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Набор по приглашению NCT07321327

Implementation Strategies for Caregiver and Teacher Use of Behavioral Interventions: Aim 2

Без фазы С лечением Attention Deficit Hyperactivity Disorder Symptoms

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: Positive Behavior Management Toolkit for Caregivers, Positive Behavioral Management Toolkit for Teachers.
Кому может быть актуально
Состояния в реестре: Attention Deficit Hyperactivity Disorder Symptoms. Базовые параметры: от 4 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 →

Обзор

The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support caregivers in using behavioral interventions for children with hyperactive, inattentive, or impulsive behaviors, when provided as an adjunct to a resource package for teachers. Participating children will be randomized at the classroom level to one of two conditions: a) their teacher and caregiver receive the resource package, or b) only their teacher receive the resource package. The research team will examine teacher and caregiver implementation outcomes and mental health outcomes for enrolled children.

Подробное описание

Evidence-based interventions for children with or at-risk for Attention Deficit Hyperactivity Disorder (ADHD) include antecedent- and consequence- based behavioral interventions in both the classroom and home settings as well as effective home-school communication approaches. Schools are a promising setting in which to provide early intervention for mental health challenges and to increase access to mental health care. Furthermore, stronger integration between home- and school- based interventions has the potential to meaningfully improve child outcomes. However, there are substantial implementation challenges to caregivers' use of these evidence-based interventions. The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support caregivers in using behavioral interventions for children with hyperactive, inattentive, or impulsive behaviors, when provided as an adjunct to a resource package for teachers. Participating children will be randomized at the classroom level to one of two conditions: a) both teacher and caregiver receive the resource package, or b) only the teacher receive the resource package. The research team will examine teacher and caregiver implementation outcomes and mental health outcomes for enrolled children.

Вмешательства

  • Поведенческое Positive Behavior Management Toolkit for Caregivers
    The Positive Behavior Management Toolkit for Caregivers, or the implementation strategy resource package for caregivers, is a set of resources provided that aims to support their use of evidence-based behavior management practices and home-school communication strategies.
  • Поведенческое Positive Behavioral Management Toolkit for Teachers
    The Positive Behavior Management Toolkit for Teachers, or the implementation strategy resource package for teachers, is a set of resources provided that aims to support their use of evidence-based behavior management practices and home-school communication strategies.

Первичные конечные точки

  • Feasibility of Intervention Measure - Caregiver Report [Срок оценки: Endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Feasibility of Intervention Measure - Teacher Report [Срок оценки: Endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Acceptability of Intervention Measure - Caregiver Report [Срок оценки: Endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Acceptability of Intervention Measure - Teacher Report [Срок оценки: Endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Intervention Appropriateness Measure - Caregiver Report [Срок оценки: Endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Intervention Appropriateness Measure - Teacher Report [Срок оценки: Endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Change in teacher-report child performance [Срок оценки: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Change in caregiver-report child performance [Срок оценки: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Change in teacher-reported parent-teacher relationship [Срок оценки: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Change in caregiver-reported parent-teacher relationship [Срок оценки: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)]
Вторичные конечные точки (4)
  • Change in Caregiver-reported ADHD symptoms [Срок оценки: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Change in Teacher-reported ADHD symptoms [Срок оценки: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Change in Student-Teacher Relationship [Срок оценки: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)]
  • Change in academic success [Срок оценки: Baseline, endpoint (i.e., at least 8 weeks from resource package receipt)]

Критерии участия

Teacher Inclusion criteria

  • A K-5 teacher at a participating school
  • Informed consent

Child Inclusion Criteria

  • Is in a K-5 (ages 4-13 years) class of a participating teacher
  • Nominated for participation by the participating teacher
  • Identified by their participating teacher as displaying functional impairment from ADHD symptoms, as measured by a score of a 3 or greater on the modified version of the Impairment Rating Scale.
  • Informed consent and assent if appropriate

Child Exclusion Criteria

  • Special education classification of 'intellectual disability'
  • Presents as in acute risk of harm to self or others, such that participation in the study is clinically inappropriate because the child warrants more intensive intervention
  • Students from families in which there is not a caregiver who speaks English will be excluded because the focus of this study is developing an English-language version of the resource package

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
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Children's Hospital of Philadelphia — Philadelphia

Идентификаторы

NCT: NCT07321327 · 25-023858

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗