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Sacramento Clinical High Risk for Psychosis Stepped-Care Program

ConditionsClinical High Risk for PsychosisUltra High Risk for Psychosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-25
SponsorUniversity of California, Davis

About this trial

This is a dissemination and implementation study that is evaluating a stepped-care intervention for identifying and treating youths at clinical high-risk for psychosis within multiple community mental health centers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical High Risk for Psychosis Syndrome as assessed by the mini-SIPS

Aged between 12-25 years old

Receiving care in one of six identified community mental health clinics

Eligibility for Sacramento County Medicare

Disqualifiers

Intellectual disability (IQ<70)

Urgent clinical need for a higher level of care

Trial design

Design model

Single group

Treatments tested in this trial

  • Stepped-Care including Cognitive Behavioral Case Management

    Behavioral

    Step 1:assessment and feedback, general engagement strategies, assessment of needs and social determinants of health, begin case management, goal setting. Step 2: TAU. Initiation of team-based care at community clinics and 'enhanced monitoring'. Step 3: atheoretically-based stress management skills (stress thermometer, coping skills and coping plans), problem solving strategies. Step 4: targeted intervention for CHRp. Initiation of formulation-based CBT modules, therapy consultation groups with the UC Davis team (UCD), regular meetings between clinic leadership and UCD. Participants may switch providers to increase level of early psychosis specialization. Step 5: add prescriber consultation groups with UCD. Step 6: assessment of trauma and family conflict then Family-Focused Therapy, Trauma-Focused Cognitive Behavioral Therapy, or CBT for CHR at UCD. Termination: At 24 months, referral to UCD coordinated specialty care clinic or other appropriate service for those still CHRp+.

Treatment groups

223 Participants
are divided into 1 treatment group
Group A: Cognitive Behavioral Case ManagementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility: The number of youth at clinical high risk for psychosis enrolled in stepped care over the course of the intervention.

1\. Duration of enrollment in the stepped-care intervention for young people identified as at clinical high-risk for psychosis through their community health setting.

Time frame
2, 3, or 4 years depending on site
2

Acceptability: Proportion of enrolled youths who move into each step of stepped-care

Number of youth enrolled in stepped care at each assessment time point (0-, 6-, 12-, 18-, 24-month).

Time frame
2, 3, or 4 years depending on site
3

Reach: Universal screening outcomes

Number of youths who reach each stage of the screening pipeline including: 1. Number of youths screened. 2. Number of screened youths who score positive on the screening measure (Prodromal Questionnaire Brief).

Time frame
2, 3, or 4 years
4

Reach: Number of community clinicians trained in specialized stepped care

1. The number of clinicians employed at targeted community mental health agencies who complete training in Cognitive Behavioral Case management (CBCM). 2. The number of these CBCM trained clinicians who enroll in the trial.

Time frame
2, 3, or 4 years

Secondary outcomes

1

Modified Colorado Symptom Index (MCSI)

Self-report omnibus measure of symptom severity across multiple domains.

Time frame
Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
2

Global Impression Scale

Single item self-assessment of overall life function.

Time frame
Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
3

Global Functioning: Social and Role Scales

Clinician rated scales assessing social and role functioning.

Time frame
Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
4

Life and Treatment satisfaction

Self-report likert scale questions that assess overall functioning, symptom severity, and satisfaction with various aspects of the trial treatment.

Time frame
Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

Sacramento County Behavioral Health Services

Collaborator

Source ClinicalTrials.gov
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