Family Peer Navigator for Early Psychosis for Black Families

Study Overview
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Brief Summary
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Building upon formative research, this mixed methods study will be conducted in three phases to develop, refine, and pilot-test a multi-component Family Peer Navigator model designed to increase access to and initial engagement in coordinated specialty care for early psychosis among Black/African American families.

Detailed Description
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The overall goal of this mixed methods study will be conducted in three phases to develop, refine, and pilot-test a multi-component Family Peer Navigator model designed to increase access to and engagement in coordinated specialty care programs among Black/African American families. Phase II will recruit 10 family member participants to complete a four-month open trial to refine the Family Peer Navigator model. During Phase III, a total of 40 Black/African American families will be recruited to participate in a randomized pilot trial of the Family Peer Navigator model against a low-intensive care coordination in two coordinated specialty care programs to assess acceptability, feasibility, and preliminary impact.

Official Title
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A Family Peer Navigator Model to Increase Access and Initial Engagement in Coordinated Specialty Care Programs Among Black Families

Conditions
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Family Members

Intervention / Treatment
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* Behavioral: Family Peer Navigator for Early Psychosis
* Behavioral: Care Coordination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age Identifies as Black/African American Loved one who meets criteria for risk of psychosis with a total score of ≥ 3 on the Prodromal Questionnaire- Brief Version Exclusion Criteria: Family members who cannot understand the consent process Non-English speaking adults Black/African American families referred to coordinated specialty care and who have already been determined eligible for services by providers.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Care Coordination Phase III<br>Family member participants randomized to the active control will receive two brief psychoeducation sessions, two brief check ins across one month and linked to appropriate services. | Behavioral: Care Coordination<br>* active control, treatment as usual including services provided by the coordinated specialty care program for first-episode psychosis.<br>|
| Experimental: Family Peer Navigator model Psychosis Phase III<br>Family member participants randomized to the Family Peer Navigator condition will participate in two sessions for introduction/assessment, four individual psychoeducation sessions, and six brief check ins delivered by Family Peer Navigators. | Behavioral: Family Peer Navigator for Early Psychosis<br>* The Family Peer Navigator model is theoretical underpinning by the Social-Ecological Model and the Social Cognitive Theory, that incorporates a mixture of evidence- and research-based strategies, to include three key components: 1) Introduction and Assessment; 2) Individual Psychoeducation; 3) Six Brief Check-In<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Client Satisfaction Questionnaire-8 (CSQ-8) | Self-report measure to assess acceptability, a brief measure for family member participant. Items are scored from 1 to 4. Possible total scores range from 8 to 32, with higher scores (>23) indicating greater satisfaction. | Months 1 through 3 of treatment period; repeated measure to assess change in acceptability through study completion, average of 4 months | 
| Youth Services Survey-Families (YSS-F) | Self-report measure to assess acceptability in the following domains: appropriateness, participation, cultural sensitivity, social connectedness, and outcomes. Items in a domain are summed and divided by the total number of items, and scores greater than 3.5 are reported in the positive range for the domain. | Baseline and Month 3 of treatment period; repeated measure to assess change in acceptability through study completion, average of 4 months | 
| Number of Referrals (Recruitment) to assess feasibility | The number of family member participants recruited and referrals received categorized by where they originated. | Baseline through study completion; repeated measure to assess change in feasibility through study completion, average of 4 months | 
| Level of Engagement to measure feasibility | Total number of sessions attended, the number of contact hours with families and by which method (videoconference, in person, text, email etc.) and the number of completed measures. | Baseline through study completion; repeated measure to assess change in feasibility through study completion, average of 4 months | 
| Rate of Retention to measure feasibility | The percentage of families that drop out (family declined or missed 3 consecutive appointments). | Baseline through study completion; repeated measure to assess change in feasibility through study completion, average of 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Self-Efficacy scale | A self report measure of self-efficacy correlated to emotion, optimism and work satisfaction. Scores range from 10 to 40 with higher scores indicating more self-efficacy. | Baseline through study completion; repeated measure to assess change through study completion, average of 4 months | 
| Youth Services Survey for Families - Social Connectedness Subscale | Social connectedness will be measured using four questions (e.g., I know people who will listen and understand me when I need to talk) from the YSS-F. Scores range from 4 to 20, higher scores indicating greater social connectedness. | Baseline through study completion; repeated measure to assess change through study completion, average of 4 months | 
| Culturally-adapted Knowledge about Psychosis questionnaire (CaKAP) | Self-reported measure that includes 23 culturally specific items across five subscales: symptoms and problems relating to psychosis; cause; other treatments and services; course and outcome; and management. Total scores range from 0 through 104 where higher scores indicate greater knowledge. | Baseline through study completion; repeated measure to assess change through study completion, average of 4 months | 
| Youth Services Survey for Families - Cultural Sensitivity Subscale |  | Baseline through study completion; repeated measure to assess change through study completion, average of 4 months | 
| Scale to Assess Therapeutic Relationships in Community Mental Health Care (STAR) | Measure includes 12-items to assess therapeutic relationships. | Baseline through study completion; repeated measure to assess change through study completion, average of 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Black/African American, Early Psychosis, Access and Engagement