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Набор по приглашению NCT07203014

Parent-Educator Action Response

Без фазы С лечением Attention Deficit and Disruptive Behavior 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: Parent-Educator Action Response (PEAR), Daily Report Card.
Кому может быть актуально
Состояния в реестре: Attention Deficit and Disruptive Behavior Disorders. Базовые параметры: Без ограничений · 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 →
Официальное название

Testing a Brief, Engagement Focused Intervention for Parents and Educators in Preschool: Parent-Educator Action Response

Обзор

The goal of this clinical trial is to learn if a new adjunctive intervention, Parent-Educator Action Response (PEAR), works to improve teacher and family engagement in school-based interventions for child attention deficit/hyperactivity disorder (ADHD) and disruptive behavior symptoms. This clinical trial will also be used to refine implementation procedures to inform a larger clinical trial.

Подробное описание

School-based behavioral interventions are well-established treatments for preschool children who display elevated ADHD symptoms, regardless of a diagnosis, and are the recommended first line of treatment according to the American Academy of Pediatrics. However, teachers and families face barriers to implementing behavioral interventions with the recommended frequency and fidelity. The investigators are proposing to test a new adjunctive intervention that is aimed at improving teacher and family implementation of school-based interventions for preschool disruptive behavior and ADHD symptoms. The investigators will be testing PEAR plus a school-based intervention (Daily Report Card; DRC) in a pilot roll-out implementation optimization (ROIO) trial with three clusters (groups of schools) across two years.

Adjunctive Intervention (PEAR). All participating parents and teachers will complete PEAR. PEAR consists of three group sessions (one for caregivers and one for educators) followed by a meeting with each caregiver-educator dyad.

Daily Report Card. The primary goal of PEAR is to improve teacher and family implementation of an evidence-based practice for ADHD symptoms in preschool. The investigators have decided to focus on implementation of the Daily Report Card. Following consent, teachers will receive handouts on the Daily Report Card and will be asked to implement it for the child whose parents are in PEAR. Teachers and parents will be asked to complete weekly reports measuring teacher and family daily use of the DRC starting at BL through the 4-week follow up (8 weeks total).

Assessment Procedures. Assessments will be completed at three time points: BL (week 0), post-PEAR (4 weeks from BL), and follow-up (8 weeks from BL). At each assessment, participating legal guardians and teachers will complete rating scales electronically via RedCap, a scalable, secure, enterprise-level application for data collection. Interviews: Qualitative interviews with parents and teachers who participate in PEAR will be conducted to understand their experiences and identify potential areas for improvement.

Analytic Approach. This clinical trial will specifically examine the acceptability, feasibility and promise of PEAR and refine and optimize trial procedures. Basic data screening and descriptive analyses will be conducted for all variables, and the investigators will screen for errors, distributional form, and missing data. For all models, the investigators will check assumptions to ensure that results are not an artifact of violations. Below are analytic details for each aim of the trial:

Is PEAR and the implementation strategies acceptable and feasible? Overall, PEAR acceptability and feasibility for all participants will be evaluated by examining the mean parent and teacher ratings of satisfaction, acceptability, appropriateness, and feasibility. Consumer fit will be considered acceptable if scores are above the neutral point of the scale for all measures except fidelity, which the investigators will consider 80% as the target point. The investigators will also examine whether acceptability and feasibility indices vary by classroom and participant demographics by treating these predictors as fixed effects in regression analyses.

Are the ROIO trial procedures acceptable and feasible? This aim is focused on (a) refining recruitment procedures and study protocol to obtain an adequate sample of parents, (b) optimizing screening and assessment procedures in preschool, and (c) optimizing procedures for sustaining participants in PEAR (i.e., minimizing drop-out).

Does PEAR improve teacher and family fidelity to the Daily Report Card? The investigators will collect daily (weekdays only) counts of family and teacher implementation of the Daily Report Card starting at BL through follow-up (8 weeks total). Fidelity will be defined as the proportion of weekdays the Daily Report Card is implemented at home, school, and both. The investigators are interested in examining the change in fidelity across time. Hierarchical multi-level models will be used to ensure inclusion of random effects, variations between clusters, variation between times within cluster, and fixed effects of time which will be estimated independently of treatment effect, so that systematic change over time will not be mistaken for the effect of treatment.

Вмешательства

  • Поведенческое Parent-Educator Action Response (PEAR)
    PEAR is a novel adjunctive intervention aimed at improving teacher and family implementation of classroom-based interventions for child ADHD symptoms and disruptive behavior in preschool.
  • Поведенческое Daily Report Card
    The Daily Report Card is a behavioral intervention for children with challenging behaviors, and provides a structure for teachers and caregivers to support a child with reducing challenging behaviors and increasing positive behaviors. The DRC has been shown to be highly effective in reducing ADHD symptoms.

Первичные конечные точки

  • Daily Report Card Check-In [Срок оценки: Baseline to 8-week follow-up]
Вторичные конечные точки (11)
  • Preschool Pediatric Symptom Checklist [Срок оценки: Baseline, 4-week, 8-week follow-ups.]
  • Preschool ADHD Rating Scale Version IV (ADHD-RS-IV) [Срок оценки: Baseline, 4-week, 8-week follow-ups.]
  • Teacher-Parent Joining [Срок оценки: Baseline, 4-week, 8-weeks follow-ups.]
  • Teacher Self-Efficacy for Classroom Behavior Management [Срок оценки: Baseline, 4-week, 8-week follow-ups.]
  • Teacher Burnout [Срок оценки: Baseline, 4-week, 8-week follow-ups.]
  • Racial Awareness, Beliefs, and Attitudes [Срок оценки: Baseline, 4-week, 8-week follow-ups.]
  • Parent Self-Efficacy [Срок оценки: Baseline, 4-week, 8-week follow-ups.]
  • Parenting Stress [Срок оценки: Baseline, 4-week, 8-week follow-ups.]
  • Top Problems [Срок оценки: 4-week and 8-week follow-ups.]
  • Expulsion Risk [Срок оценки: Baseline, 4-week, 8-week follow-ups.]
  • Implementation Outcomes [Срок оценки: 4-week follow-up.]

Критерии участия

Критерии включения

  • Teacher or legal guardian/caregiver of a preschool-aged child between 2-5 years old
  • Child has behavioral challenges in the classroom or needs support with social-emotional development
  • Teacher participants must be fluent in English
  • Caregiver participants may be fluent in English or Spanish.

Критерии исключения

  • Teacher or legal guardian/caregiver of a child who is not 2-5 years old
  • Child does not have behavioral challenges or does not need support with social-emotional development
  • Teacher participants who are not fluent in English
  • Caregiver participants who are not fluent in either English or Spanish

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago

Публикации

  • Eisenman SR, Vanegas J, Cicchetti C, Compton SN, Gilliam WS, Iruka IU, Lyon AR, Wakschlag LS, Smith JD, Spencer AE, Zulauf-McCurdy CA. A pilot Roll-Out Implementation Optimization trial of an adjunctive intervention to improve teacher and caregiver uptake and adherence to a behavioral intervention for externalizing problems in preschool: a study protocol of Parent-Educator Action Response (PEAR). PMID 42021370

Идентификаторы

NCT: NCT07203014 · STUDY00000176 · K23MH129575

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗