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NCT Number: NCT05284721

Family Peer Navigator for Early Psychosis for 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.

Recruiting

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Key information

Conditions

Family Members Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Journeys: Coordinated Specialty care

Seattle, Washington, 98198, United States

Location status: Recruiting

Location contact

Rebecca Daughtry

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Care Coordination

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

Secondary outcomes

  1. General Self-Efficacy scale

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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

  5. 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

    Measure includes 12-items to assess therapeutic relationships.

Other outcomes

  1. Time from Referral to Enrollment to assess

    Time frame: Baseline through study completion, average of 4 months

    Provider reported measure used to assess the access to coordinated specialty care programs which a participant had as defined as the time between point of referral to receipt of mental health service.

  2. Initial Engagement to assess preliminary effectiveness

    Time frame: Baseline through study completion, average of 4 months

    Provider reported measure defined as >1 attendance or contact for the family appointment within 30 days of loved ones' intake in mental health program.

  3. Adherence to model

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

    Feasibility checklists to measure the amount and percentage of components delivered. A structured meeting log will be maintained by study staff to document solutions, barriers and challenges to implementation as well as the number of meetings scheduled and attended.

Study contacts

Contact information is provided by the study sponsor or research team.

Bryony Stokes, B.A.

CONTACT

[email protected]

509-505-7001

Oladunni Oluwoye, Ph.D.

CONTACT

[email protected]

509-368-6805

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 17, 2022
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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