Life Change EventsNCT02356263
Adaptation and Validation of Recent Life Changes Questionnaire for Measuring Stress Among Adults in Karachi, Pakistan
An observational study of Life Change Events, run by Aga Khan University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Life Change Events
- How many people
- 300 participants
- Where
- 1 sitePakistan
- Study dates
- Mar 2015to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Those who do not understand Urdu
- Those who have cognitive or hearing difficulties
- People with known psychiatric conditions and are under treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation and Validation of Recent Life Changes Questionnaire (RLCQ) to Measure Stress Among Adult Population of Karachi, Pakistan.
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.
Read the 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.
- Conditions
- Life Change Events
- Keywords
- stressful events, psychological stress, life experiences
- Medical subject headings
- Stress, Psychological
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity, as measured by Positive and Negative Predictive Value, Kappa Statistics
sensitivity and specificity of the RLCQ will be compared against gold standard MINI
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Life Change EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ayeesha Kamran Kamal, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356263
- Sponsor's protocol ID
- 3235-CHS-ERC-14
- Status last verified
- Aug 2016
- First submitted
- 28 Jan 2015
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 31639054Artani 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.
PubMed 28476102
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Validation of Recent Life Changes Questionnaire (RLCQ) to Measure Stress Among Adult Population of Karachi, Pakistan.
- ClinicalTrials.gov ID
- NCT02356263
- Acronym / sponsor ID
- 3235-CHS-ERC-14
- Conditions
- Life Change Events
- Keywords
- stressful events, psychological stress, life experiences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Those who do not understand Urdu
- Those who have cognitive or hearing difficulties
- People with known psychiatric conditions and are under treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Derived from this study: PubMed 31639054Artani 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.
- Derived from this study: PubMed 28476102Artani 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.
Related trials for Life Change Events
Active, not recruiting
Longitudinal Study of Neighborhood Social Event Attendance at Renovated Parks and Changes in Sleep, Stress, and Well-being
Sleep, Well-being
RecruitingObservational study
Impact of the Coronavirus (COVID-19) on Patients With Cancer
Cancer, COVID-19
Not yet recruitingObservational study
Global Survey on Newborns' HOspitalisation and Parental Experiences - the HOPE Study
Infant, Premature, Infant, Low Birth Weight
RecruitingObservational study
The Lake Nona Life Project
Health Behavior, Quality of Life
RecruitingObservational study
Factors Affecting the Quality of Life After Ischemic Stroke in Young Adults
Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Life Change Events, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity, as measured by Positive and Negative Predictive Value, Kappa Statistics (time frame: 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02356263, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.