search
Back to results

Improving Family Engagement in Coordinated Specialty Care for First Episode Psychosis

Primary Purpose

Family Members

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FAMES
Treatment-as-Usual
Sponsored by
Washington State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Family Members focused on measuring Coordinated Specialty Care, Family Engagement, First Episode Psychosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

  • New Journeys: Coordinated specialty careRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

FAMES Modification

FAMES Pilot Trial

Arm Description

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

Pilot testing of FAMES and implementation toolkit

Outcomes

Primary Outcome Measures

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.
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.
Qualitative interviews
Interviews with providers and family member participants to assess acceptability and of FAMES

Secondary Outcome Measures

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
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).
Burden Assessment Scale (BAS)
Self-report measure to assess family functioning. Total possible scores range from 10 to 171 (higher scores indicating greater burden)
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)
Treatment Self-Regulation Questionnaire (TSRQ)
Self-report measure to assess motivation. Scale ranges from 1=not at all true to 7=very true.

Full Information

First Posted
November 27, 2019
Last Updated
August 22, 2022
Sponsor
Washington State University
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT04188366
Brief Title
Improving Family Engagement in Coordinated Specialty Care for First Episode Psychosis
Official Title
Improving Family Engagement in First Episode Psychosis Care
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington State University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Family Members
Keywords
Coordinated Specialty Care, Family Engagement, First Episode Psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FAMES Modification
Arm Type
Experimental
Arm Description
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
Arm Title
FAMES Pilot Trial
Arm Type
Experimental
Arm Description
Pilot testing of FAMES and implementation toolkit
Intervention Type
Behavioral
Intervention Name(s)
FAMES
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Treatment-as-Usual
Intervention Description
Participants will receive usual services and family-based treatment offered
Primary Outcome Measure Information:
Title
Client Satisfaction Questionnaire-8 (CSQ-8)
Description
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.
Time Frame
Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Title
Youth Services Survey-Families (YSS-F)
Description
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.
Time Frame
Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Title
Qualitative interviews
Description
Interviews with providers and family member participants to assess acceptability and of FAMES
Time Frame
Month 1 of treatment period and month 1 follow-up period; repeated measure to assess change in acceptability and feasibility
Secondary Outcome Measure Information:
Title
Level of Engagement to measure effectiveness of FAMES
Description
Provider reported service utilization. Total number of contact hours between provider and family member to measure engagement
Time Frame
Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Title
Rate of Retention to measure effectiveness of FAMES
Description
Provider reported service utilization. Percentage of families that dropout (family member declined or missed three consecutive appointments).
Time Frame
Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Title
Burden Assessment Scale (BAS)
Description
Self-report measure to assess family functioning. Total possible scores range from 10 to 171 (higher scores indicating greater burden)
Time Frame
Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Title
Iowa Cultural Understanding Assessment
Description
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)
Time Frame
Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Title
Treatment Self-Regulation Questionnaire (TSRQ)
Description
Self-report measure to assess motivation. Scale ranges from 1=not at all true to 7=very true.
Time Frame
Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Other Pre-specified Outcome Measures:
Title
Organizational Readiness to Change Assessment (ORCA)
Description
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
Time Frame
Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oladunni Oluwoye, PhD
Phone
(509)368-6805
Email
Oladunni.oluwoye@wsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bryony Stokes, BA
Phone
(509) 505-7001
Email
bryony.mueller@wsu.edu
Facility Information:
Facility Name
New Journeys: Coordinated specialty care
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Daughtry

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32847910
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.
Results Reference
derived

Learn more about this trial

Improving Family Engagement in Coordinated Specialty Care for First Episode Psychosis

We'll reach out to this number within 24 hrs