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NCT Number: NCT06640803

Sacramento Clinical High Risk for Psychosis Stepped-Care Program

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.

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Key information

Conditions

Clinical High Risk for Psychosis Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Ultra High Risk for Psychosis

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

River Oak Center for Children, Elk Grove, California, United States

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About this study

The study aims to increase the capacity to identify and treat youths at clinical high-risk for psychosis (CHRp) across Sacramento, CA by disseminating and implementing in community mental health clinics (CMHCs) universal screening and a stepped-care, team-based intervention that includes training and ongoing support in a Cognitive Behavioral Therapy package called Cognitive Behavioral Case Management (CBCM). The study is being conducted in nine non-psychosis specialty CMHCs across 5 agencies, all of which treat young people with public insurance (Medi-Cal/Medicaid) or no insurance. All youths aged 12-25 will be screened when beginning care and those who screen positive and agree will be assessed by the only specialty early psychosis clinic in the county, at the University of California-Davis. Thus the study also aims to triage this limited resource of specialized early psychosis expertise. CHRp+ youth will then begin a 2 year stepped-care intervention at their CMHCs and can move to the early psychosis specialty clinic if they still meet CHRp criteria after 2 years or develop psychosis. The specialty early psychosis service provides ongoing support and consultation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Ability to provide informed consent

Exclusion criteria

  • Intellectual disability (IQ<70)
  • Urgent clinical need for a higher level of care

Treatment and study plan

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+.

Other names: Cognitive Behavioral Therapy for those at clinical high risk for psychosis, team-based stepped-care

Primary outcomes

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

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

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

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

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

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

  3. Reach: Universal screening outcomes

    Time frame: 2, 3, or 4 years

    Number of youths who reach each stage of the screening pipeline including:

    • Number of youths screened.
    • Number of screened youths who score positive on the screening measure (Prodromal Questionnaire Brief).

  4. Reach: Number of community clinicians trained in specialized stepped care

    Time frame: 2, 3, or 4 years

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

  5. Effectiveness: Number of youth who meet criteria for a clinical high risk for psychosis (CHRp) syndrome at each step of the intervention.

    Time frame: from enrollment to the end of treatment at 2 years

    Number of youth who meet CHRp criteria on the Abbreviated Clinical Structured Interview for DSM-5 Attenuated Psychosis Syndrome (mini SIPS) and reach each stage of the intervention (baseline, 6-, 12-, 18-, 24-months).

Secondary outcomes

  1. Modified Colorado Symptom Index (MCSI)

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

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

  2. Global Impression Scale

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

    Single item self-assessment of overall life function.

  3. Global Functioning: Social and Role Scales

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

    Clinician rated scales assessing social and role functioning.

  4. Life and Treatment satisfaction

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

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

  5. Barriers and Facilitators interviews

    Time frame: 6 months after enrollment and when their final treatment client completes treatment

    Qualitative interviews with study clinicians and site leadership to identify barriers and facilitators to implementation.

  6. Barriers and Facilitators Survey

    Time frame: 6 months after clinician's enrollment and again when their final client completes care

    Survey created by study investigators to accompany qualitative interviews and assess opinions on the appropriateness and effectiveness of Cognitive Behavioral Case Management and stepped-care in this setting.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel I Shapiro, PhD

CONTACT

[email protected]

916-734-7875

Maria Pagador

CONTACT

[email protected]

916-799-4932

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Sacramento County Behavioral Health Services

Registry information

Official study title

Increasing Access to Evidence-Based CHR-P Assessment and Treatment Via Stepped-Care in Community-based Settings

Acronym: SCIP Step

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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