FAmily Engagement Strategy for Coordinated Specialty Care (NCT06945055) | Clinical Trial Compass
RecruitingNot Applicable
FAmily Engagement Strategy for Coordinated Specialty Care
United States900 participantsStarted 2025-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Engagement in coordinated specialty care psychoeducation
Timeframe: Baseline through study completion; repeated measure to assess change through study completion, average of 3 months
2
Engagement in Family Engagement Strategy
Timeframe: Baseline through study completion; repeated measure to assess change through study completion, average of 3 months