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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
223
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+.
River Oak Center for Children
Elk Grove, California, United States
RECRUITINGTurning Point Community Programs
Elk Grove, California, United States
RECRUITINGUniversity of California Department of Psychiatry and Behavioral Sciences; Early Psychosis Programs
Sacramento, California, United States
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
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
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
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
Effectiveness: Number of youth who meet criteria for a clinical high risk for psychosis (CHRp) syndrome at each step of the intervention.
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).
Time frame: from enrollment to the end of treatment at 2 years
Modified Colorado Symptom Index (MCSI)
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University of California-Davis CAARE Diagnostic and Treatment Center
Sacramento, California, United States
RECRUITINGCapital Star Community Services
Sacramento, California, United States
RECRUITINGHeartland Child and Family Services
Sacramento, California, United States
RECRUITINGSelf-report omnibus measure of symptom severity across multiple domains.
Time frame: Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
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)
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)
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)
Barriers and Facilitators interviews
Qualitative interviews with study clinicians and site leadership to identify barriers and facilitators to implementation.
Time frame: 6 months after enrollment and when their final treatment client completes treatment
Barriers and Facilitators Survey
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.
Time frame: 6 months after clinician's enrollment and again when their final client completes care