Family Peer Navigator for Early Psychosis for Black Families

Not Applicable

Recruiting

• Conditions: Family Members
• Interventions: Behavioral: Care Coordination; Behavioral: Family Peer Navigator for Early Psychosis

• Registration Number: NCT05284721
• Lead Sponsor: Washington State University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-03-08
• Study First Posted: 2022-03-17
• Study Start: 2023-01-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. ≥ 18 years of age
2. Identifies as Black/African American
3. Loved one who meets criteria for risk of psychosis with a total score of ≥ 3 on the Prodromal Questionnaire- Brief Version

Exclusion Criteria

1. Family members who cannot understand the consent process
2. Non-English speaking adults
3. Black/African American families referred to coordinated specialty care and who have already been determined eligible for services by providers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Care Coordination Phase III	Care Coordination	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.
Family Peer Navigator model Psychosis Phase III	Family Peer Navigator for Early Psychosis	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.

Primary Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire-8 (CSQ-8)	Months 1 through 3 of treatment period; repeated measure to assess change in acceptability through study completion, average of 4 months	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.
Rate of Retention to measure feasibility	Baseline through study completion; repeated measure to assess change in feasibility through study completion, average of 4 months	The percentage of families that drop out (family declined or missed 3 consecutive appointments).
Number of Referrals (Recruitment) to assess feasibility	Baseline through study completion; repeated measure to assess change in feasibility through study completion, average of 4 months	The number of family member participants recruited and referrals received categorized by where they originated.
Level of Engagement to measure feasibility	Baseline through study completion; repeated measure to assess change in feasibility through study completion, average of 4 months	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.
Youth Services Survey-Families (YSS-F)	Baseline and Month 3 of treatment period; repeated measure to assess change in acceptability through study completion, average of 4 months	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.

Secondary Outcome Measures

Name	Time	Method
Youth Services Survey for Families - Cultural Sensitivity Subscale	Baseline through study completion; repeated measure to assess change through study completion, average of 4 months
Youth Services Survey for Families - Social Connectedness Subscale	Baseline through study completion; repeated measure to assess change through study completion, average of 4 months	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.
Scale to Assess Therapeutic Relationships in Community Mental Health Care (STAR)	Baseline through study completion; repeated measure to assess change through study completion, average of 4 months	Measure includes 12-items to assess therapeutic relationships.
General Self-Efficacy scale	Baseline through study completion; repeated measure to assess change through study completion, average of 4 months	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.
Culturally-adapted Knowledge about Psychosis questionnaire (CaKAP)	Baseline through study completion; repeated measure to assess change through study completion, average of 4 months	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.

Trial Locations

Locations (1)

New Journeys: Coordinated Specialty care; 🇺🇸 Seattle, Washington, United States