Improving Family Engagement in Coordinated Specialty Care for First Episode Psychosis

NCT04188366 | Completed DMC

• 2 other identifiers: 17761-001K01MH117457-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Family Members

Keywords

Coordinated Specialty Care; Family Engagement; First Episode Psychosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

• 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

• 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

Other Outcomes (1)

• Organizational Readiness to Change Assessment (ORCA)

  Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion

Study Arms (2)

FAMES Modification

EXPERIMENTAL

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

FAMES Pilot Trial

EXPERIMENTAL

Pilot testing of FAMES and implementation toolkit

Behavioral: FAMES; Behavioral: Treatment-as-Usual

Interventions

FAMES BEHAVIORAL

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).

FAMES Modification; FAMES Pilot Trial

Treatment-as-Usual BEHAVIORAL

Participants will receive usual services and family-based treatment offered

FAMES Pilot Trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Washington State University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New Journeys: Coordinated specialty care

Yakima, Washington, 98902, United States

Location

Related Publications (1)

• 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.

  PMID: 32847910 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 5, 2019
• Study Start: January 1, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)