Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-11 @ 11:43 PM
Study NCT ID:
NCT03799302
Status:
COMPLETED
Last Update Posted:
2023-11-01
First Post:
2018-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Facilitating Sustainment Through Implementation Feedback: The SIC Coaching Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-05-22', 'releaseDate': '2024-04-24'}, {'resetDate': '2024-07-31', 'releaseDate': '2024-07-05'}], 'estimatedResultsFirstSubmitDate': '2024-04-24'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2018-12-13', 'studyFirstSubmitQcDate': '2019-01-08', 'lastUpdatePostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stages of Implementation Completion (SIC)', 'timeFrame': 'Baseline through month 60', 'description': 'The SIC is an 8-stage observational assessment tool recording organizational site completion of implementation activities that map onto the three phases of implementation (Pre-Implementation, Implementation, Sustainability).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Evidence Based Practice']}, 'descriptionModule': {'briefSummary': 'This study aims to test the impact of an empirically derived implementation strategy-under real-world conditions and across multiple child service systems-on successful adoption and sustainment of two evidence-based programs that address adolescent substance abuse: Treatment Foster Care Oregon (TFCO; formerly Multidimensional Treatment Foster Care) and Multidimensional Family Therapy (MDFT), both developed with funding from NIDA. Methods for this study utilize "technology-based approaches" for "implementing large-scale change." Leveraging previous data focused on developing and testing the 8-staged Stages of Implementation Completion (SIC) tool, a randomized evaluation of a SIC Coaching Strategy (SIC-CS) is proposed. Study activities include extending the SIC into the Sustainment Phase and testing the SIC-CS to support the adoption of new evidence-based programs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Senior leadership staff from teams that either currently are sustaining or who achieve 1-year sustainment post certification during the first year of the project\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03799302', 'briefTitle': 'Facilitating Sustainment Through Implementation Feedback: The SIC Coaching Model', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Social Learning Center'}, 'officialTitle': 'Facilitating Sustainment Through Implementation Feedback: The SIC Coaching Model', 'orgStudyIdInfo': {'id': 'R01DA044745', 'link': 'https://reporter.nih.gov/quickSearch/R01DA044745', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Consultation', 'description': 'Sites in this arm will receive the standard consultation from the TFCO or MDFT purveyors'}, {'type': 'EXPERIMENTAL', 'label': 'SIC Coaching Consultation', 'description': 'In addition to the standard consultation from the TFCO or MDFT purveyors, sites in this arm will also receive feedback on how they are doing in terms of completing expected activities in their efforts to implement the designated EBP.', 'interventionNames': ['Behavioral: SIC Coaching']}], 'interventions': [{'name': 'SIC Coaching', 'type': 'BEHAVIORAL', 'description': 'Sites receiving consultation to implement either TFCO or MDFT will also receive consultation on their implementation fidelity as measured and tracked by the SIC.', 'armGroupLabels': ['SIC Coaching Consultation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Social Learning Center', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}], 'overallOfficials': [{'name': 'Lisa Saldana, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Social Learning Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Social Learning Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lisa Saldana', 'investigatorAffiliation': 'Oregon Social Learning Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-04-24', 'type': 'RELEASE'}, {'date': '2024-05-22', 'type': 'RESET'}, {'date': '2024-07-05', 'type': 'RELEASE'}, {'date': '2024-07-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Lisa Saldana, Principal Investigator, Oregon Social Learning Center'}}}}