跳至主要内容
临床试验/NCT06945055
NCT06945055招募中不适用

Integration of a Culturally Responsive Family Peer Delivered Engagement Strategy in Coordinated Specialty Care

Washington State University4 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2025年3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
招募中
入组人数
900
试验地点
4
主要终点
Engagement in coordinated specialty care psychoeducation

研究概览

简要总结

Family members/support persons' engagement in mental health services has been linked to reduced burden and stress and improves engagement and outcomes in individuals in the early stages of psychosis. The goal of FAMES is to address low family member/support person engagement in services. FAMES will also address disparities in coordinated specialty care (CSC) by using a culturally responsive family engagement strategy to be delivered by family peers.

详细描述

The overall goal of this mixed-methods, clustered stepped-wedged designed study is to examine the effectiveness of a family peer implemented in coordinated specialty care programs at engaging family members in services. The use of a family peer is anticipated to increase family member participant's feelings of connectedness, self-efficacy, and motivation which will in turn improve family member participants engagement in scheduled coordinated specialty care services such as family psychoeducation.

Recruitment will consist of dyads compromised of a family member support person and a corresponding individual receiving coordinated specialty care services. Recruitment will occur over two waves, the attention control condition (ACC) and the FAMES condition. The ACC will last for 18 months and will recruit 225 participant dyads during which time family member participants will be contacted weekly for 12 weeks where they will be provided with positively framed messaging, educational materials around psychosis, tips for addressing relevant concerns in areas such as communication and de-escalation, and a list of community-based and online resources and events. The FAMES condition will last for 30 months and will recruit 225 participant dyads during which time family member participants will receive a modified cultural formulation interview, brief check-ins, psychoeducation, and will have access to an online community.

Recruitment will take place at nine coordinated specialty care programs across four states (Washington, Oregon, Tennessee, and New Mexico) which have been randomized to a clustered stepped wedge program design.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
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
否

入选标准

  • •Family Member / Support Person Inclusion Criteria:
  • •Family member/support person of an individual enrolled in coordinated specialty care services for less than or equal to 6 months.
  • •18 years of age or older.
  • •During the active implementation period (FAMES) did not participate in the attention control condition.

排除标准

  • •If they do not understand the consent process.
  • •If they do not speak and/or understand English or Spanish.
  • •Primary Service User Inclusion Criteria
  • •enrolled in coordinated specialty care services for less than or equal to 6 months.
  • •15 years of age or older.
  • •Has a family member/support person willing to engage in the study. during the active implementation period (FAMES) did not participate in the attention control condition.
  • •Exclusion Criteria
  • •if they do not understand the consent process
  • •If they do not speak and/or understand English or Spanish

研究组 & 干预措施

Active Condition

Active Comparator

This arm lasts for 30 months during each wave of the clustered randomized stepped wedge design. 225 participants will receive the FAMES intervention.

干预措施: FAMES (Behavioral)

Attention Control Condition

Active Comparator

225 dyads (family members/support persons and individuals receiving services for psychosis) will be recruited over a period of 18 months to receive 12 weeks of weekly communication via text, email or phone call, which includes positive messaging, community resources, appointment reminders, and psychoeducation.

干预措施: Control (Behavioral)

结局指标

主要结局

Engagement in coordinated specialty care psychoeducation

时间窗: Baseline through study completion; repeated measure to assess change through study completion, average of 3 months

Will be measured as first session attendance rate and total attendance rate per family provided by administrative data from the coordinated specialty care site partners.

Engagement in Family Engagement Strategy

时间窗: Baseline through study completion; repeated measure to assess change through study completion, average of 3 months

Total number of Family Engagement Strategy session attended and the total number of contact minutes to measure engagement.

次要结局

  • Perceived Stress Scale(Baseline through study completion; repeated measure to assess change through study completion, average of 6 months)
  • General Anxiety Disorder - 7(Baseline through study completion; repeated measure to assess change through study completion, average of 6 months)
  • Client Engagement(Baseline through study completion; repeated measure to assess change through study completion, average of 6 months)
  • Client - Patient Health Questionnaire - 9(Baseline through study completion; repeated measure to assess change through study completion, average of 6 months)
  • Family - Patient Health Questionnaire - 9(Baseline through study completion; repeated measure to assess change through study completion, average of 6 months)
  • Community Assessment of Psychic Experiences - Positive Scale 15-items Scale(Baseline through study completion; repeated measure to assess change through study completion, average of 6 months)

研究者

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

Oladunni Oluwoye

Associate Professor

Washington State University

研究点 (4)

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