Improving Family Engagement in First Episode Psychosis Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Washington State University
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Client Satisfaction Questionnaire-8 (CSQ-8)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
Primary Outcomes
Client Satisfaction Questionnaire-8 (CSQ-8)
Time Frame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
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.
Youth Services Survey-Families (YSS-F)
Time Frame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
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.
Qualitative interviews
Time Frame: Month 1 of treatment period and month 1 follow-up period; repeated measure to assess change in acceptability and feasibility
Interviews with providers and family member participants to assess acceptability and of FAMES
Secondary Outcomes
- Rate of Retention to measure effectiveness of FAMES(Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion)
- Level of Engagement to measure effectiveness of FAMES(Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion)
- Burden Assessment Scale (BAS)(Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion)
- Iowa Cultural Understanding Assessment(Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion)
- Treatment Self-Regulation Questionnaire (TSRQ)(Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion)
Investigators
Oladunni Oluwoye
Research Assistant Professor
Washington State University