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临床试验/NCT04188366
NCT04188366已完成不适用

Improving Family Engagement in First Episode Psychosis Care

Washington State University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Client Satisfaction Questionnaire-8 (CSQ-8)

研究概览

简要总结

Investigators aim to develop and evaluate a culturally informed family motivational engagement strategy (FAMES) and implementation toolkit for coordinated specialty care (CSC) programs for first episode psychosis. First, 5 family member participants will be recruited into a three-month trial of FAMES and implementation toolkit. The investigators will then conduct a 16-month non-randomized, stepped-wedge trial with 50 family members from 5 CSC programs in community-based mental health clinics.

详细描述

FAMES involves three distinct and revolving components - early, continuous, and motivational contact - that incorporate motivational techniques and the Diagnostic and Statistical Manual of Mental Disorders 5TH Edition (DSM-5) Cultural Formulation Interview (CFI).

The overarching objective of this study is to assess the feasibility and acceptability of a brief provider-led FAmily Engagement Motivational Strategy (FAMES) and its accompanying implementation toolkit. The investigators will also preliminary examine whether FAMES improves family engagement and retention in treatment, and motivation.

A total of 50 participants with a loved one enrolled in CSC program for FEP will be recruited from five CSC programs in Washington State to take part in a non-randomized stepped-wedge pilot trial. Each CSC program will represent a cluster and serve as its own control. A two-month implementation transition period will occur at each CSC program and during which providers will be introduced to the intervention using the implementation toolkits and trained to conduct FAMES. A 12-month open cohort design will be utilized to recruit approximately 50 family members during the study period.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
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

  • Aged 18 years or older;
  • One family member (e.g., parent, guardian, aunt, uncle, spouse, grandparent, sibling, close friend) of an individual enrolled in a Washington State CSC program; and
  • Received no more than 6 months of services

排除标准

  • 未提供

结局指标

主要结局

Client Satisfaction Questionnaire-8 (CSQ-8)

时间窗: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion

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.

Youth Services Survey-Families (YSS-F)

时间窗: Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion

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.

Qualitative interviews

时间窗: Month 1 of treatment period and month 1 follow-up period; repeated measure to assess change in acceptability and feasibility

Interviews with providers and family member participants to assess acceptability and of FAMES

次要结局

  • Rate of Retention to measure effectiveness of FAMES(Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion)
  • Level of Engagement to measure effectiveness of FAMES(Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion)
  • Burden Assessment Scale (BAS)(Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion)
  • Iowa Cultural Understanding Assessment(Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion)
  • Treatment Self-Regulation Questionnaire (TSRQ)(Baseline through study completion, an average of 1 year; repeated measure to assess change through study completion)

研究者

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

Oladunni Oluwoye

Research Assistant Professor

Washington State University

研究点 (2)

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