Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-25 @ 7:00 PM
Study NCT ID:
NCT05567250
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2022-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing a Scalable Model For ACEs-Related Care Navigation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2022-09-28', 'studyFirstSubmitQcDate': '2022-10-03', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Referrals to ACEs-related services', 'timeFrame': '2-6 months after enrollment', 'description': 'The percentage of children who are referred to at least one ACEs-related service, as reported on the participant survey.'}], 'secondaryOutcomes': [{'measure': 'Receipt of ACEs-related services', 'timeFrame': '2-6 months after enrollment', 'description': 'The percentage of children who receive at least one ACEs-related service, as reported on the participant survey.'}, {'measure': 'Number of referrals received', 'timeFrame': '2-6 months after enrollment', 'description': 'The number of referrals made for ACEs-related services, as reported on the participant survey.'}, {'measure': 'Number of services received', 'timeFrame': '2-6 months after enrollment', 'description': 'The number of ACEs-related services received, as reported on the participant survey.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Health Services Research', 'Care Coordination'], 'conditions': ['Adverse Childhood Experiences', 'Child Development']}, 'referencesModule': {'references': [{'pmid': '30894408', 'type': 'BACKGROUND', 'citation': 'Nelson BB, Thompson LR, Herrera P, Biely C, Arriola Zarate D, Aceves I, Estrada I, Chan V, Orantes C, Chung PJ. Telephone-Based Developmental Screening and Care Coordination Through 2-1-1: A Randomized Trial. Pediatrics. 2019 Apr;143(4):e20181064. doi: 10.1542/peds.2018-1064.'}, {'pmid': '41161485', 'type': 'DERIVED', 'citation': 'Lim Chang C, Chung PJ, Ngan H, Porras-Javier L, Vangala S, Correa-Mendoza L, Calderon K, Thompson LR, Molina D, Aceves I, Torres F, Dudovitz R. Testing a Scalable Model for Adverse Childhood Experiences-Related Care Coordination via 211 Telephone-Based Services. Acad Pediatr. 2025 Oct 27;26(1):103160. doi: 10.1016/j.acap.2025.103160. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The study is a randomized controlled trial of a telephone-based care coordination system for families who experienced Adverse Childhood Events (ACEs). The investigators will conduct the study in partnership with Kaiser Permanente School of Medicine (KPSOM) and 2-1-1 Los Angeles County (211LA), part of a national network of 2-1-1 call centers covering 93% of the US population. The study will test the effectiveness of 211LA in increasing referrals and services for families who screen positive for ACEs.', 'detailedDescription': 'The trial will enroll 200 children ages 0-11 years from the three FQHCs partner clinics, who screen positive for at least 1 ACE during their clinical encounter. The research study team will randomize children 1:1 into intervention (connection to 211LA for ACEs care coordination + usual care) or control (usual care alone).\n\nPrimary outcomes will include number of referrals to, eligibility for, and receipt of ACE-related services among intervention group participants compared to controls.\n\nThe investigators will measure these outcomes through parent reported data and 211LA data at baseline and 6 months after enrollment.\n\nExpected findings include higher referral and service rates by six months after enrollment among intervention group participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A patient in one of the three partner community clinic systems (ChapCare, Via Care and NEVHC)\n* Child aged 0 - 11 years old\n* Parent or legal guardian of child at least 18 years of age\n* Comfortable completing a survey by interview in English or Spanish\n\nExclusion Criteria:\n\n* Child or sibling already enrolled in this study\n* Child or sibling enrolled in the AMP Child Development study'}, 'identificationModule': {'nctId': 'NCT05567250', 'briefTitle': 'Testing a Scalable Model For ACEs-Related Care Navigation', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Testing a Scalable Model For ACEs-Related Care Navigation Via 211 Telephone-Based Services', 'orgStudyIdInfo': {'id': '22-000405'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Intervention + Usual Care', 'description': 'Intervention group families will receive usual care and they will be connected via telephone to 211LA.', 'interventionNames': ['Behavioral: Behavioral: Telephone-based ACEs care coordination']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention: Usual Care', 'description': 'This group will receive usual care'}], 'interventions': [{'name': 'Behavioral: Telephone-based ACEs care coordination', 'type': 'BEHAVIORAL', 'description': "The 211LA care coordinator will use the agency's extensive resource directory to identify and provide appropriate referral recommendations to each family. In addition, they will develop a care coordination plan, noting these recommendations and plans for follow-up, to be provided to the family's clinical care provider. The coordinator will routinely follow-up with the family until 1) children begin receiving services, 2) families refuse services, or 3) children are deemed ineligible by service providers.", 'armGroupLabels': ['Experimental Intervention + Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Rebecca Dudovitz, MD MSHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be shared within 2 years of study completion.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data for all primary and secondary outcome measures will be shared.', 'accessCriteria': 'Proposals should be directed to lporras@mednet.ucla.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website, to be provided when requests are approved.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kaiser Permanente School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Rebecca Dudovitz, MD, MSHS', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}