Family Peer Navigator for Early Psychosis for Black Families

NCT ID: NCT05284721

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Family Members

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Care Coordination

Intervention Type BEHAVIORAL

active control, treatment as usual including services provided by the coordinated specialty care program for first-episode psychosis.

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.

Group Type EXPERIMENTAL

Family Peer Navigator for Early Psychosis

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Care Coordination

active control, treatment as usual including services provided by the coordinated specialty care program for first-episode psychosis.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Washington State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Oladunni Oluwoye

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

New Journeys: Coordinated Specialty care

Seattle, Washington, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Oladunni Oluwoye, Ph.D.

Role: CONTACT

509-368-6805

Bryony Stokes, B.A.

Role: CONTACT

509-505-7001

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Rebecca Daughtry

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Oluwoye O, Stokes BI, Burduli E, Kriegel LS, Hoagwood KE. Community-based family peer navigator programme to facilitate linkage to coordinated specialty care for early psychosis among Black families in the USA: A protocol for a hybrid type I feasibility study. BMJ Open. 2023 Jul 5;13(7):e075729. doi: 10.1136/bmjopen-2023-075729.

Reference Type DERIVED
PMID: 37407058 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

19181-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Trial to Increase FEP Attendance
NCT05967195 ACTIVE_NOT_RECRUITING EARLY_PHASE1
mHealth for Psychosis Help-seeking
NCT05905601 COMPLETED NA