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Clinical Trials/NCT05284721
NCT05284721CompletedNot Applicable

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

Washington State University3 sites in 1 country36 target enrollmentStarted: January 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
3
Primary Endpoint
Client Satisfaction Questionnaire-8 (CSQ-8)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • ≥ 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

Exclusion Criteria

  • 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.

Arms & Interventions

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.

Intervention: Care Coordination (Behavioral)

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.

Intervention: Family Peer Navigator for Early Psychosis (Behavioral)

Outcomes

Primary Outcomes

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.

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).

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.

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.

Secondary Outcomes

  • Youth Services Survey for Families - Cultural Sensitivity Subscale(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)
  • 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)
  • General Self-Efficacy scale(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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Oladunni Oluwoye

Assistant Professor

Washington State University

Study Sites (3)

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