Family Peer Navigator for Early Psychosis for Black Families

NCT05284721 | Recruiting DMC

• 1 other identifier: 19181-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Family Members

Keywords

Black/African American; Early Psychosis; Access and Engagement

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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).

  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

  Baseline through study completion; repeated measure to assess change through study completion, average of 4 months

• Youth Services Survey for Families - Social Connectedness Subscale

  Baseline through study completion; repeated measure to assess change through study completion, average of 4 months

• Culturally-adapted Knowledge about Psychosis questionnaire (CaKAP)

  Baseline through study completion; repeated measure to assess change through study completion, average of 4 months

• Youth Services Survey for Families - Cultural Sensitivity Subscale

  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)

  Baseline through study completion; repeated measure to assess change through study completion, average of 4 months

Other Outcomes (3)

• Time from Referral to Enrollment to assess

  Baseline through study completion, average of 4 months

• Initial Engagement to assess preliminary effectiveness

  Baseline through study completion, average of 4 months

• Adherence to model

  Baseline through study completion; repeated measure to assess the implementation feasibility of services through study completion, average of 4 months

Study Arms (2)

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.

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.

Behavioral: Family Peer Navigator for Early Psychosis

Interventions

Family Peer Navigator for Early Psychosis 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

Family Peer Navigator model Psychosis Phase III

Care Coordination BEHAVIORAL

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

Care Coordination Phase III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington State University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New Journeys: Coordinated Specialty care

Seattle, Washington, 98198, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 37407058 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Oladunni Oluwoye, Ph.D.

CONTACT

509-368-6805; oladunni.oluwoye@wsu.edu

Bryony Stokes, B.A.

CONTACT

509-505-7001; bryony.mueller@wsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 17, 2022
• Study Start: January 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)