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Набор скоро начнётся NCT07747129

Promoting Physical Activity Among Young Children With Autism

Без фазы С лечением Autism Spectrum Disorder (ASD)

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: Wellness Enhancing Physical Activity for Young Children (WE PLAY), Non-Physical Activity Online Training.
Кому может быть актуально
Состояния в реестре: Autism Spectrum Disorder (ASD). Базовые параметры: 33 мес. — 71 мес. · 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
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Обзор

Higher amounts of physical activity are linked to multiple health benefits including improved cognition, academic success, and classroom behavior for children. These relationships start in early childhood during the preschool years. Additional research is needed to determine the rates of physical activity among children with autism spectrum disorder. However, research suggests that compared to their typically developing peers, children with autism participate in fewer types of physical activities, often have delays in a range of motor skills, and face physical activity barriers including behavior problems, social communication challenges, and adults' uncertainty about how to modify physically active games to include them. Young children need adult guidance, support, and opportunities to be more active, and early care and education programs are a critical setting for physical activity promotion. Faculty at Northeastern University developed and pilot tested WE PLAY (Wellness Enhancing Physical Activity for Young Children), a teacher training, that is accessed online at no cost. WE PLAY was designed to promote physical activity at the child-level, to promote knowledge, confidence, and skills to lead active play at the teacher-level, and to impact social and environmental challenges at the program-level. Three three pilot studies demonstrated that WE PLAY was efficacious in increasing physical activity when implemented with preschoolers with and without autism and it was viewed as feasible, understandable, and acceptable by early childhood educators. This clinical trial will test the efficacy of WE PLAY in children with autism spectrum disorder and their teachers. The researchers hypothesized that at post-training and follow-up, children in the WE PLAY group will engage in higher levels of physical activity in school relative to children in the control group. Further, the researchers hypothesized that at post-training and follow-up teachers in the WE PLAY group will demonstrate increased behavior intentions, perceived behavior control to perform physical activity facilitating behaviors relative to control group teachers. Additionally, this study will explore the effects of malleable teacher and system-level factors between the intervention and child physical activity. The researchers hypothesized that malleable teacher and system variables including behavior intentions, perceived behavior control, physical activity promotion practices, teachers' perceived physical activity promotion role, teacher autonomy, and supervisor support will mediate or moderate the relationship between study group and child physical activity levels. A national sample of 150 teacher-child dyads from early childhood education programs across the United States will be randomized into two conditions (WE PLAY vs. Control). Data will be collected across three periods over 20 weeks (pre-training = 0 weeks, post-training = 4 weeks, follow-up = 20 weeks). WE PLAY teachers will be asked to complete the WE PLAY training. Control group teachers will complete another online training on a topic that is not related to physical activity. Children with autism (ages 2.9 to 5.11) will wear accelerometers during waking hours for five consecutive days at each of the three data collection periods and their teachers will complete online surveys at each of the three data collection periods. The proposed study addresses a critical need for young children with autism. If WE PLAY is determined to be efficacious on a large scale it would lead to interventions that could be integrated in a variety of settings, including early care and education programs and community settings, which could improve physical activity levels in young children, setting them up for greater success throughout their lives.

Вмешательства

  • Поведенческое Wellness Enhancing Physical Activity for Young Children (WE PLAY)
    WE PLAY Is an online training for early childhood educators. The training includes online educational modules, a video library of active games, game sheets, a teacher self-assessment, a supervisor/peer observation form, and other resources/tools designed to include autistic preschoolers in active play with their peers.
  • Поведенческое Non-Physical Activity Online Training
    Participants in this group will complete an online training from a list of options on the Better Kid Care website that are not on the topic of physical activity.

Первичные конечные точки

  • Change from Pre-Training in Children's Physical Activity Assessed by Accelerometry at Post-training and Follow-Up [Срок оценки: Pre-Training (Week 0), Post-Training (Week 4), Follow-Up (Week 20)]
  • Change from Pre-Training in Teachers' Behavioral Intentions as Assessed by an abbreviated version of the Early Childhood Education Movement Behavioral Intention and Perceived Control (ECE-MBIPC) Questionnaire at Post-Training and Follow-Up [Срок оценки: Pre-Training (Week 0), Post-Training (Week 4), Follow-Up (Week 20)]
  • Change from Pre-Training in Teachers' Perceived Behavioral Control as Assessed by the ECE-MBIPC at Post-Training and Follow-Up [Срок оценки: Pre-Training (Week 0), Post-Training (Week 4), Follow-Up (Week 20)]
  • Change from Pre-Training in Teachers' Practices to Promote Physical Activity as Assessed by the Child-Care Food and Activity Practices Questionnaire (CFAPQ) at Post-Training and Follow-Up [Срок оценки: Pre-Training (Week 0), Post Training (Week 4), Follow Up (Week 20)]
  • Change from Pre-Training in Teachers' Practices to Promote Physical Activity as Assessed by the Environment and Policy Assessment and Observation Self-Report Staff General Survey (EPAO-SR) at Post-Training and Follow-Up [Срок оценки: Pre-Training (Week 0), Post-Training (Week 4), Follow-Up (Week 20)]

Критерии участия

Критерии включения

  • Only 1 teacher-child dyad per early childhood education program/school will be enrolled in the study.
  • Teachers are eligible to participate if: they are a lead teacher in a classroom with at least one child with autism; the autistic child's parent/guardian consented for their child to participate; and the teacher has not previously completed WE PLAY.
  • Children are eligible to participate if: they are between the ages of 2.9 - 5.11 years at the pre-training assessment, they have a previous diagnosis of autism, and their teacher is participating.

Критерии исключения

  • Children who do not have a diagnosis of autism, or whose family plans to move away from the area before the study ends will be excluded from the study.

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
Открытое
Основная цель
Лечение

Центры проведения

США · 3 центра
  • Northeastern University — Boston
  • Tufts University/Tufts Medical Center — Boston
  • Pennsylvania State University — University Park

Идентификаторы

NCT: NCT07747129 · 24-08-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗