Clinical High Risk for Psychosis, Ultra High Risk for Psychosis
Conditions
Keywords
psychosis, stepped-care, psychosis screening, community-based care, dissemination and implementation
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.
Detailed description
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.
Interventions
BEHAVIORALStepped-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+.
Sponsors
Sacramento County Behavioral Health Services
University of California, Davis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a dissemination and implementation trial in which the study team is training staff at nine local community mental health centers to implement a screening protocol and stepped-care intervention. These clinics will be providing treatment and the study group will be evaluating it. There is no control group.
Eligibility
Sex/Gender
ALL
Age
12 Years to 25 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: The number of youth at clinical high risk for psychosis enrolled in stepped care over the course of the intervention. | 2, 3, or 4 years depending on site | 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. |
| Acceptability: Proportion of enrolled youths who move into each step of stepped-care | 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). |
| Reach: Universal screening outcomes | 2, 3, or 4 years | 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). |
| Reach: Number of community clinicians trained in specialized stepped care | 2, 3, or 4 years | 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. |
| Effectiveness: Number of youth who meet criteria for a clinical high risk for psychosis (CHRp) syndrome at each step of the intervention. | 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
| Measure | Time frame | Description |
|---|---|---|
| Modified Colorado Symptom Index (MCSI) | Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months) | Self-report omnibus measure of symptom severity across multiple domains. |
| Barriers and Facilitators Survey | 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. |
| Global Impression Scale | Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months) | Single item self-assessment of overall life function. |
| Global Functioning: Social and Role Scales | Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months) | Clinician rated scales assessing social and role functioning. |
| Life and Treatment satisfaction | 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. |
| Barriers and Facilitators interviews | 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. |
Countries
United States
Contacts
Primary ContactDaniel I Shapiro, PhD
Backup ContactMaria Pagador
Outcome results
None listed