- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07808099
Turkish Adaptation and Validation of the Parent and Youth Forms of the Ohio Youth Scales
Turkish Adaptation and Evaluation of the Validity and Reliability of the Ohio Mental Health Consumer Outcomes System Youth Problem, Functioning, and Satisfaction Scales (Parent and Youth Forms)
This methodological and descriptive study aims to translate and culturally adapt the Parent and Youth Forms of the Ohio Youth Scales into Turkish and to evaluate the validity and reliability of the Turkish versions. Approximately 300 children and adolescents aged 5-18 years and their parents will participate. The Parent Form will be completed by parents of children and adolescents aged 5-18 years, while the Youth Form will be completed by participants aged 12-18 years.
Emotional, behavioral, and psychosocial factors may directly affect participation in daily activities, social functioning, quality of life, and rehabilitation outcomes, particularly among children and adolescents with neurological or chronic conditions. Therefore, the Turkish versions of the scales are expected to support a more comprehensive assessment of psychosocial functioning and service satisfaction in pediatric rehabilitation.
The adaptation process will include forward translation, reconciliation, back-translation, expert review, and pilot testing. Psychometric analyses will examine internal consistency, construct validity, test-retest reliability, agreement, and responsiveness. No medical intervention, invasive procedure, or biological sample collection will be involved.
Přehled studie
Postavení
Detailní popis
Physiotherapy and rehabilitation aim not only to improve physical functions but also to promote participation in daily activities, social adaptation, and quality of life. According to the International Classification of Functioning, Disability and Health framework, health should be evaluated by considering body structures and functions, activity, participation, and environmental factors. Emotional status, behavioral characteristics, and psychosocial functioning may directly influence rehabilitation, particularly among children and adolescents with neurological or chronic conditions.
The Ohio Youth Scales provide multidimensional assessments of problems, functioning, and satisfaction through Parent and Youth Forms. The Turkish adaptation of these instruments may facilitate the assessment of psychosocial status and social participation among children and adolescents receiving rehabilitation services. The scales may also support physiotherapists within multidisciplinary assessment, contribute to the development of rehabilitation goals that reflect psychosocial needs, and provide valid and reliable instruments for future clinical and academic research.
This methodological and descriptive observational study aims to translate and culturally adapt the Parent and Youth Forms of the Ohio Youth Scales into Turkish and evaluate their psychometric properties. Approximately 300 children and adolescents aged 5-18 years and their parents will voluntarily participate. The Parent Form will be administered to parents of children and adolescents aged 5-18 years, while the Youth Form will be administered to participants aged 12-18 years.
The adaptation process will be conducted in accordance with international guidelines for the cross-cultural adaptation of measurement instruments. First, the original forms will be independently translated from English into Turkish by at least two researchers who are proficient in both languages and knowledgeable in the relevant field. The translations will be compared and reconciled to produce a common Turkish version.
The reconciled Turkish version will then be independently translated back into English by translators who are native English speakers or have advanced proficiency in English and who have not reviewed the original forms. The back-translated versions will be compared with the original instruments to evaluate conceptual equivalence and consistency of meaning.
Expert opinions will subsequently be obtained to evaluate linguistic appropriateness, cultural relevance, and content validity. Necessary revisions will be made based on the expert evaluations, resulting in a preliminary Turkish version. This preliminary version will be pilot-tested with a limited number of individuals from the target population. Participants' understanding of the items will be evaluated, and unclear expressions will be revised before the final Turkish forms are produced.
Data will be collected face-to-face or in another appropriate setting. Completion of the questionnaires is expected to take approximately 15-20 minutes. A second administration will be conducted after a two-week interval to assess test-retest reliability.
The Strengths and Difficulties Questionnaire will be used to assess emotional and behavioral difficulties, and the Psychological Well-Being Scale will be used to assess psychological well-being as part of the validity evaluation. Relationships between the Parent and Youth Forms will also be examined.
Descriptive statistics will include frequencies and percentages for categorical variables and means, medians, standard deviations, and ranges for continuous variables. Internal consistency will be evaluated using Cronbach's alpha coefficients. Construct validity will be examined using confirmatory factor analysis. Test-retest reliability will be evaluated using intraclass correlation coefficients based on a two-way mixed-effects model. Measurement error and agreement will be assessed using the standard error of measurement and minimal detectable change. Responsiveness may be evaluated using Global Rating of Change scores or other appropriate validated measures. Statistical significance will be set at p<0.05.
No medical intervention or invasive procedure will be performed. No biological samples will be collected, and no biochemical, hematological, genetic, or other laboratory examinations will be conducted.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Ceyda Sakalli Physiotherapist and Master's Student
- Telefonní číslo: +90 546 238 38 96
- E-mail: ceyda.sakalli@ogr.iuc.edu.tr
Studijní místa
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Istanbul
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Istanbul, Istanbul, Turecko (Türkiye), 34500
- Istanbul University - Cerrahpasa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
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Kontakt:
- Ceyda Sakalli, Physiotherapist
- Telefonní číslo: +90 546 238 38 96
- E-mail: ceyda.sakalli@ogr.iuc.edu.tr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
Being aged 5-18 years for participation through the Parent Form Being aged 12-18 years for participation through the Youth Form Voluntary participation of the child or adolescent and their parent Provision of written informed consent by the parent Provision of written assent by participants aged 12 years or older Having sufficient Turkish reading and comprehension skills to understand the items For the test-retest assessment, having completed the initial assessment and voluntarily agreeing to complete the second assessment
Exclusion Criteria:
Being outside the specified age range Absence of written informed consent from the parent Absence of written assent from participants aged 12 years or older Insufficient Turkish reading or comprehension skills to understand the items Substantially incomplete or incorrectly completed questionnaires Failure to complete the second assessment, only for inclusion in the test-retest analyses
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Children Aged 5-11 Years
Parents of children aged 5-11 years will complete the Parent Form of the Turkish Ohio Youth Scales.
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Adolescents Aged 12-18 Years
Parents of adolescents aged 12-18 Years will complete the Parent Form, and adolescents will complete the Youth Form of the Turkish Ohio Youth Scales.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Psychometric Properties of the Turkish Ohio Youth Scales Parent Form
Časové okno: At the initial assessment and two weeks after the initial assessment
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The Turkish Parent Form of the Ohio Youth Scales will be completed by parents of children and adolescents aged 5-18 years.
The form assesses the child's or adolescent's problems, functioning, and satisfaction with services.
Its psychometric properties will be evaluated through internal consistency, construct validity, test-retest reliability, measurement error, and agreement analyses.
Internal consistency will be examined using Cronbach's alpha, and test-retest reliability will be assessed using intraclass correlation coefficients.
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At the initial assessment and two weeks after the initial assessment
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Psychometric Properties of the Turkish Ohio Youth Scales Youth Form
Časové okno: At the initial assessment and two weeks after the initial assessment
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The Turkish Youth Form of the Ohio Youth Scales will be completed by adolescents aged 12-18 years.
The form assesses problems, functioning, and satisfaction with services from the adolescent's perspective.
Its psychometric properties will be evaluated through internal consistency, construct validity, test-retest reliability, measurement error, and agreement analyses.
Internal consistency will be examined using Cronbach's alpha, and test-retest reliability will be assessed using intraclass correlation coefficients.
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At the initial assessment and two weeks after the initial assessment
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Convergent Validity With the Strengths and Difficulties Questionnaire
Časové okno: At the initial assessment
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The Strengths and Difficulties Questionnaire will be used to evaluate the convergent validity of the Turkish Ohio Youth Scales.
The validated Turkish Parent Form will be completed by parents of eligible participants, and the validated Turkish self-report form will be completed by eligible adolescents.
Associations between the Strengths and Difficulties Questionnaire scores and the corresponding problem and functioning scores of the Turkish Ohio Youth Scales will be examined.
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At the initial assessment
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Convergent Validity With the Psychological Well-Being Scale
Časové okno: At the initial assessment
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The validated Turkish version of the Psychological Well-Being Scale will be used to support the construct validity of the Turkish Ohio Youth Scales.
Associations between psychological well-being scores and the corresponding scores obtained from the Turkish Ohio Youth Scales will be examined.
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At the initial assessment
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Sezen Karaborklu Argut, PhD, Istanbul University - Cerrahpasa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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