FAmily Engagement Strategy for Coordinated Specialty Care (FAMES)

February 19, 2026 updated by: Oladunni Oluwoye, Washington State University

Integration of a Culturally Responsive Family Peer Delivered Engagement Strategy in Coordinated Specialty Care

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Oregon
      • Bend, Oregon, United States, 97703
        • Not yet recruiting
        • Deschutes County Behavioral Health EASA
        • Contact:
    • Washington
      • Pasco, Washington, United States, 99301
      • Tacoma, Washington, United States, 98418
      • Yakima, Washington, United States, 98902
        • Recruiting
        • Comprehensive Healthcare
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Control
participants will receive 12 weeks of automated communication which contain positive messaging, appointment reminders, links to community resources, and coping skills.
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engagement in coordinated specialty care psychoeducation
Time Frame: Baseline through study completion; repeated measure to assess change through study completion, average of 3 months
Will be measured as first session attendance rate and total attendance rate per family provided by administrative data from the coordinated specialty care site partners.
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
Total number of Family Engagement Strategy session attended and the total number of contact minutes to measure engagement.
Baseline through study completion; repeated measure to assess change through study completion, average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale
Time Frame: Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
A self-report measure which includes 10 Likert-style items to assess the degree to which an individual appraises life as stressful. Scores range from 0-40 where scores greater that 13 indicate moderate to high perceived stress.
Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
General Anxiety Disorder - 7
Time Frame: Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
Self-report measure to assess symptoms of anxiety. Scores range from 0-21 where scores greater than 10 are indicative of clinically significant anxiety.
Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
Client Engagement
Time Frame: Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
Provider reported service utilization. Total number of appointments attended.
Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
Client - Patient Health Questionnaire - 9
Time Frame: Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
A self-report from the individual receiving coordinated specialty care services on their symptoms of depression. Scores range from 0-27 where any score 10 or greater is indicative of clinically significant symptoms of depression.
Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
Family - Patient Health Questionnaire - 9
Time Frame: Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
A self-report from the family member participant on their symptoms of depression. Scores range from 0-27 where any score 10 or greater is indicative of clinically significant symptoms of depression.
Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
Community Assessment of Psychic Experiences - Positive Scale 15-items Scale
Time Frame: Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
A self-report measure from the individual receiving the coordinated specialty care services. Scores range from 0-3 where scores greater than 1.46 indicate clinically significant symptoms of psychosis.
Baseline through study completion; repeated measure to assess change through study completion, average of 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
General Self-Efficacy Scale
Time Frame: Baseline and Month 3 of treatment period; repeated measure to assess change through study completion, an average of 3 months
A self-report 10-item measure completed by the family member participant. Scores range from 10-40 with higher scores indicating greater self-efficacy.
Baseline and Month 3 of treatment period; repeated measure to assess change through study completion, an average of 3 months
Social Connectedness subscale of the Youth Services Survey - Families
Time Frame: Baseline and Month 3 of treatment period; repeated measure to assess change through study completion, an average of 3 months
Social connectedness will be measured using four questions (e.g., "I know people who will listen and understand me when I need to talk") from the YSS-F. Scores range from 4 to 20, higher scores indicating greater social connectedness.
Baseline and Month 3 of treatment period; repeated measure to assess change through study completion, an average of 3 months
Treatment Motivation Questionnaire
Time Frame: Baseline and Month 3 of treatment period; repeated measure to assess change through study completion, an average of 3 months
A self-report measure completed by the family member/support person participant. Includes 26 Likert-scale questions to assess motivation about services. Scores range from 27 to 182 where greater scores indicated greater motivation.
Baseline and Month 3 of treatment period; repeated measure to assess change through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington State University

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 144707-002
  • R01MH136132 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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