- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07740863
Occupational Therapy Intervention in Children Diagnosed With Early and Late Autism Spectrum Disorder
Comparison of the Effects of Occupational Therapy Intervention on Sensory Processing and Executive Functions in Children Diagnosed With Early and Late Autism Spectrum Disorder
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- being between 6 and 12 years of age
- having a formal diagnosis of ASD
- actively attending occupational therapy sessions.
Exclusion Criteria:
- Children with severe physical disabilities, significant visual or hearing impairments, or severe cognitive and communication limitations preventing participation in the assessment process were excluded.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Контрольная группа
|
A pediatric occupational therapy intervention will be applied to improve children's performance and independence in daily living activities. The intervention will be structured according to the child's individual needs, functional capacity, developmental level, and difficulties in daily living activities. The intervention program will use activities aimed at supporting the child's performance in areas such as self-care, feeding, dressing, toileting, personal care, functional mobility, and participation in daily living routines. During the intervention process, the child's existing skills will be evaluated, and activities suitable for the child will be planned in line with activity analysis and a task-oriented approach. The intervention program will generally include the following components: Assessment of the child's performance in daily living activities Setting individual goals Activity analysis and activity-based intervention Working on self-care and daily living skills |
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Экспериментальный: Study Group
Occupational Therapy Group
|
A pediatric occupational therapy intervention will be applied to improve children's performance and independence in daily living activities. The intervention will be structured according to the child's individual needs, functional capacity, developmental level, and difficulties in daily living activities. The intervention program will use activities aimed at supporting the child's performance in areas such as self-care, feeding, dressing, toileting, personal care, functional mobility, and participation in daily living routines. During the intervention process, the child's existing skills will be evaluated, and activities suitable for the child will be planned in line with activity analysis and a task-oriented approach. The intervention program will generally include the following components: Assessment of the child's performance in daily living activities Setting individual goals Activity analysis and activity-based intervention Working on self-care and daily living skills |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Sociodemographic form
Временное ограничение: 4 weeks
|
age at diagnosis, weekly therapy frequency, total number of occupational therapy sessions, and sociodemographic data were recorded for all participants.
All assessment forms were completed by caregivers during face-to-face interviews conducted before and after the intervention period.
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4 weeks
|
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Sensory Processing Measure-Home (SPM-Home)
Временное ограничение: 4 weeks
|
The Sensory Processing Measure - Home Form (SPM-H) is a caregiver-reported questionnaire designed to evaluate sensory processing and related functional behaviors in children aged 5 to 12 years (Parham & Ecker, 2007).
The form consists of 75 items and is completed by parents or primary caregivers in approximately 15-20 minutes.
The SPM-H assesses several sensory domains, including vision, hearing, touch, body awareness, and balance and motion.
These subscales contribute to a total sensory score.
In addition, the scale includes social participation and planning/ideas subscales, which reflect higher-order integrative functions influenced by sensory processing.
Items are rated on a four-point frequency scale ranging from "never" to "always," with higher scores indicating greater sensory processing difficulties.
Raw scores are converted into standardized T-scores, which are interpreted as typical performance, some problems, or definite dysfunction.
The Turkish adaptation of the scale demon
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4 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Dunn Sensory Profile
Временное ограничение: 4 weeks
|
The Dunn Sensory Profile is a caregiver-reported questionnaire developed to evaluate sensory processing patterns in children aged 3 to 10 years (Ermer & Dunn, 1998).
It consists of 125 items assessing multiple sensory domains, including auditory, visual, vestibular, tactile, multisensory, and oral sensory processing.
The questionnaire is completed by caregivers who have regular contact with the child in daily life.
Each item is rated on a 5-point frequency scale ranging from "always" to "never."
Higher scores in each subdomain indicate greater difficulties in sensory processing.
The Turkish adaptation of the scale was conducted by Kayıhan et al., demonstrating satisfactory psychometric properties, with Cronbach's alpha coefficients ranging between 0.63 and 0.97 across subdomains.
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4 weeks
|
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Executive Function Occupational Routine Scale (EFORTS)
Временное ограничение: 4 weeks
|
The scale is a parent-reported measure designed to assess children's executive functioning through everyday routines.
It evaluates executive control within three domains: (a) morning and evening routines, (b) play and leisure activities, and (c) social routines.
Parents rate 30 items using a 5-point Likert scale ranging from 1 (never) to 5 (always).
Subscale and total scores are calculated by averaging item responses, with higher scores indicating better executive functioning in daily occupational performance.
The scale also provides a cut-off score to identify the presence of executive dysfunction.
EFORTS can be completed by parents in approximately 15 minutes in various settings.
In the original validation study by Frisch and Rosenblum (2014), internal consistency was high, with subscale reliability coefficients ranging from 0.83 to 0.92 and an overall Cronbach's alpha of 0.947.
Turkish validity and reliability were conducted by Akyurek et al. (2023).
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4 weeks
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- AFSU
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .