Improving Family Engagement in Coordinated Specialty Care for First Episode Psychosis

Improving Family Engagement in First Episode Psychosis Care

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.

Study Overview

• Status: Completed
• Conditions: Family Members
• Intervention / Treatment: Behavioral: FAMES; Behavioral: Treatment-as-Usual

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Yakima, Washington, United States, 98902
      • New Journeys: Coordinated Specialty care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Washington State University
• Collaborators: National Institute of Mental Health (NIMH)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Family Engagement; First Episode Psychosis; Coordinated Specialty Care
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 17761-001; K01MH117457-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No