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Набор по приглашению NCT06139874

Thrive Intervention in Schools

Без фазы С лечением Childhood Mental Disorder

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: THRIVE, Parenting Wisely.
Кому может быть актуально
Состояния в реестре: Childhood Mental Disorder. Базовые параметры: 3 лет — 7 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

Promoting Emotional Development Among Young Children Facing Adversity: An Effectiveness Implementation Study in St. Louis Schools

Обзор

This study is designed to test the effectiveness and implementation of an early intervention therapy for children and their primary caregivers by using existing school counselors across several school districts. The intervention is a 6-8 week caregiver-child intervention (THRIVE) which will be conducted via video conference in the family's home (i.e., zoom), or within the school setting (or a combination of those 2 modalities depending upon feasibility for the family). THRIVE will be compared to an asynchronous on-line parenting education program, Parenting Wisely (PW). This online parenting course will be accessed at www.parentingwisely.com. Existing school counselors will be trained in the delivery of THRIVE to 3-7 year old children (in preschool, kindergarten and first grade) and their primary caregivers. In addition to testing the effectiveness of THRIVE compared to PW, we will also compare two implementation strategies: THRIVE-Coached and THRIVE-Low Coached (LC). We will assess ongoing coaching of THRIVE trainees to increase therapist efficacy and adherence to the intervention (THRIVE-Coached). This will be compared to implementation of THRIVE with low supports (e.g. weekly supervision) provided only for the first case following the initial training (THRIVE-LC\]. Compared to those randomized to PW, we expect children who receive THRIVE will have significantly better behavioral and socio-emotional outcomes. Caregivers who receive THRIVE will experience less parenting stress and depression, more optimism and will show more nurturing, emotional tolerance, and supportive caregiving. Therapists in the THRIVE-Coached condition will deliver the intervention with higher achieved outcomes and find the intervention to be more acceptable than therapists in the THRIVE-LC condition. Therapists in the THRIVE-Coached condition will be more likely to plan to sustain the intervention following the completion of the study than those in the THRIVE-LC condition. Parents and children receiving THRIVE from therapists in the THRIVE-Coached condition will have better socio-emotional outcomes than those in the THRIVE-LC and PW conditions.

Вмешательства

  • Поведенческое THRIVE
    Early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention.
  • Поведенческое Parenting Wisely
    Online asynchronous parenting program.

Первичные конечные точки

  • Child Behavior Checklist [Срок оценки: T1 (baseline), T2 (halfway through intervention), T3 (completion of intervention) and T4 (12 weeks post intervention)]
Вторичные конечные точки (4)
  • The Emotion Regulation Checklist [Срок оценки: T1 (baseline), T3 (completion of intervention)]
  • Coping with Children's Negative Emotions Scale [Срок оценки: T1 (baseline), T2 (halfway through intervention), T3 (completion of intervention)]
  • Parenting Stress Index [Срок оценки: T1 (baseline), T3 (completion of intervention)]
  • Parent-Child Observed Interaction Coding [Срок оценки: T1 (baseline), T3 (completion of intervention)]

Критерии участия

Критерии включения

  • Near the clinical threshold on the Teacher or Parent Report Form
  • An active primary caregiver can be identified and is available to participate in the intervention (mother, father, grandparent or any adult in this role)

Критерии исключения

  • Autism
  • Major neurological disorder
  • Participating in active weekly individual or family therapy

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
  • Early Emotional Development Program — St Louis

Публикации

  • Wang S, Quinones H, Miller L, Luby J, Kohl PL. Implementation climate and readiness for the THRIVE intervention in school settings: a mixed methods study. Implement Sci Commun. 2026 Jun 11. doi: 10.1186/s43058-026-01006-w. Online ahead of print. PMID 42277967

Идентификаторы

NCT: NCT06139874 · 202306092

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗