Optimizing Engagement in Services for First-Episode Psychosis (NCT05310838) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Optimizing Engagement in Services for First-Episode Psychosis
United States58 participantsStarted 2022-03-01
Plain-language summary
This study will compare a 12-session behavioral activation (BA) intervention modified for first-episode psychosis (FEP) to usual community mental health care (i.e., treatment-as-usual; TAU) delivered over 6 months with a sample of Latinos with FEP and their families. Comparable family group sessions will also be delivered to participants in both conditions. It is expected that BA participants will show better engagement than TAU participants.
Who can participate
Age range
15 Years – 35 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.
Inclusion Criteria:
* Self-identification as Latino
* Age 15 to 35
* Diagnostic \& Statistical Manual of Mental Disorders-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, other specified schizophrenia spectrum, affective psychosis, and other psychotic disorder criteria
* Ability to speak English or Spanish
* Caregiver willing to consent to participate in the study and care
* Ability to provide fully informed consent
Exclusion Criteria:
* Diagnosis of psychotic disorder due to another medical condition or substance/medication-induced psychotic disorder
* Presence of a serious medical condition
* 3≤ years after the onset
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
Change in Engagement on the Patient Activation Measure (PAM13) at Post-Intervention
Timeframe: Change from Pre-intervention PAM13 at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
2
Change in Engagement on the Patient Activation Measure (PAM13) at 1-Month Post-Intervention
Timeframe: Change from Pre-intervention PAM13 at 1-month-post-intervention
3
Change in Engagement on the Patient Activation Measure (PAM13) at 6-Months Post-Intervention
Timeframe: Change from Pre-intervention PAM13 at 6-months-post-intervention
4
Engagement as measured by the Service Engagement Scale (SES)
Timeframe: Weekly per session up to 12 sessions, up to 6 months
Trial details
NCT IDNCT05310838
SponsorCalifornia State University, San Bernardino