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

• ClinicalTrials.gov Identifier: NCT02356263
• Recruitment Status: Completed
• First Posted: February 5, 2015
• Last Update Posted: August 8, 2016
• Sponsor: Aga Khan University
• 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
• 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 *

• Artani A, Kamal AK, Azam SI, Artani M, Bhamani SS, Saif M, Khan FA, Alam N. Validation of the Recent Life Changes Questionnaire (RLCQ) for stress measurement among adults residing in urban communities in Pakistan. BMC Psychol. 2019 Oct 21;7(1):66. doi: 10.1186/s40359-019-0341-9.
• Artani A, Bhamani SS, Azam I, AbdulSultan M, Khoja A, Kamal AK. Adaptation of the Recent Life Changes Questionnaire (RLCQ) to measure stressful life events in adults residing in an urban megapolis in Pakistan. BMC Psychiatry. 2017 May 5;17(1):169. doi: 10.1186/s12888-017-1315-1.

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

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