Recruiting

Stepped-Care Program

Sponsor:

UCLA

Code:

NCT06640803

Conditions

Clinical High Risk for Psychosis

Ultra High Risk for Psychosis

Eligibility Criteria

Sex: All

Age: 12 - 25

Healthy Volunteers: Not accepted

Interventions

Stepped-Care including Cognitive Behavioral Case Management

Study Details

Brief summary:

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.

Conditions

Clinical High Risk for Psychosis

Ultra High Risk for Psychosis

Study ID

NCT06640803

Start date

Mar 20, 2023

Status verified date

Dec, 2025

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Clinical High Risk for Psychosis Syndrome as assessed by the mini-SIPS
2. Aged between 12-25 years old
3. Receiving care in one of six identified community mental health clinics
4. Eligibility for Sacramento County Medicare
5. Ability to provide informed consent

Exclusion Criteria:

1. Intellectual disability (IQ\<70)
2. Urgent clinical need for a higher level of care

Study Design

Enrollment

223 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive Behavioral Case Management

Once youths are identified with a clinical high risk for psychosis (CHRp) syndrome they will begin a 2-year, 6 step intervention. They will be assessed every 6 months. If youths continue to meet CHRp criteria they will move into the next step. If they no longer meet criteria they exit the study and resume standard care. If they develop psychosis or reach the end of the 2-year intervention they can move to EDAPT, a psychosis specialty clinic or work with personnel to find a more appropriate clinical service.

Interventions

Stepped-Care including Cognitive Behavioral Case Management

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+.

Primary outcome measure

  • 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 ]
  • Acceptability: Proportion of enrolled youths who move into each step of stepped-care [ Time Frame: 2, 3, or 4 years depending on site ]
  • Reach: Universal screening outcomes [ Time Frame: 2, 3, or 4 years ]
  • Reach: Number of community clinicians trained in specialized stepped care [ Time Frame: 2, 3, or 4 years ]
  • 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 ]

Central Contacts and Locations

Central contacts

Locations

River Oak Center for Children

Recruiting

Elk Grove, California, United States, 95758

Contacts

Turning Point Community Programs

Recruiting

Elk Grove, California, United States, 95758

Contacts

Marisa Ciani, LCSW

916-427-7141

University of California Department of Psychiatry and Behavioral Sciences; Early Psychosis Programs

Recruiting

Sacramento, California, United States, 95817

Contacts

University of California-Davis CAARE Diagnostic and Treatment Center

Recruiting

Sacramento, California, United States, 95820

Contacts

Capital Star Community Services

Recruiting

Sacramento, California, United States, 95821

Contacts

Heartland Child and Family Services

Recruiting

Sacramento, California, United States, 95838

Contacts

More Information

Sponsor

University of California, Davis

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Keywords

  • psychosis
  • stepped-care
  • psychosis screening
  • community-based care
  • dissemination and implementation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2025-12-15.