FAmily Engagement Strategy for Coordinated Specialty Care

Official title

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

Overview

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

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.

Interventions

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

Primary outcome measures

• 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]

Secondary outcome measures (6)

• Perceived Stress Scale [Time frame: 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]
• Client Engagement [Time frame: 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]
• Family - Patient Health Questionnaire - 9 [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 4 centers

• Deschutes County Behavioral Health EASA — Bend
• Comprehensive Healthcare — Pasco
• Lucid Living — Tacoma
• Comprehensive Healthcare — Yakima

Publications

• 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: 10.11 PMID 41402877

Identifiers

NCT: NCT06945055 · 144707-002 · R01MH136132

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗