Clinical trial NCT05284721: Family Peer Navigator for Early Psychosis for Black Families
Official title: A Family Peer Navigator Model to Increase Access and Initial Engagement in Coordinated Specialty Care Programs Among Black Families
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Family Members
Keywords: Black/African American
Early Psychosis
Access and Engagement
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-03-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: Months 1 through 3 of treatment period; repeated measure to assess change in acceptability through study completion, average of 4 months
measure: Youth Services Survey-Families (YSS-F)
timeFrame: Baseline and Month 3 of treatment period; repeated measure to assess change in acceptability through study completion, average of 4 months
measure: Number of Referrals (Recruitment) to assess feasibility
timeFrame: Baseline through study completion; repeated measure to assess change in feasibility through study completion, average of 4 months
measure: Level of Engagement to measure feasibility
timeFrame: Baseline through study completion; repeated measure to assess change in feasibility through study completion, average of 4 months
measure: Rate of Retention to measure feasibility
timeFrame: Baseline through study completion; repeated measure to assess change in feasibility through study completion, average of 4 months
Secondary outcomes:
measure: General Self-Efficacy scale
timeFrame: Baseline through study completion; repeated measure to assess change through study completion, average of 4 months
measure: Youth Services Survey for Families - Social Connectedness Subscale
timeFrame: Baseline through study completion; repeated measure to assess change through study completion, average of 4 months
measure: Culturally-adapted Knowledge about Psychosis questionnaire (CaKAP)
timeFrame: Baseline through study completion; repeated measure to assess change through study completion, average of 4 months
measure: Youth Services Survey for Families - Cultural Sensitivity Subscale
timeFrame: Baseline through study completion; repeated measure to assess change through study completion, average of 4 months
measure: Scale to Assess Therapeutic Relationships in Community Mental Health Care (STAR)
timeFrame: Baseline through study completion; repeated measure to assess change through study completion, average of 4 months
Other outcomes:
measure: Time from Referral to Enrollment to assess
timeFrame: Baseline through study completion, average of 4 months
measure: Initial Engagement to assess preliminary effectiveness
timeFrame: Baseline through study completion, average of 4 months
measure: Adherence to model
timeFrame: Baseline through study completion; repeated measure to assess the implementation feasibility of services through study completion, average of 4 months
Locations:
city: Seattle
country: United States
facility: New Journeys: Coordinated Specialty care
state: Washington
Study officials:
References: