Family Peer Navigator for Early Psychosis for Black Families

Sponsor
Washington State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05284721
Collaborator
National Institute of Mental Health (NIMH) (NIH)
50
1
2
36
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Family Peer Navigator for Early Psychosis
  • Behavioral: Care Coordination
N/A

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
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
A Family Peer Navigator Model to Increase Access and Initial Engagement in Coordinated Specialty Care Programs Among Black Families
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2025
Anticipated Study Completion Date :
Sep 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Care Coordination Phase III

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

Experimental: Family Peer Navigator model Psychosis Phase III

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
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

Outcome Measures

Primary Outcome Measures

  1. 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 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) [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 [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 [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 [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 Outcome Measures

  1. General Self-Efficacy scale [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 [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) [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 [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) [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 Outcome Measures

  1. Time from Referral to Enrollment to assess [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 [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. Feasibility of Implementation [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.

  4. Citizenship Measure to assess outer contextual factors [Baseline and Month 3 of treatment period; repeated measure through study completion, average of 4 months]

    A 46-item instrument designed to assess individuals' perceptions of their connection to and engagement with their communities.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. ≥ 18 years of age with a loved one between the ages of 15-28

  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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 New Journeys: Coordinated Specialty care Tacoma Washington United States 98409

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oladunni Oluwoye, Assistant Professor, Washington State University
ClinicalTrials.gov Identifier:
NCT05284721
Other Study ID Numbers:
  • 19181-001
First Posted:
Mar 17, 2022
Last Update Posted:
Mar 17, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Oladunni Oluwoye, Assistant Professor, Washington State University

Study Results

No Results Posted as of Mar 17, 2022