- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02356263
Adaptation and Validation of Recent Life Changes Questionnaire for Measuring Stress Among Adults in Karachi, Pakistan
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Karachi, Pakistan
- Aga Khan University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Zeitperspektiven: Querschnitt
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Sensitivity and specificity, as measured by Positive and Negative Predictive Value, Kappa Statistics
Zeitfenster: 11 months
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sensitivity and specificity of the RLCQ will be compared against gold standard MINI
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11 months
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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 3235-CHS-ERC-14
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