FAmily Engagement Strategy for Coordinated Specialty Care

NCT ID: NCT06945055

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2029-12-31

Brief Summary

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Family members/support persons' engagement in mental health services has been linked to reduced burden and stress and improves engagement and outcomes in individuals in the early stages of psychosis. The goal of FAMES is to address low family member/support person engagement in services. FAMES will also address disparities in coordinated specialty care (CSC) by using a culturally responsive family engagement strategy to be delivered by family peers.

Detailed Description

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The overall goal of this mixed-methods, clustered stepped-wedged designed study is to examine the effectiveness of a family peer implemented in coordinated specialty care programs at engaging family members in services. The use of a family peer is anticipated to increase family member participant's feelings of connectedness, self-efficacy, and motivation which will in turn improve family member participants engagement in scheduled coordinated specialty care services such as family psychoeducation.

Recruitment will consist of dyads compromised of a family member support person and a corresponding individual receiving coordinated specialty care services. Recruitment will occur over two waves, the attention control condition (ACC) and the FAMES condition. The ACC will last for 18 months and will recruit 225 participant dyads during which time family member participants will be contacted weekly for 12 weeks where they will be provided with positively framed messaging, educational materials around psychosis, tips for addressing relevant concerns in areas such as communication and de-escalation, and a list of community-based and online resources and events. The FAMES condition will last for 30 months and will recruit 225 participant dyads during which time family member participants will receive a modified cultural formulation interview, brief check-ins, psychoeducation, and will have access to an online community.

Recruitment will take place at nine coordinated specialty care programs across four states (Washington, Oregon, Tennessee, and New Mexico) which have been randomized to a clustered stepped wedge program design.

Conditions

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Family Members Implementation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

A cluster randomized stepped wedge design with an attention control condition (n=225 dyads) lasting 18 months and an active implementation condition (n=225 dyads) lasting 30 months.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Attention Control Condition

225 dyads (family members/support persons and individuals receiving services for psychosis) will be recruited over a period of 18 months to receive 12 weeks of weekly communication via text, email or phone call, which includes positive messaging, community resources, appointment reminders, and psychoeducation.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

participants will receive 12 weeks of automated communication which contain positive messaging, appointment reminders, links to community resources, and coping skills.

Active Condition

This arm lasts for 30 months during each wave of the clustered randomized stepped wedge design. 225 participants will receive the FAMES intervention.

Group Type ACTIVE_COMPARATOR

FAMES

Intervention Type BEHAVIORAL

225 dyads (family member/support persons and individuals receiving services for psychosis) will be recruited over a period of 30 months. Family member/support persons will be connected to a family peer for a period of 12 weeks who will use the cultural formulated interview to develop rapport and identify unique cultural needs which can inform treatment and resource identification. Participants will receive brief contact, family psychoeducation, and be connected to an online family resource group where they can receive additional support from certified peers and other family member/support persons.

Interventions

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FAMES

225 dyads (family member/support persons and individuals receiving services for psychosis) will be recruited over a period of 30 months. Family member/support persons will be connected to a family peer for a period of 12 weeks who will use the cultural formulated interview to develop rapport and identify unique cultural needs which can inform treatment and resource identification. Participants will receive brief contact, family psychoeducation, and be connected to an online family resource group where they can receive additional support from certified peers and other family member/support persons.

Intervention Type BEHAVIORAL

Control

participants will receive 12 weeks of automated communication which contain positive messaging, appointment reminders, links to community resources, and coping skills.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Family member/support person of an individual enrolled in coordinated specialty care services for less than or equal to 6 months.
* 18 years of age or older.
* During the active implementation period (FAMES) did not participate in the attention control condition.


* enrolled in coordinated specialty care services for less than or equal to 6 months.
* 15 years of age or older.
* Has a family member/support person willing to engage in the study. during the active implementation period (FAMES) did not participate in the attention control condition.

Exclusion Criteria

* If they do not understand the consent process.
* If they do not speak and/or understand English or Spanish.


* if they do not understand the consent process
* If they do not speak and/or understand English or Spanish
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Washington State University

OTHER

Sponsor Role lead

Responsible Party

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Oladunni Oluwoye

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Deschutes County Behavioral Health EASA

Bend, Oregon, United States

Site Status NOT_YET_RECRUITING

Comprehensive Healthcare

Pasco, Washington, United States

Site Status RECRUITING

Lucid Living

Tacoma, Washington, United States

Site Status RECRUITING

Comprehensive Healthcare

Yakima, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Oladunni Oluwoye, Associate Professor, Ph.D.

Role: CONTACT

509-368-6805

Bryony Stokes, Program Manager, M.S.

Role: CONTACT

509-505-7001

Facility Contacts

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Shannon Brister-Raugust

Role: primary

541-322-7545

Lucinda Sanchez

Role: primary

509-412-1051

Gregory Jones, DNP

Role: primary

360-539-8899

Victor Larios, MSW

Role: primary

509-575-4084

Other Identifiers

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R01MH136132

Identifier Type: NIH

Identifier Source: secondary_id

View Link

144707-002

Identifier Type: -

Identifier Source: org_study_id

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