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NCT Number: NCT06945055

FAmily Engagement Strategy for 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.

Recruiting

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Key information

Conditions

Family Members Implementation Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deschutes County Behavioral Health EASA, Bend, Oregon, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bryony Stokes, Program Manager, M.S.

CONTACT

[email protected]

509-505-7001

Oladunni Oluwoye, Associate Professor, Ph.D.

CONTACT

[email protected]

509-368-6805

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: FAMES

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 25, 2025
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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