symptoms (using Patient Health Questionnaire (PHQ-9) score 5-19), as identified on a brief screen administered in the ED\n* Accompanied by a parent/guardian who is present and able to consent\n* Possession of a cell phone with text-messaging capability\n\nExclusion Criteria:\n\n* Chief complaint of suicidality, psychosis, sexual assault, or child abuse\n* In police or child protective services' custody (as per state law)\n* Unable to assent\n* In need of emergency psychiatric care"}, 'identificationModule': {'nctId': 'NCT03626103', 'acronym': 'iDOVE2', 'briefTitle': 'Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Rhode Island Hospital'}, 'officialTitle': 'A Technology-Augmented Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Emergency Department Adolescents', 'orgStudyIdInfo': {'id': 'R01HD093655', 'link': 'https://reporter.nih.gov/quickSearch/R01HD093655', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01HD093655', 'link': 'https://reporter.nih.gov/quickSearch/R01HD093655', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '+ Brief ED Intervention (BI), + Text', 'description': "Participants receive both the Brief ED Intervention component (a 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant) and the Text Message Intervention component (8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills).", 'interventionNames': ['Behavioral: + Brief ED Intervention (BI)', 'Behavioral: + Text']}, {'type': 'EXPERIMENTAL', 'label': '+ Brief ED Intervention (BI), no Text', 'description': "Participants receive the Brief ED Intervention component only (which is a 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant).", 'interventionNames': ['Behavioral: + Brief ED Intervention (BI)']}, {'type': 'EXPERIMENTAL', 'label': 'No Brief ED Intervention (BI), + Text', 'description': 'Participants receive the Text Message Intervention component only (8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills). Participants receive a brochure containing online and community resources for violence and depression prevention instead of the Brief ED Intervention component.', 'interventionNames': ['Behavioral: + Text']}, {'type': 'NO_INTERVENTION', 'label': 'No Brief ED Intervention (BI), no Text', 'description': 'Participants receive neither the Brief ED Intervention component, nor the Text Message Intervention component. Participants receive a brochure containing online and community resources for violence and depression prevention, instead of the Brief ED Intervention component.'}], 'interventions': [{'name': '+ Brief ED Intervention (BI)', 'type': 'BEHAVIORAL', 'description': "Brief ED Intervention (BI): A 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant", 'armGroupLabels': ['+ Brief ED Intervention (BI), + Text', '+ Brief ED Intervention (BI), no Text']}, {'name': '+ Text', 'type': 'BEHAVIORAL', 'description': 'Text: 8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills. Those that do not show improvement in mood after 7 days will be randomized into LiveText.', 'armGroupLabels': ['+ Brief ED Intervention (BI), + Text', 'No Brief ED Intervention (BI), + Text']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': "Rhode Island Hospital/Hasbro Children's Hospital", 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Megan L Ranney, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale School of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhode Island Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}