Improving Family Engagement in Coordinated Specialty Care for First Episode Psychosis

Family Members Clinical Trial

Official title:

Improving Family Engagement in First Episode Psychosis Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04188366
• Other study ID #: 17761-001
• Secondary ID: K01MH117457-01A1
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2022
• Source: Washington State University
• Contact: Oladunni Oluwoye, PhD
• Phone: (509)368-6805
• Email: Oladunni.oluwoye[@]wsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Family Members
• Mental Disorders
• Psychotic Disorders

Intervention

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).
• Treatment-as-Usual
Participants will receive usual services and family-based treatment offered

Locations

Country	Name	City	State
United States	New Journeys: Coordinated specialty care	Yakima	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Washington State University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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