FAmily Engagement Strategy for Coordinated Specialty Care

NCT06945055 | Recruiting DMC

• 2 other identifiers: 144707-002R01MH136132
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 4

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

Keywords

early psychosis; family peer; engagement

Outcome Measures

Primary Outcomes (2)

• Engagement in coordinated specialty care psychoeducation

  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

  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 Outcomes (6)

• Perceived Stress Scale

  Baseline through study completion; repeated measure to assess change through study completion, average of 6 months

• General Anxiety Disorder - 7

  Baseline through study completion; repeated measure to assess change through study completion, average of 6 months

• Client Engagement

  Baseline through study completion; repeated measure to assess change through study completion, average of 6 months

• Client - Patient Health Questionnaire - 9

  Baseline through study completion; repeated measure to assess change through study completion, average of 6 months

• Family - Patient Health Questionnaire - 9

  Baseline through study completion; repeated measure to assess change through study completion, average of 6 months

Other Outcomes (3)

• General Self-Efficacy Scale

  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

  Baseline and Month 3 of treatment period; repeated measure to assess change through study completion, an average of 3 months

• Treatment Motivation Questionnaire

  Baseline and Month 3 of treatment period; repeated measure to assess change through study completion, an average of 3 months

Study Arms (2)

Attention Control Condition

ACTIVE COMPARATOR

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

Active Condition

ACTIVE COMPARATOR

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

Interventions

FAMES 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.

Active Condition

Control BEHAVIORAL

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

Attention Control Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• If they do not understand the consent process.
• If they do not speak and/or understand English or Spanish.
• enrolled in coordinated specialty care services for less than or equal to 6 months.
• 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.
• if they do not understand the consent process
• If they do not speak and/or understand English or Spanish

Sponsors & Collaborators

• Washington State University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

Deschutes County Behavioral Health EASA

Bend, Oregon, 97703, United States

NOT YET RECRUITING

Comprehensive Healthcare

Pasco, Washington, 99301, United States

RECRUITING

Lucid Living

Tacoma, Washington, 98418, United States

RECRUITING

Comprehensive Healthcare

Yakima, Washington, 98902, United States

RECRUITING

Related Publications (1)

• Oluwoye O, Stokes B, Crisanti AS, Garcia KS, Kriegel L, Puzia M, Sanchez AL, Shelton RC, Weeks DL. FAMily Motivational Engagement Strategy (FAMES) for coordinated specialty care programs: study protocol to evaluate a culturally responsive engagement intervention and equity focused implementation strategies in a hybrid type 2 randomized stepped-wedge trial. Trials. 2025 Dec 16;26(1):568. doi: 10.1186/s13063-025-09280-0.

  PMID: 41402877 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Oladunni Oluwoye, Associate Professor, Ph.D.

CONTACT

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

Bryony Stokes, Program Manager, M.S.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 25, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 23, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)