Improving Family Engagement in Coordinated Specialty Care for First Episode Psychosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Family Engagement in First Episode Psychosis Care

Conditions
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Family Members

Intervention / Treatment
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* Behavioral: FAMES
* Behavioral: Treatment-as-Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or older; 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 Received no more than 6 months of services Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FAMES Modification<br>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<br>* 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).<br>|
| Experimental: FAMES Pilot Trial<br>Pilot testing of FAMES and implementation toolkit | Behavioral: FAMES<br>* 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).<br>Behavioral: Treatment-as-Usual<br>* Participants will receive usual services and family-based treatment offered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | Month 1 of treatment period and month 1 follow-up period; repeated measure to assess change in acceptability and feasibility | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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). | 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) | 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) | 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. | Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coordinated Specialty Care, Family Engagement, First Episode Psychosis