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Adaptation and Validation of Recent Life Changes Questionnaire for Measuring Stress Among Adults in Karachi, Pakistan

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ClinicalTrials.gov Identifier: NCT02356263
Recruitment Status : Completed
First Posted : February 5, 2015
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Ayeesha Kamran Kamal, Aga Khan University

Tracking Information
First Submitted Date January 28, 2015
First Posted Date February 5, 2015
Last Update Posted Date August 8, 2016
Study Start Date March 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 2, 2015)
Sensitivity and specificity, as measured by Positive and Negative Predictive Value, Kappa Statistics [ Time Frame: 11 months ]
sensitivity and specificity of the RLCQ will be compared against gold standard MINI
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Adaptation and Validation of Recent Life Changes Questionnaire for Measuring Stress Among Adults in Karachi, Pakistan
Official Title Adaptation and Validation of Recent Life Changes Questionnaire (RLCQ) to Measure Stress Among Adult Population of Karachi, Pakistan.
Brief Summary

Stressors impair optimum function of an individual physiologically and psychologically. Overcoming stress is possible when one knows which aspects of life are the most troublesome to manage for individuals. There are certain tools available in Pakistan that can measures stress in selected populations but there are no validated tools that may quantify stress which results from events occurring in different aspects of life.

Recent Life Changes Questionnaire (RLCQ) is a tool that measures stress of individuals through life changing events. It has five categories; work, home and family, health, personal and social and financial. The objective of the study is to adapt RLCQ and validate it so that it may measure stress among people living in Karachi, Pakistan.

Detailed Description

In order to make RLCQ a tool to measure stress within Pakistani context, we would want to adapt RLCQ and then validate it. The study design is a validation study where the construct of recent life changing events will be validated by comparing it with a gold standard to assess the extent of accuracy of measurement by exploring the agreement between them. The mode of data collection is cross-sectional by administering the adapted RLCQ and the gold standard simultaneously. Since stress is a subjective phenomenon and serves as a root cause for many neurodegenerative diseases and mental disorders, a tool for screening mental illnesses is selected against which we could compare the adapted RLCQ for validation. The Mini international neuropsychiatric Interviews (MINI) is a structured diagnostic interview developed and validated by Sheehan in 1997, Florida. It is based on the DSM IV criteria and ICD-10. The design of this study incorporates content and criterion validity as we have a pre-existing 'gold standard' which is widely accepted and is in current practice of mental health screening in Pakistan.

The study will be conducted in six phases. Phase I includes conducting qualitative interviews to explore the phenomenon. In Phase II, adaptation of RLCQ will be done and review of the adapted tool will be done with the help of subject experts. Phase III will verify the face validity of the tool by translations and back translations. In Phase IV, pre-testing of the tool will be done whereas in phase V, we will administer the tool in the community along with conducting MINI interviews. Phase VI tests the reliability of the tool.

Study Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The target population for the study includes all adults aged 18 years or above living in Karachi, Pakistan. The source population is that of all adults aged 18 years or above living in Gulshan-e-Iqbal town Karachi from where we will draw our sample population comprising of those adults 18 years or more who fulfil the eligibility criteria and consent to participate in the study.
Condition Life Change Events
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 2, 2015)
300
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adults aged 18 years or above
  • Those who would stay in the study site for at least one month
  • Those who provide a written informed consent

Exclusion Criteria:

  • Those who do not understand Urdu
  • Those who have cognitive or hearing difficulties
  • People with known psychiatric conditions and are under treatment.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02356263
Other Study ID Numbers 3235-CHS-ERC-14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Ayeesha Kamran Kamal, Aga Khan University
Study Sponsor Aga Khan University
Collaborators Not Provided
Investigators Not Provided
PRS Account Aga Khan University
Verification Date August 2016