Clinical trial NCT06945055: FAmily Engagement Strategy for Coordinated Specialty Care
Official title: Integration of a Culturally Responsive Family Peer Delivered Engagement Strategy in Coordinated Specialty Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Family Members
Implementation
Keywords: early psychosis
family peer
engagement
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-04-25
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Engagement in coordinated specialty care psychoeducation
timeFrame: Baseline through study completion; repeated measure to assess change through study completion, average of 3 months
measure: Engagement in Family Engagement Strategy
timeFrame: Baseline through study completion; repeated measure to assess change through study completion, average of 3 months
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
measure: General Anxiety Disorder - 7
timeFrame: Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
measure: Client Engagement
timeFrame: Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
measure: Client - Patient Health Questionnaire - 9
timeFrame: Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
measure: Family - Patient Health Questionnaire - 9
timeFrame: Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
measure: Community Assessment of Psychic Experiences - Positive Scale 15-items Scale
timeFrame: Baseline through study completion; repeated measure to assess change through study completion, average of 6 months
Other outcomes:
measure: General Self-Efficacy Scale
timeFrame: Baseline and Month 3 of treatment period; repeated measure to assess change through study completion, an average of 3 months
measure: Social Connectedness subscale of the Youth Services Survey - Families
timeFrame: Baseline and Month 3 of treatment period; repeated measure to assess change through study completion, an average of 3 months
measure: Treatment Motivation Questionnaire
timeFrame: Baseline and Month 3 of treatment period; repeated measure to assess change through study completion, an average of 3 months
Locations:
city: Bend
country: United States
facility: Deschutes County Behavioral Health EASA
state: Oregon
city: Pasco
country: United States
facility: Comprehensive Healthcare
state: Washington
city: Tacoma
country: United States
facility: Lucid Living
state: Washington
city: Yakima
country: United States
facility: Comprehensive Healthcare
state: Washington
Study officials:
References: