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Clinical Trials/NCT04188366
NCT04188366CompletedNot Applicable

Improving Family Engagement in First Episode Psychosis Care

Washington State University2 sites in 1 country50 target enrollmentStarted: January 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Oladunni Oluwoye

Research Assistant Professor

Washington State University

Study Sites (2)

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