An interventional study of Family Peer Navigator for Early Psychosis and Care Coordination in Family Members, sponsored by Washington State University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Washington State University · Not applicable, Interventional, and Health services research
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.
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.
1,626 studies on the registry are indexed under Psychotic Disorders; 293 are open to participants now.
This study's enrollment of 36 is below the median of 70 across 1,333 interventional studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →Washington State University is the lead sponsor of 82 studies on the registry; 16 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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Exclusion Criteria:
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
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
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
active control, treatment as usual including services provided by the coordinated specialty care program for first-episode psychosis.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline through study completion; repeated measure to assess change in feasibility through study completion, average of 4 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline through study completion; repeated measure to assess change through study completion, average of 4 months
Youth Services Survey for Families - Cultural Sensitivity Subscale
Time frame: 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.
Time frame: Baseline through study completion; repeated measure to assess change through study completion, average of 4 months
Time from Referral to Enrollment to assess
Provider reported measure used to assess the access to coordinated specialty care programs which a participant had as defined as the time between point of referral to receipt of mental health service.
Time frame: Baseline through study completion, average of 4 months
Initial Engagement to assess preliminary effectiveness
Provider reported measure defined as \>1 attendance or contact for the family appointment within 30 days of loved ones' intake in mental health program.
Time frame: Baseline through study completion, average of 4 months
Adherence to model
Feasibility checklists to measure the amount and percentage of components delivered. A structured meeting log will be maintained by study staff to document solutions, barriers and challenges to implementation as well as the number of meetings scheduled and attended.
Time frame: Baseline through study completion; repeated measure to assess the implementation feasibility of services through study completion, average of 4 months
Plan to share: No
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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