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临床试验/NCT05284721
NCT05284721已完成不适用

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

Washington State University3 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
3
主要终点
Client Satisfaction Questionnaire-8 (CSQ-8)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 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

排除标准

  • 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.

研究组 & 干预措施

Care Coordination Phase III

Active Comparator

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.

干预措施: Care Coordination (Behavioral)

Family Peer Navigator model Psychosis Phase III

Experimental

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.

干预措施: Family Peer Navigator for Early Psychosis (Behavioral)

结局指标

主要结局

Client Satisfaction Questionnaire-8 (CSQ-8)

时间窗: 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.

Rate of Retention to measure feasibility

时间窗: 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).

Number of Referrals (Recruitment) to assess feasibility

时间窗: 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.

Level of Engagement to measure feasibility

时间窗: 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.

Youth Services Survey-Families (YSS-F)

时间窗: 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.

次要结局

  • Youth Services Survey for Families - Cultural Sensitivity Subscale(Baseline through study completion; repeated measure to assess change through study completion, average of 4 months)
  • Youth Services Survey for Families - Social Connectedness Subscale(Baseline through study completion; repeated measure to assess change through study completion, average of 4 months)
  • 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)
  • General Self-Efficacy scale(Baseline through study completion; repeated measure to assess change through study completion, average of 4 months)
  • Culturally-adapted Knowledge about Psychosis questionnaire (CaKAP)(Baseline through study completion; repeated measure to assess change through study completion, average of 4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Oladunni Oluwoye

Assistant Professor

Washington State University

研究点 (3)

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