An interventional study of FAMES and Treatment-as-Usual in Family Members, sponsored by Washington State University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-20.
Sponsored by Washington State University · Not applicable, Interventional, and Treatment
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.
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).
The 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.
A 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.
1,626 studies on the registry are indexed under Psychotic Disorders; 293 are open to participants now.
This study's enrollment of 50 is below the median of 70 across 1,333 interventional studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →Washington State University is the lead sponsor of 82 studies on the registry; 16 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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Exclusion Criteria:
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
Behavioral: FAMES
Pilot testing of FAMES and implementation toolkit
Behavioral: FAMES · Behavioral: Treatment-as-Usual
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).
Participants will receive usual services and family-based treatment offered
Client Satisfaction Questionnaire-8 (CSQ-8)
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.
Time frame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Youth Services Survey-Families (YSS-F)
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.
Time frame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Qualitative interviews
Interviews with providers and family member participants to assess acceptability and of FAMES
Time frame: Month 1 of treatment period and month 1 follow-up period; repeated measure to assess change in acceptability and feasibility
Level of Engagement to measure effectiveness of FAMES
Provider reported service utilization. Total number of contact hours between provider and family member to measure engagement
Time frame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Rate of Retention to measure effectiveness of FAMES
Provider reported service utilization. Percentage of families that dropout (family member declined or missed three consecutive appointments).
Time frame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Burden Assessment Scale (BAS)
Self-report measure to assess family functioning. Total possible scores range from 10 to 171 (higher scores indicating greater burden)
Time frame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Iowa Cultural Understanding Assessment
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)
Time frame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Treatment Self-Regulation Questionnaire (TSRQ)
Self-report measure to assess motivation. Scale ranges from 1=not at all true to 7=very true.
Time frame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Organizational Readiness to Change Assessment (ORCA)
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
Time frame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Plan to share: No
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Washington State University