Clinical trial NCT04188366: Improving Family Engagement in Coordinated Specialty Care for First Episode Psychosis
Official title: Improving Family Engagement in First Episode Psychosis Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Members
Keywords: Coordinated Specialty Care
Family Engagement
First Episode Psychosis
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-12-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or older;
2. 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
3. Received no more than 6 months of services

Exclusion Criteria:

Primary outcomes:
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
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
measure: Qualitative interviews
timeFrame: Month 1 of treatment period and month 1 follow-up period; repeated measure to assess change in acceptability and feasibility
Secondary outcomes:
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
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
measure: Burden Assessment Scale (BAS)
timeFrame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
measure: Iowa Cultural Understanding Assessment
timeFrame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
measure: Treatment Self-Regulation Questionnaire (TSRQ)
timeFrame: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Other outcomes:
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
Locations:
city: Yakima
country: United States
facility: New Journeys: Coordinated specialty care
state: Washington
Study officials:
References:
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.