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临床试验/NCT03263923
NCT03263923已完成不适用

GIFT Web Based Resourcefulness Training for Grandmother Caregivers

Case Western Reserve University2 个研究点 分布在 1 个国家目标入组 346 人开始时间: 2017年8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
346
试验地点
2
主要终点
SF-12 Mental Health Composite Score

研究概览

简要总结

CWRU Research Study: Looking for grandmothers living with grandchildren, 18 years of age or younger, to take part in a study to compare methods of dealing with the stress of caregiving to grandchildren. Participants need to have daily access to a computer, complete four surveys online, and be willing to write in a journal every day for a month. Participants will be compensated for their time.

详细描述

This is a randomized clinical trial that will compare two methods of dealing with stress of grandparent caregiving to grandchildren.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants randomly assigned to groups

入排标准

性别
Female
接受健康志愿者

入选标准

  • Grandmother to one or more grandchildren (age 18 or younger) living in the same home (with or without parents)

排除标准

  • Grandmothers to grandchildren who do not share their home
  • Not a grandmother
  • Not living in the United States.

结局指标

主要结局

SF-12 Mental Health Composite Score

时间窗: Baseline vs 24 week followup

Normed score generated by vendor-provided software using all 12 items of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores indicating better mental health. Note: the SF-12 measures 8 health domains (Physical Function, Bodily Pain, Vitality, Role-Emotional, Role-Physical, General Health, Social Function, Mental Health) across 12 individual response questions. All 12 responses are normed for gender, and country of origin and differentially weighted to calculate scores for both physical and mental health.

Depressive Symptoms

时间窗: comparison of baseline with 24 weeks post journaling completion

Center for Epidemiologic Disease - Depression Scale (CES-D) Radloff, 1977. Composite item derived from 20 item scale. Individual items are scored on a 4 point likert scale (0-3). Individual items are summed and possible scale scores range from 0-60. Higher scores represent greater depressive symptoms. Scores of 16 or greater are interpreted as indicating an increased risk of diagnosis of clinical depression.

Family Well Being - Composite Score Derived From 12 Items.

时间窗: comparison of baseline with 24 weeks post journaling

General Family Functioning 12 item subscale of the McMaster Family Assessment Device (FAD). Participants respond on a 5 point likert scale. The subscale is the mean of the participant's responses to the 12 items with possible composite scores of 0-5. Higher scores indicate worse family well being.

Well Being

时间窗: comparison of baseline with 24 weeks post journaling

SF 12 individual item: overall self-appraised health. This is a single response item "In general, would you say your health is..." Participants respond on 5 point scale with response options ranging from Poor (1) to Excellent (5). Higher scores indicate better self-appraised health.

SF-12 Physical Health Composite Score

时间窗: Baseline vs 24 week followup

Normed score generated by vendor-provided software using all 12 items of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores indicating better physical health. Note: the SF-12 measures 8 health domains (Physical Function, Bodily Pain, Vitality, Role-Emotional, Role-Physical, General Health, Social Function, Mental Health) across 12 individual response questions. All 12 responses are normed for gender, and country of origin and differentially weighted to calculate scores for both physical and mental health.

次要结局

未报告次要终点

研究者

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

Carol M. Musil

Principal Investigator

Case Western Reserve University

研究点 (2)

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