Family Peer Navigator for Early Psychosis for Black Families
ConditionFamily Members
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington State University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥ 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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Family Peer Navigator for Early Psychosis
BehavioralThe 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
Behavioralactive control, treatment as usual including services provided by the coordinated specialty care program for first-episode psychosis.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Care Coordination Phase IIIActive comparator 1 intervention
Group B: Family Peer Navigator model Psychosis Phase IIIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Months 1 through 3 of treatment period; repeated measure to assess change in acceptability through study completion, average of 4 months2
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.
Time frame
Baseline and Month 3 of treatment period; repeated measure to assess change in acceptability through study completion, average of 4 months3
Number of Referrals (Recruitment) to assess feasibility
The number of family member participants recruited and referrals received categorized by where they originated.
Time frame
Baseline through study completion; repeated measure to assess change in feasibility through study completion, average of 4 months4
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.
Time frame
Baseline through study completion; repeated measure to assess change in feasibility through study completion, average of 4 monthsSecondary outcomes
1
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.
Time frame
Baseline through study completion; repeated measure to assess change through study completion, average of 4 months2
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.
Time frame
Baseline through study completion; repeated measure to assess change through study completion, average of 4 months3
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.
Time frame
Baseline through study completion; repeated measure to assess change through study completion, average of 4 months4
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 monthsOther outcomes
1
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.
Time frame
Baseline through study completion, average of 4 months2
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.
Time frame
Baseline through study completion, average of 4 months3
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.
Time frame
Baseline through study completion; repeated measure to assess the implementation feasibility of services through study completion, average of 4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington State University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov