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临床试验/NCT05938998
NCT05938998已完成不适用

Social Support and Stress Reduction for Caregivers of Young Adults With IDD

University of Kansas Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年3月31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
20
试验地点
2
主要终点
Recruitment

研究概览

简要总结

The objective of this study is to evaluate the feasibility and stress reduction impacts of a yoga and support group intervention on caregivers of individuals with intellectual and developmental disabilities.

详细描述

This is a single arm longitudinal trial. We will recruit up to 40 caregivers of young adults with intellectual and developmental disabilities (IDD). This is a 12-week social support, resources, and stress reduction intervention delivered in person to a group of caregivers of young adults IDD. Participants will be asked to attend one 2 hour group session each week. All sessions will have a 1-hour discussion on resources and social support and 1-hour of yoga. All yoga sessions will be taught by 200 Registered Yoga Teacher certified instructors. Outcome assessments will be collected at baseline and after the 12-week intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • 1) caregiver of a young adult with IDD 2) self-reported ability to participate in a yoga class with no contraindications to participation.

排除标准

  • 1) Actively participating in another health lifestyles interventional research study.

结局指标

主要结局

Recruitment

时间窗: Baseline

We will calculate recruitment rate by dividing the number of participants who enroll by those who were found eligible on the questionnaire.

Session Attendance

时间窗: Weeks 1-12 of intervention

The group session leaders will record attendance at weekly sessions. The participants will only be considered present if they complete the entire 2-hour session. The outcome variable will be the number of sessions attended (count) and percentage of attendance out of the total 12 scheduled sessions.

Retention

时间窗: Weeks 1-12 of intervention

Calculated as percentage of participants who completed the out of those who enrolled

Acceptability

时间窗: Between Weeks 12-14

Number of Participants who Found the Intervention Helpful. Semi-structured interviews were conducted with each caregiver to assess satisfaction with the intervention components.

Recruitment

时间窗: Baseline

We will calculate recruitment rate by dividing the number of participants who enroll by those who were found eligible on the questionnaire.

Session Attendance

时间窗: Weeks 1-12 of intervention

The group session leaders will record attendance at weekly sessions. The participants will only be considered present if they complete the entire 2-hour session. The outcome variable will be the number of sessions attended (count) and percentage of attendance out of the total 12 scheduled sessions.

Mean Number of Sessions Attended

时间窗: From baseline to 12 weeks

Mean number of sessions attended out of 12 possible sessions

Retention

时间窗: Weeks 1-12 of intervention

Calculated as percentage of participants who completed the out of those who enrolled

Acceptability

时间窗: Between Weeks 12-14

Number of Participants who Found the Intervention Helpful. Semi-structured interviews were conducted with each caregiver to assess satisfaction with the intervention components.

次要结局

  • Perceived Stress Scale Score(12 weeks)
  • ug/dL Salivary Cortisol(12 weeks)
  • The Multidimensional Scale of Perceived Social Support (MSPSS)(12 weeks)
  • Modified Caregiver Strain Index(12 weeks)
  • The Family Empowerment Scale(12 weeks)
  • The Pittsburgh Sleep Quality Index (PSQI)(12 weeks)
  • Physical Activity(12 weeks)
  • Body Mass Index(12 weeks)

研究者

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

Amy Bodde, PhD, MPH

Research Assistant Professor

University of Kansas Medical Center

研究点 (2)

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