Culturally Adapted Family Intervention For Psychosis
Pilot Study of Culturaly Adapted Family Intervention for Psychosis
Aim:
To assess the feasibility of culturally adapted Family Intervention for Psychosis.
Design:
Randomized Control Trial
Setting:
psychiatric department of different hospitals
Participants:
A total of 36 caregivers of Psychosis patients will be randomized to psychological Intervention and treatment as usual arm.
Intervention:
Culturally Adapted Family Intervention for Psychosis
Outcome measure:
Positive and Negative syndrome scale (PANSS) Experience of care -giving inventory(ECI) Care Well-Being & Support(CWS)
研究概览
详细说明
The purpose of the study is to test the feasibility of culturally adaptive family intervention for Psychosis
Primary Objective :
- To test whether Pakistani families caring for someone with psychosis will engage with a model of family intervention which has been culturally adapted to meet their needs.
- To evaluate the acceptability of the intervention to the families who receive it and to gather feedback regarding any changes that might improve the intervention.
- To gain an impression of whether the intervention has the potential to address unmet psychological and social needs of the families and how this affects their levels of stress
the investigators will conduct a feasibility pilot study to test whether Pakistani families offered the intervention will want to receive it. The Participants will be recruited from psychiatric department of different hospitals. They will be randomly divided into two groups; intervention group and treatment-as-usual group. A total of thirty six participants will be recruited in the pilot study and divided equally into two arms. This will ensure that, even after loss to follow-up, we will have at least 12 subjects per group for analysis (FDA guidance http://www.fda.gov/cder/guidance/5356fnl.pdf).Randomization will be carried out by the on offsite statistician. This will provide a reliable geographically remote service. For intervention group ten sessions of family intervention will be provided by trained research clinician during the period of three months. Relatives of Patients in the treatment as usual (TAU) group will be given details of intervention at the end of the study and interested families will be offered family intervention
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Sindh,
-
Karachi、Sindh,、巴基斯坦
- Dow University of Health Sciences
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Living with or with at least 10 hours per week face to face contact with an individual with psychosis who has a caring role. Plus the individual with psychosis themselves.
- Individuals aged between 18-65.
- Resident of Karachi.
- Participant is able to give informed written consent.
Exclusion Criteria:
- Severe drug or alcohol problem (i.e., those who fulfill the criteria for dependence according to ICD10 RDC).
Unstable residential arrangements such that the likelihood of being available for the duration of the trial is low.
.
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Family Intervention
Culturally Adapted Family intervention for Psychosis Sessions will be offered weekly basis
|
This 10 session Multi-modal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component
其他名称：
|
|
无干预：Control
Caregiver ' s Patients who will be randomized to the "treatment as usual" arm will receive routine care
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Positive and Negative syndrome scale (PANSS)
大体时间：six months
|
The PANSS is a structured clinical interview consisting of 30 items designed to assess severity of symptoms over the past week on a 7-point scale.
|
six months
|
|
Experience of Care-giving inventory(ECI)
大体时间：six months
|
Commonly apply to persons who care for relative or friends With a serious mental illness
|
six months
|
|
Carer Wel-Being & Support(CWS)
大体时间：six months
|
A questionnaire for carers of people with a mental Health problem
|
six months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Family Questionnaire(FQ)
大体时间：six months
|
Find out the problem of caregiver for relative or friends With a serious mental illness.
|
six months
|
|
Insight rating scale
大体时间：six months
|
Assesses Improvement in insight
|
six months
|
|
Calgary Depression Scale for Schizophrenia
大体时间：six months
|
This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia
|
six months
|
|
Short Explanatory Model Interview
大体时间：six months
|
used to elicit beliefs of mental illness
|
six months
|
合作者和调查者
调查人员
- 首席研究员：Imran Chaudhry, MD、University of Manchester
- 首席研究员：Nusrat Husain, MD、Pakistan Institute of Learning and Living, University of Manchester
- 首席研究员：Farooq Naeem, MRCPsych、Pakistan Institute of Learning and Living, University of Southampton
- 首席研究员：Munir Hamirani, FCPS、Abbasi Shaheed Hospital
- 首席研究员：Raza Ur Rehman, FCPS、Dow University of Health Sciences
- 首席研究员：Ajmal kazm、Pakistan Institute of Living and Learning
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Family intervention的临床试验
-
Ege Miray Topcu完全的
-
Seung-Jung ParkCardioVascular Research Foundation, Korea终止
-
University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)尚未招聘
-
University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University完全的
-
University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人