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Набор скоро начнётся NCT06193382

Parent-Child Interaction Therapy (PCIT) for Children With Traumatic Brain Injury (TBI): A Stepped-Care Model

Без фазы С лечением Traumatic Brain Injury Disruptive Behavior

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: PCIT.
Кому может быть актуально
Состояния в реестре: Traumatic Brain Injury, Disruptive Behavior. Базовые параметры: от 2 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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Обзор

The purpose of this study is to understand how a stepped-care model of Parent-Child Interaction Therapy (Step-Up PCIT) addresses child behavioral problems among children between the ages of 2 and 7 with a traumatic brain injury (TBI).

Вмешательства

  • Поведенческое PCIT
    Participants will receive the adapted Pocket PCIT Online via a web-based learning platform for up to 5 weeks. Participants will engage in this intervention weekly for about 1 hour per week. During engaging with the adapted Pocket PCIT Online version of PCIT, caregivers will learn positive parenting skills to increase the warmth of the parent-child relationship as well as strategies to effectively set limits. Participants will also participate in 15-minute check-in phone calls with a therapist ea

Первичные конечные точки

  • Change in child behavior problem frequency and severity as measured by the Eyberg Child Behavior Inventory (ECBI) intensity scale [Срок оценки: Baseline and week 5]
  • Change in caregiver-perceived child behavior problems as measured by the Eyberg Child Behavior Inventory (ECBI) problem scale [Срок оценки: Baseline and week 5]
  • Change in parent stress as measured by the Parenting Stress Index Fourth Edition Short Form (PSI-SF) total score [Срок оценки: Baseline and week 5]
  • Change in parent stress as measured by the Parenting Stress Index Fourth Edition Short Form (PSI-SF) Parent Stress (PS) score [Срок оценки: Baseline and week 5]
  • Change in parent-child dysfunctional interaction as measured by the Parenting Stress Index Fourth Edition Short Form (PSI-SF) Parent-Child Dysfunctional Interaction (P-CDI) score [Срок оценки: Baseline and week 5]
  • Change in how the caregiver perceptions about how it is to care for the child as measured by the Parenting Stress Index Fourth Edition Short Form (PSI-SF) Difficult Child (DC) score [Срок оценки: Baseline and week 5]
  • Change in parenting skills as measured by the Dyadic Parent-Child Interaction Coding System-Fourth Edition (DPIC-IV) [Срок оценки: Baseline and week 5]
  • Treatment satisfaction as measured by the Therapist Attitude Inventory (TAI) [Срок оценки: Up to 5 weeks]
  • Number of modules completed by the caregiver [Срок оценки: Up to 5 weeks]
  • Number of week homework was completed by the caregiver [Срок оценки: Up to 5 weeks]
Вторичные конечные точки (7)
  • Change in family functioning as measure by the General Functioning (GF) Scale [Срок оценки: Baseline and week 5]
  • Change in child's functioning as measured by the Strengths and Difficulties Questionnaire (SDQ) [Срок оценки: Baseline and week 5]
  • Change in child's emotional symptoms as measured by the Strengths and Difficulties Questionnaire (SDQ) emotional symptoms scale [Срок оценки: Baseline and week 5]
  • Change in child's conduct problems as measured by the Strengths and Difficulties Questionnaire (SDQ) conduct problems scale [Срок оценки: Baseline and week 5]
  • Change in child's hyperactivity/inattention as measured by the Strengths and Difficulties Questionnaire (SDQ) hyperactivity/inattention scale [Срок оценки: Baseline and week 5]
  • Change in child's peer relationship problems as measured by the Strengths and Difficulties Questionnaire (SDQ) peer relationship problems scale [Срок оценки: Baseline and week 5]
  • Change in child's prosocial behaviors as measured by the Strengths and Difficulties Questionnaire (SDQ) prosocial behavior scale [Срок оценки: Baseline and week 5]

Критерии участия

Child Inclusion Criteria:

  • Child is between the ages of 2 and 7
  • Child has a mild to moderate TBI

Primary Caregiver Inclusion Criteria:

  • Primary caregiver is 18 years or older
  • Primary caregiver speaks and reads in either English or Spanish

Child Exclusion Criteria:

\- Children with major sensory impairments (e.g., deafness, blindness)

Primary Caregiver Exclusion Criteria:

\- Primary caregiver with major sensory impairments (e.g., deafness, blindness)

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
Лечение

Центры проведения

США · 1 центр
  • University of Miami — Miami

Идентификаторы

NCT: NCT06193382 · 20230405

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗