NCT04007510

California Collaborative Network to Promote Data Driven Care and Improve Outcomes in Early Psychosis

Enrolling by Invitation
NAAges 8–40InterventionalHealth services
University of California, Davis
~1,329 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:EPI-CAL data networkCommunity DUP Assessment Tool

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Enrollment
Measured over end of study, maximum of 5 years
+8 more outcomes measured
First Episode Psychosis (FEP)
1 sites across 1 states
California1

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Exclusion

neurological illness or injury leading to psychotic symptoms
reported diagnosis of intellectual disability or estimated IQ below 70 according to the Pennsylvania Computerized Neuropsychological Test Battery.
  • Enrollmentend of study, maximum of 5 years

    Show adequate reach of enrollment using descriptive statistics showing 70% of eligible FEP participants, who are representative of the target population based on current program demographics, and 50% of their available family members, across the network were enrolled and complete baseline

  • Colorado Symptom Index (CSI) - Symptom severityend of study, maximum of 5 years

    Efficacy of measurement-based care, comparing adjusted mean differences in baseline to 12-month change in psychotic symptom severity on the Colorado Symptom Index (CSI), between groups defined by clinician metrics from mHealth app assessed during this 12-month period. The CSI is a 14-item, self-report scale designed to assess frequency of positive mood and cognitive symptoms. Each item is scored on a 0-4 Likert-style scale and added together to give a score between 0 and 56, with higher scores indicating greater emotional distress. Reduction in score over time is considered clinical improvement. Maintenance of measurement-based care, based on adjusted mean differences in baseline to 24-month change in psychotic symptom severity between groups defined by clinician metrics from mHealth app aggregated over the 6-, 12- and 18-month assessment period, with the primary analysis based on a composite indicator for any endorsement of "impact on treatment plan" across these three periods.

  • Provider use of data in careend of study, maximum of 5 years

    Compared to pre-implementation period, providers will report a change in the use of data to determine treatment choices after training and using the app for 6 months (Adoption). Adoption of data in care is measure by pre- and post-surveys of randomly sampled client sessions)

  • Provider use of mHealth append of study, maximum of 5 years

    Over 12 months, EP providers will use mHealth app in direct care to FEP clients for at least 50% of completed assessments (Implementation) as measured by metrics gathered in mHealth app.

  • DUP tool reliabilityend of study, maximum of 5 years

    New DUP tool will show inter-rater reliability (IRR) between CSC providers and a MA-level assessor with an intra-class coefficient (ICC) of at least .80 for days from initial assessment to DUP start point, days from assessment to DUP end point, and days from start point to end point DUP (total DUP).

  • DUP Tool convergent validityend of study, maximum of 5 years

    New DUP tool will show convergent validity, with ICCs of at least .80 between CSC providers and centralized study team assessors using the Symptom Onset in Schizophrenia Inventory (SOS) (reference standard).

  • DUP Tool predictive validity - Functioningend of study, maximum of 5 years

    New DUP tool will show predictive validity, defined by significant relationships between shorter DUP and greater improvements in functioning (Global Social and Role Functioning scales) at 6 and 12 months - shown by regression coefficients between DUP and change from baseline to 6 and 12 months in functioning.

  • DUP Tool predictive validity - Quality of Lifeend of study, maximum of 5 years

    New DUP tool will show predictive validity, defined by significant relationships between shorter DUP and greater improvements in quality of life (Lehman Quality of Life scale) at 6 and 12 months - shown by regression coefficients between DUP and change from baseline to 6 and 12 months in quality of life.

  • DUP Tool feasibility and Acceptabilityend of study, maximum of 5 years

    Feasibility and acceptability to EP providers and clients, with a mean administration time of less than 40 minutes for the brief and full versions of the new DUP Tool