FAmily Engagement Strategy for Coordinated Specialty Care (FAMES)

Washington State University

Status: Enrolling

Conditions: Family Members; Implementation

Treatments: Behavioral: FAMES; Behavioral: Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06945055

144707-002

R01MH136132 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Family member/support person of an individual enrolled in coordinated specialty care services for equal to or less than 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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 2 patient groups

Attention Control Condition

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control

Active Condition

Active Comparator group

Description:

This arm lasts for 30 months during each wave of the clustered randomized stepped wedge design. 225 participants will receive the FAMES intervention.

Treatment:

Behavioral: FAMES