Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-25 @ 2:26 PM
Study NCT ID:
NCT04188366
Status:
COMPLETED
Last Update Posted:
2025-04-20
First Post:
2019-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Family Engagement in Coordinated Specialty Care for First Episode Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2019-11-27', 'studyFirstSubmitQcDate': '2019-12-04', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Organizational Readiness to Change Assessment (ORCA)', 'timeFrame': 'Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion', 'description': 'Self-report provider measure to assess assess evidence assessment, contextual readiness and facilitation needs. All items are scored from 1=strongly disagree to 5=strongly agree'}], 'primaryOutcomes': [{'measure': 'Client Satisfaction Questionnaire-8 (CSQ-8)', 'timeFrame': 'Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion', 'description': 'Self-report measure to assess acceptability, a brief measure for family member participant. Items are scored from 1 to 4. Possible total scores range from 8 to 32, with higher scores (\\>23) indicating greater satisfaction.'}, {'measure': 'Youth Services Survey-Families (YSS-F)', 'timeFrame': 'Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion', 'description': 'Self-report measure to assess acceptability in the following domains: appropriateness, participation, cultural sensitivity, social connectedness, and outcomes. Items in a domain are summed and divided by the total number of items, and scores greater than 3.5 are reported in the positive range for the domain.'}, {'measure': 'Qualitative interviews', 'timeFrame': 'Month 1 of treatment period and month 1 follow-up period; repeated measure to assess change in acceptability and feasibility', 'description': 'Interviews with providers and family member participants to assess acceptability and of FAMES'}], 'secondaryOutcomes': [{'measure': 'Level of Engagement to measure effectiveness of FAMES', 'timeFrame': 'Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion', 'description': 'Provider reported service utilization. Total number of contact hours between provider and family member to measure engagement'}, {'measure': 'Rate of Retention to measure effectiveness of FAMES', 'timeFrame': 'Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion', 'description': 'Provider reported service utilization. Percentage of families that dropout (family member declined or missed three consecutive appointments).'}, {'measure': 'Burden Assessment Scale (BAS)', 'timeFrame': 'Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion', 'description': 'Self-report measure to assess family functioning. Total possible scores range from 10 to 171 (higher scores indicating greater burden)'}, {'measure': 'Iowa Cultural Understanding Assessment', 'timeFrame': 'Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion', 'description': 'Self-report measure to assess provider cultural competence. All items are scored from 1=strongly disagree to 5=strongly agree. Total scores range from 25 to 125 (higher scores indicating great cultural competence)'}, {'measure': 'Treatment Self-Regulation Questionnaire (TSRQ)', 'timeFrame': 'Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion', 'description': 'Self-report measure to assess motivation. Scale ranges from 1=not at all true to 7=very true.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coordinated Specialty Care', 'Family Engagement', 'First Episode Psychosis'], 'conditions': ['Family Members']}, 'referencesModule': {'references': [{'pmid': '32847910', 'type': 'DERIVED', 'citation': 'Oluwoye O, Dyck D, McPherson SM, Lewis-Fernandez R, Compton MT, McDonell MG, Cabassa LJ. Developing and implementing a culturally informed FAmily Motivational Engagement Strategy (FAMES) to increase family engagement in first episode psychosis programs: mixed methods pilot study protocol. BMJ Open. 2020 Aug 26;10(8):e036907. doi: 10.1136/bmjopen-2020-036907.'}]}, 'descriptionModule': {'briefSummary': 'Investigators aim to develop and evaluate a culturally informed family motivational engagement strategy (FAMES) and implementation toolkit for coordinated specialty care (CSC) programs for first episode psychosis. First, 5 family member participants will be recruited into a three-month trial of FAMES and implementation toolkit. The investigators will then conduct a 16-month non-randomized, stepped-wedge trial with 50 family members from 5 CSC programs in community-based mental health clinics.', 'detailedDescription': 'FAMES involves three distinct and revolving components - early, continuous, and motivational contact - that incorporate motivational techniques and the Diagnostic and Statistical Manual of Mental Disorders 5TH Edition (DSM-5) Cultural Formulation Interview (CFI).\n\nThe overarching objective of this study is to assess the feasibility and acceptability of a brief provider-led FAmily Engagement Motivational Strategy (FAMES) and its accompanying implementation toolkit. The investigators will also preliminary examine whether FAMES improves family engagement and retention in treatment, and motivation.\n\nA total of 50 participants with a loved one enrolled in CSC program for FEP will be recruited from five CSC programs in Washington State to take part in a non-randomized stepped-wedge pilot trial. Each CSC program will represent a cluster and serve as its own control. A two-month implementation transition period will occur at each CSC program and during which providers will be introduced to the intervention using the implementation toolkits and trained to conduct FAMES. A 12-month open cohort design will be utilized to recruit approximately 50 family members during the study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 years or older;\n2. One family member (e.g., parent, guardian, aunt, uncle, spouse, grandparent, sibling, close friend) of an individual enrolled in a Washington State CSC program; and\n3. Received no more than 6 months of services\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT04188366', 'briefTitle': 'Improving Family Engagement in Coordinated Specialty Care for First Episode Psychosis', 'organization': {'class': 'OTHER', 'fullName': 'Washington State University'}, 'officialTitle': 'Improving Family Engagement in First Episode Psychosis Care', 'orgStudyIdInfo': {'id': '17761-001'}, 'secondaryIdInfos': [{'id': 'K01MH117457-01A1', 'link': 'https://reporter.nih.gov/quickSearch/K01MH117457-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FAMES Modification', 'description': '3-month trial of FAMES. Results from modifications will be used to by stakeholders (i.e., family members, client, providers, organizational leadership,) to inform finalization and implementation of FAMES', 'interventionNames': ['Behavioral: FAMES']}, {'type': 'EXPERIMENTAL', 'label': 'FAMES Pilot Trial', 'description': 'Pilot testing of FAMES and implementation toolkit', 'interventionNames': ['Behavioral: FAMES', 'Behavioral: Treatment-as-Usual']}], 'interventions': [{'name': 'FAMES', 'type': 'BEHAVIORAL', 'description': 'Participants will receive three distinct and revolving components - early, continuous, and motivational contact - that incorporate motivational techniques and the Diagnostic and Statistical Manual of Mental Disorders 5TH Edition (DSM-5) Cultural Formulation Interview (CFI).', 'armGroupLabels': ['FAMES Modification', 'FAMES Pilot Trial']}, {'name': 'Treatment-as-Usual', 'type': 'BEHAVIORAL', 'description': 'Participants will receive usual services and family-based treatment offered', 'armGroupLabels': ['FAMES Pilot Trial']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98902', 'city': 'Yakima', 'state': 'Washington', 'country': 'United States', 'facility': 'New Journeys: Coordinated specialty care', 'geoPoint': {'lat': 46.60207, 'lon': -120.5059}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Oladunni Oluwoye', 'investigatorAffiliation': 'Washington State University'}}}}