Study Summary
This trial will test a new strategy, called FAMES, to help families support their loved ones with psychosis in coordination with specialized care programs.
Eligible Conditions
- Family
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 5 Secondary · Reporting Duration: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Year 1
Burden Assessment Scale (BAS)
Client Satisfaction Questionnaire-8 (CSQ-8)
Iowa Cultural Understanding Assessment
Level of Engagement to measure effectiveness of FAMES
Organizational Readiness to Change Assessment (ORCA)
Rate of Retention to measure effectiveness of FAMES
Treatment Self-Regulation Questionnaire (TSRQ)
Youth Services Survey-Families (YSS-F)
Month 1
Qualitative interviews
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
FAMES Pilot Trial
1 of 2
FAMES Modification
1 of 2
Experimental Treatment
55 Total Participants · 2 Treatment Groups
Primary Treatment: FAMES · No Placebo Group · N/A
FAMES Pilot TrialExperimental Group · 2 Interventions: FAMES, Treatment-as-Usual · Intervention Types: Behavioral, Behavioral
FAMES Modification
Behavioral
Experimental Group · 1 Intervention: FAMES · Intervention Types: BehavioralTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment-as-Usual
2017
N/A
~80
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through study completion, an average of 1 year; repeated measure to assess change through study completion
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,552 Previous Clinical Trials
1,823,442 Total Patients Enrolled
1 Trials studying Family
220 Patients Enrolled for Family
Washington State UniversityLead Sponsor
84 Previous Clinical Trials
55,087 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Oluwoye, Oladunni, Dennis Dyck, Sterling M McPherson, Roberto Lewis-Fernández, Michael T Compton, Michael G McDonell, and Leopoldo J Cabassa. 2020. “Developing and Implementing a Culturally Informed family motivational engagement strategy (FAMES) to Increase Family Engagement in First Episode Psychosis Programs: Mixed Methods Pilot Study Protocol”. BMJ Open. BMJ. doi:10.1136/bmjopen-2020-036907.
- Oluwoye O, Dyck D, McPherson SM, Lewis-Fernandez R, Compton MT, McDonell MG, Cabassa LJ. Developing and implementing a culturally informed FAmily Motivational Engagement Strategy (FAMES) to increase family engagement in first episode psychosis programs: mixed methods pilot study protocol. BMJ Open. 2020 Aug 26;10(8):e036907. doi: 10.1136/bmjopen-2020-036907.
- Oladunni Oluwoye 2021. "Improving Family Engagement in Coordinated Specialty Care for First Episode Psychosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04188366.
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Conditions
Cancer Related
Treatments