Family MembersNCT05284721
Family Peer Navigator for Early Psychosis for Black Families
A study testing Family Peer Navigator for Early Psychosis and Care Coordination in people with Family Members, run by Washington State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family Members
- What is being tested?
- Family Peer Navigator for Early Psychosis and Care Coordination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New Journeys: Coordinated Specialty care
Seattle, Washington, 98198
About this study
Official title: 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.
Read the 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.
- Conditions
- Family Members
- Being tested
- Family Peer Navigator for Early Psychosis, Care Coordination
- Keywords
- Black/African American, Early Psychosis, Access and Engagement
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Peer Navigator for Early PsychosisBehavioural
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
Care CoordinationBehavioural
active control, treatment as usual including services provided by the coordinated specialty care program for first-episode psychosis.
| Study group | Role | What they receive |
|---|---|---|
| Care Coordination Phase III | Active comparator | 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. Receives: Behavioral: Care Coordination |
| Family Peer Navigator model Psychosis Phase III | Experimental | 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. Receives: Behavioral: Family Peer Navigator for Early Psychosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline through study completion; repeated measure to assess change in feasibility through study completion, average of 4 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: Baseline through study completion; repeated measure to assess change through study completion, average of 4 months
Youth Services Survey for Families - Cultural Sensitivity Subscale
Measured: 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.
Measured: Baseline through study completion; repeated measure to assess change through study completion, average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Jan 2023
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Family MembersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Oladunni Oluwoye, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284721
- Sponsor's protocol ID
- 19181-001
- Status last verified
- Jul 2026
- First submitted
- 28 Feb 2022
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37407058
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Family Peer Navigator Model to Increase Access and Initial Engagement in Coordinated Specialty Care Programs Among Black Families
- ClinicalTrials.gov ID
- NCT05284721
- Acronym / sponsor ID
- 19181-001
- Conditions
- Family Members
- Keywords
- Black/African American, Early Psychosis, Access and Engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care Coordination Phase III | Active comparator | Behavioral: Care CoordinationFamily 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 | Experimental | Behavioral: Family Peer Navigator for Early PsychosisFamily 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Peer Navigator for Early PsychosisThe 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 | Behavioural | Family Peer Navigator model Psychosis Phase III |
| Care Coordinationactive control, treatment as usual including services provided by the coordinated specialty care program for first-episode psychosis. | Behavioural | Care Coordination Phase III |
Primary outcome
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.
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.
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.
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.
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).
5 secondary outcomes
General Self-Efficacy scale
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
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)
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)
Time frame: Baseline through study completion; repeated measure to assess change through study completion, average of 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Derived from this study: PubMed 37407058Oluwoye 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.
- Individual participant dataSharing planned: No
Related trials for Family Members
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
RecruitingObservational study
Clinical and Genetic Studies in Familial Non-medullary Thyroid Cancer
Non-Medullary Thyroid Cancer
RecruitingPhase 1
A Study of JNJ-87890387 for Advanced Solid Tumors
Neoplasms, Advanced Solid Tumors
RecruitingPhase 1
A Study of JNJ-89862175 for Treatment of Advanced Solid Tumors
Advanced-stage Solid Tumors
Not yet recruitingObservational study
SLAMF1 Gene Expression in Ankylosing Spondylitis
Ankylosing Spondylitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Peer Navigator for Early Psychosis and Care Coordination in people with Family Members, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05284721, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.