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Family Peer Navigator for Early Psychosis for Black Families

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05284721
Enrollment
36
Registered
2022-03-17
Start date
2023-01-01
Completion date
2026-04-30
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Family Members

Keywords

Black/African American, Early Psychosis, Access and Engagement

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.

Interventions

BEHAVIORALFamily 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

BEHAVIORALCare Coordination

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

Sponsors

Washington State University
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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 monthsSelf-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)Baseline and Month 3 of treatment period; repeated measure to assess change in acceptability through study completion, average of 4 monthsSelf-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 feasibilityBaseline through study completion; repeated measure to assess change in feasibility through study completion, average of 4 monthsThe number of family member participants recruited and referrals received categorized by where they originated.
Level of Engagement to measure feasibilityBaseline through study completion; repeated measure to assess change in feasibility through study completion, average of 4 monthsTotal 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 feasibilityBaseline through study completion; repeated measure to assess change in feasibility through study completion, average of 4 monthsThe percentage of families that drop out (family declined or missed 3 consecutive appointments).

Secondary

MeasureTime frameDescription
General Self-Efficacy scaleBaseline through study completion; repeated measure to assess change through study completion, average of 4 monthsA 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.
Youth Services Survey for Families - Social Connectedness SubscaleBaseline through study completion; repeated measure to assess change through study completion, average of 4 monthsSocial 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.
Culturally-adapted Knowledge about Psychosis questionnaire (CaKAP)Baseline through study completion; repeated measure to assess change through study completion, average of 4 monthsSelf-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.
Youth Services Survey for Families - Cultural Sensitivity SubscaleBaseline 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)Baseline through study completion; repeated measure to assess change through study completion, average of 4 monthsMeasure includes 12-items to assess therapeutic relationships.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026