Horyzons: Implementation and Integration in Clinical Practice (NCT06002958) | Clinical Trial Compass
TerminatedNot Applicable
Horyzons: Implementation and Integration in Clinical Practice
Stopped: Reductions in available funding
United States52 participantsStarted 2024-01-08
Plain-language summary
The primary aim of this trial is evaluating the barriers and enablers of implementing a digital intervention with both therapeutic content and social networking, Horyzons, as part of clinical care in first episode psychosis (FEP) clinics in North Carolina. Providers (clinicians and peers support specialists) will be recruited from FEP clinics to assess Horyzons implementation and integration within clinical care at three time points (baseline, 6 months, and 12 months). Further, individuals experiencing FEP between the ages of 16 and 35 receiving services from the FEP clinics will be recruited to engage with the platform over the course of 12 months. Due to the nature of the digital intervention being implemented across the state of North Carolina, all research visits will be conducted remotely via videoconferencing.
Who can participate
Age range
16 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.
CLIENT PARTICIPANTS
Inclusion Criteria:
* Clients must be between the ages of 16 and 35
* Clients must have a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or Unspecified Schizophrenia Spectrum or Other Psychotic disorder
* Clients must be receiving services at one of the five FEP clinics in North Carolina (OASIS, Encompass, Eagle, SHORE, or AEGIS) or one of their stepdown outpatient clinics (STEP and TIDES)
* Client not having any active thoughts of harming self in the month prior to enrollment
* Clients must not have been hospitalized for psychiatric reasons in the three months before enrollment
* Clients must actively be engaging with medication management through their clinic
* Clients must have access to the internet through a phone, tablet, or computer
Exclusion Criteria:
* Clients who do not speak English will not be considered for enrollment
* Adult client with legal guardians where one or both the individual and legal guardian do not provide consent for the individual to participate
PROVIDER PARTICIPANTS
Inclusion Criteria:
* Provider \&/or PSS must be 18 years or older
* Provider \&/or PSS must be currently serving clients within their FEP clinic
* Provider \&/or PSS must be able to speak and read English
Exclusion Criteria:
* Provider \&/or PSS under the age of 18
* Provider \&/or PSS not currently serving clients in their FEP clinic
* Provider \&/or PSS not able to speak or understand English
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
Qualitative Summaries of Provider and Peer Support Specialists (PSSs) Participant Feedback in Post-Treatment Interview
Timeframe: Up to 9 months
2
Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback