Family Peer Navigator for Early Psychosis for Black Families

Family Members Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05284721
• Other study ID #: 19181-001
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2023
• Source: Washington State University
• Contact: Oladunni Oluwoye, Ph.D.
• Phone: 509-368-6805
• Email: oladunni.oluwoye[@]wsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Family Members

Intervention

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

Locations

Country	Name	City	State
United States	New Journeys: Coordinated Specialty care	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Washington State University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time from Referral to Enrollment to assess	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.	Baseline through study completion, average of 4 months
Other	Initial Engagement to assess preliminary effectiveness	Provider reported measure defined as >1 attendance or contact for the family appointment within 30 days of loved ones' intake in mental health program.	Baseline through study completion, average of 4 months
Other	Adherence to model	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.	Baseline through study completion; repeated measure to assess the implementation feasibility of services through study completion, average of 4 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	General Self-Efficacy scale	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.	Baseline through study completion; repeated measure to assess change through study completion, average of 4 months
Secondary	Youth Services Survey for Families - Social Connectedness Subscale	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.	Baseline through study completion; repeated measure to assess change through study completion, average of 4 months
Secondary	Culturally-adapted Knowledge about Psychosis questionnaire (CaKAP)	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.	Baseline through study completion; repeated measure to assess change through study completion, average of 4 months
Secondary	Youth Services Survey for Families - Cultural Sensitivity Subscale		Baseline through study completion; repeated measure to assess change through study completion, average of 4 months
Secondary	Scale to Assess Therapeutic Relationships in Community Mental Health Care (STAR)	Measure includes 12-items to assess therapeutic relationships.	Baseline through study completion; repeated measure to assess change through study completion, average of 4 months