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Идёт набор NCT05989568

BASIS-T Efficacy Trial

Без фазы С лечением Behavior, Child

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: BASIS-T, Attention Control (ACC).
Кому может быть актуально
Состояния в реестре: Behavior, Child. Базовые параметры: от 18 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
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Официальное название

Supporting Teachers in Implementing Classroom Practices to Build Better Student-Teacher Relationships

Обзор

For the approximately one in five children with social, emotional, and behavioral (SEB) challenges, accessible evidence-based prevention practices (EBPPs) are critical. In the United States, schools are the primary service setting for children's SEB service delivery but EBPPs are rarely adopted or implemented by educators (e.g., teachers) with sufficient fidelity to see effects. Given that individual behavior change is ultimately required for successful implementation, focusing on individual-level processes holds promise as a parsimonious approach to enhance adoption. Beliefs and Attitudes for Successful Implementation in Schools for Teachers (BASIS-T) is a pragmatic, multifaceted pre-implementation strategy targeting volitional and motivational mechanisms of educators' behavior change to enhance implementation and student SEB outcomes. This study protocol describes a hybrid type 3 effectiveness-implementation trial designed to evaluate the main effects, mediators, and moderators of the BASIS-T implementation strategy in the context of Positive Greetings at the Door (PGD), a universal school-based EBPP previously demonstrated to reduce student disruptive behavior and increase academic engagement.

Вмешательства

  • Поведенческое BASIS-T
    BASIS-T is designed to address the behavioral components often missing from standard EBPP training and consultation that relate to motivation prior to receiving EBPP training, and volition after EBPP training. It is an EBPP-agnostic implementation strategy designed to be delivered within the Preparation/Adoption phase, immediately prior to Active Implementation (CITE EPIS). BASIS-T targets behavioral intentions via improvement in attitudes, subjective norms, and self-efficacy.
  • Поведенческое Attention Control (ACC)
    Teachers assigned to the ACC will receive pre- and post-training experiences designed to mirror those received in the BASIS-T condition. These training experiences will be virtual, delivered by the same interventionist, and be approximately the same length as the BASIS-T experiences, but will not contain any of the BASIS-T content or mechanisms of change. The ACC pre-training experience will define, describe, and advocate for EBP implementation in schools. Content will be didactic, as is typical

Первичные конечные точки

  • Proximal Outcome: Attitudes [Срок оценки: Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months]
  • Proximal Outcome: Subjective Norms [Срок оценки: Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months]
  • Proximal Outcome: Self-Efficacy [Срок оценки: Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months]
  • Proximal Outcome: Intentions to Implement [Срок оценки: Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months]
  • Implementation Outcome: Adoption [Срок оценки: 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months]
  • Implementation Outcome: Fidelity and Sustainment - Observed [Срок оценки: Beginning of School Year, Mid-School Year, End of School Year]
  • Implementation Outcome: Fidelity and Sustainment - Self Report [Срок оценки: Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months]
  • Implementation Outcome: Reach [Срок оценки: Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months]
Вторичные конечные точки (2)
  • Student Educational Outcomes [Срок оценки: 9-months]
  • Student Behavioral Outcomes [Срок оценки: Baseline, 2-weeks, 4-weeks, 2-months, 3-months, 4-months, 5-months, 6-months, 9-months, 15-months]

Критерии участия

Критерии включения

  • Being a K-5th grade teacher at an elementary or K-8 school, and not a teacher in a special education-only classroom

Критерии исключения

  • Having been trained or supervised on delivering PGD in the past 5 years

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • University of Washington — Seattle

Публикации

  • Lyon AR, Cook CR, Larson M, Hugh ML, Dopp A, Hamlin C, Reinke P, Bose M, Law A, Goosey R, Goerdt A, Morrell N, Wackerle-Hollman A, Pullmann MD. Protocol for a hybrid type 3 effectiveness-implementation trial of a pragmatic individual-level implementation strategy for supporting school-based prevention programming. Implement Sci. 2024 Jan 2;19(1):2. doi: 10.1186/s13012-023-01330-y. PMID 38167046

Идентификаторы

NCT: NCT05989568 · STUDY00017371

Первоисточники (государственные реестры)

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