Recruiting

Observational Study

Sponsor:

Washington State University

Code:

NCT06945055

Conditions

Family Members

Implementation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FAMES

Control

Study Details

Brief summary:

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.

Conditions

Family Members

Implementation

Study ID

NCT06945055

Start date

Mar 1, 2025

Status verified date

Nov, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Family Member / Support Person 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.

Exclusion Criteria:

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

Primary Service User Inclusion Criteria

  • 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

Study Design

Enrollment

900 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: 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.

active comparator: 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.

Interventions

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.

Control

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

Primary outcome measure

  • Engagement in coordinated specialty care psychoeducation [ Time Frame: Baseline through study completion; repeated measure to assess change through study completion, average of 3 months ]
  • Engagement in Family Engagement Strategy [ Time Frame: Baseline through study completion; repeated measure to assess change through study completion, average of 3 months ]

Central Contacts and Locations

Central contacts

Oladunni Oluwoye, Associate Professor, Ph.D.

509-368-6805oladunni.oluwoye@wsu.edu

Bryony Stokes, Program Manager, M.S.

509-505-7001bryony.mueller@wsu.edu

Locations

Comprehensive Healthcare

Recruiting

Pasco, Washington, United States, 99301

Contacts

Lucinda Sanchez

5094121051lucinda.sanchez@comphc.org

Lucid Living

Recruiting

Tacoma, Washington, United States, 98418

Contacts

Gregory Jones, DNP

360-539-8899gregory@transitionalcare.net

Comprehensive Healthcare

Recruiting

Yakima, Washington, United States, 98902

Contacts

Victor Larios, MSW

5095754084victor.larios@comphc.org

More Information

Sponsor

Washington State University

Last update posted

Feb 23, 2026

Last verified

Nov, 2025

Keywords

  • early psychosis
  • family peer
  • engagement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Washington State University on 2026-02-23.