Family Peer Navigator for Early Psychosis for Black Families

July 30, 2026 updated by: Oladunni Oluwoye, Washington State University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98198
        • New Journeys: Coordinated Specialty care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Care Coordination Phase III
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
active control, treatment as usual including services provided by the coordinated specialty care program for first-episode psychosis.
Experimental: Family Peer Navigator model Psychosis Phase III
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Client Satisfaction Questionnaire-8 (CSQ-8)
Time Frame: 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.
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)
Time Frame: 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.
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
Time Frame: 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.
Baseline through study completion; repeated measure to assess change in feasibility through study completion, average of 4 months
Level of Engagement to measure feasibility
Time Frame: 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.
Baseline through study completion; repeated measure to assess change in feasibility through study completion, average of 4 months
Rate of Retention to measure feasibility
Time Frame: 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).
Baseline through study completion; repeated measure to assess change in feasibility through study completion, average of 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
General Self-Efficacy scale
Time Frame: 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.
Baseline through study completion; repeated measure to assess change through study completion, average of 4 months
Youth Services Survey for Families - Social Connectedness Subscale
Time Frame: 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.
Baseline through study completion; repeated measure to assess change through study completion, average of 4 months
Culturally-adapted Knowledge about Psychosis questionnaire (CaKAP)
Time Frame: 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.
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
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)
Time Frame: Baseline through study completion; repeated measure to assess change through study completion, average of 4 months
Measure includes 12-items to assess therapeutic relationships.
Baseline through study completion; repeated measure to assess change through study completion, average of 4 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time from Referral to Enrollment to assess
Time Frame: Baseline through study completion, average of 4 months
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.
Baseline through study completion, average of 4 months
Initial Engagement to assess preliminary effectiveness
Time Frame: Baseline through study completion, average of 4 months
Provider reported measure defined as >1 attendance or contact for the family appointment within 30 days of loved ones' intake in mental health program.
Baseline through study completion, average of 4 months
Adherence to model
Time Frame: Baseline through study completion; repeated measure to assess the implementation feasibility of services through study completion, average of 4 months
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.
Baseline through study completion; repeated measure to assess the implementation feasibility of services through study completion, average of 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19181-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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