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Идёт набор NCT07076264

Water Competency Intervention in Autism

Без фазы С лечением Autism Spectrum Disorders

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: AquOTic.
Кому может быть актуально
Состояния в реестре: Autism Spectrum Disorders. Базовые параметры: 5 лет — 9 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Water Competency Intervention for Children on the Autism Spectrum: The AquOTic Hybrid Effectiveness Implementation Trial

Обзор

AquOTic is an evidence-based, occupational therapy-led intervention designed to enhance water competency and swim safety skills in children on the autism spectrum. The 10-week program consists of weekly 60-minute group sessions, each including six children paired in a 1:1 ratio with an interventionist. Sessions follow a structured routine involving six rotating stations, targeting various swim and safety skills, with the flexibility for individualized support by the interventionist. Overall, this study has 3 major aims. The first aim evaluates the effectiveness of the AquOTic intervention in improving water competency and swim skills, while comparing outcomes between two implementation models: professional student interventionists (occupational and physical therapy students) and trained community-based interventionists. A total of 108 autistic children will be enrolled and randomly assigned to one of three groups: (1) AquOTic with professional student interventionists, (2) AquOTic with community interventionists, or (3) a control group receiving no AquOTic intervention. The second aim explores the mediators and moderators of the intervention outcomes to assess fidelity and efficacy. The third aim identifies the cost and resources associated with AquOTic. A cost analysis will be conducted to evaluate the resources required for implementation and to inform the development of a scalable, cost-effective drowning prevention strategy for autistic populations.

Вмешательства

  • Другое AquOTic
    AquOTic is an evidence-based, occupational therapy-led intervention designed to enhance water competency and swim safety skills in children on the autism spectrum. The 10-week program consists of weekly 60-minute group sessions, each including six children paired in a 1:1 ratio with an interventionist. Sessions follow a structured routine involving six rotating stations, targeting various swim and safety skills, with the flexibility for individualized support by the interventionist.

Первичные конечные точки

  • Water Orientation Test-Alyn (WOTA) 2 [Срок оценки: At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic]
Вторичные конечные точки (3)
  • Water Orientation Test-Alyn (WOTA) 1 [Срок оценки: At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic]
  • Water Competency Checklist (WCC) [Срок оценки: At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic]
  • Canadian Occupational Performance Measure (COPM) [Срок оценки: At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic]

Критерии участия

Children Participants (n=108)

Критерии включения

  • Educational or medical diagnosis of autism
  • Age between 5 - 9 years
  • Having vision and hearing within normal limits with or without corrective modifications

Критерии исключения

  • Children who demonstrate swim proficiency, as defined by the ability to tread water for 1 minute or move the body through the water without flotation
  • Open wounds or infectious skin diseases
  • Allergy to chlorine
  • Severe co-occurring motor impairments or neurological conditions such as uncontrolled seizures, Rett's or Angelman's syndrome
  • The family is unable to commit to the sessions or evaluations

Interventionists (n=64)

Критерии включения

  • Aged 18 or over
  • Demonstrate swim proficiency, as defined by the ability to tread water for 1 minute and move the body through the water without flotation for 25 yards

Критерии исключения

  • Open wounds or infectious diseases
  • Failed background check
  • Unable to commit to Basic Swim Instructor and AquOTic training (\~40 hours) and 10 AquOTic sessions (20 hours)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • The Ohio State University — Columbus

Публикации

  • Kemp E, Nikahd M, Howard M, Darragh A, Crasta JE. Improving water competency among children on the autism spectrum: the AquOTic randomized controlled trial. Front Pediatr. 2024 Oct 7;12:1473328. doi: 10.3389/fped.2024.1473328. eCollection 2024. PMID 39435387
  • Kemp E, Juckett L, Sansone IO, Walton KM, Palettas M, Carson TB, Crasta JE. AquOTic: protocol for a type 1 hybrid effectiveness-implementation trial of an occupational therapy-based water competency intervention for children on the autism spectrum. BMJ Open. 2026 Aug 4;16(8):e117908. doi: 10.1136/bmjopen-2026-117908. PMID 42552003

Идентификаторы

NCT: NCT07076264 · STUDY20250101 · E06288.1a

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗