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Идёт набор NCT06827951

Potential Benefits of Parent Child Interaction Therapy (PCIT)

Наблюдательное Autonomic Dysregulation Anxiety Depression Parent-Child Relations

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-Child Interaction Therapy (PCIT).
Кому может быть актуально
Состояния в реестре: Autonomic Dysregulation, Anxiety, Depression, Parent-Child Relations. Базовые параметры: 18 лет — 89 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 →
Официальное название

A Mixed-Methods Approach Utilizing Self-Report Scales and Oxytocin Levels to Determine the Potential Benefits of Parent Child Interaction Therapy (PCIT)

Обзор

The goal of this study is to explore possible benefits of Parent-Child Interaction Therapy (PCIT). The main goals of the study are: * To investigate whether pre-survey measures of autonomic reactivity relate to the overall functioning of participants. * To examine the effects of PCIT To identify individual characteristics that influence the effects of PCIT. Participants will: * complete 5 online surveys (1x pre-PCIT, 3x during PCIT, and 1x post-PCIT) * complete the PCIT program

Подробное описание

It is the specific intent of this proposal to experimentally explore the possible benefits and mechanisms through which PCIT can influence self-reported stress and autonomic and neuroendocrine functioning in parents. This will be accomplished by our team by using well-validated self-report measures of mental health, autonomic reactivity, parental stress and attachment, and non-invasive measurements of levels of oxytocin.

Specific Aim 1: To investigate whether pre-intervention measures of ANS reactivity and the neuropeptides oxytocin relate to the overall functioning of the participants.

* The investigators will examine how measures of autonomic reactivity and levels of oxytocin relate to prior mental/medical health. * Hypothesis: Participants with lower levels of oxytocin and/or increased autonomic reactivity will report being more impacted by their prior adversity and having more emotional/physical symptoms.

Specific Aim 2: To investigate the impact of PCIT

* The investigators will explore whether PCIT leads to improvements in parental stress, parent-child attachment, and parental neuroendocrine functioning. * Hypothesis: Parents will show a significant decrease in perceived stress and improvement in emotional wellbeing oxytocin levels following CDI. They will also show a decrease in perceived stress, and improvement in attachment and emotional wellbeing following the entire PCIT intervention.

Specific Aim 3: To identify individual characteristics that influence the effectiveness of PCIT.

* The investigators will explore the impact of specific vulnerability and resiliency factors (e.g., stress, prior adversity) on how well parents benefit from PCIT * Hypothesis: Parental stress and prior mental/medical adversity will negatively impact the effectiveness of intervention

Вмешательства

  • Поведенческое Parent-Child Interaction Therapy (PCIT)
    Participants will undergo the standard PCIT program, which consists of two phases: Child-Directed Interaction (CDI) and Parent-Directed Interaction (PDI). * CDI Phase: Parents will learn and practice techniques that focus on strengthening the parent-child relationship through play and positive reinforcement. * PDI Phase: Parents will be coached in effective discipline strategies to manage their child's behavioral problems.

Первичные конечные точки

  • Measuring Change in Autonomic Reactivity using the Body Perceptions Inventory Short Form [Срок оценки: Through study completion, an average of 20 weeks]
  • Assessing the Impact of Adversity History [Срок оценки: Up to 1 week]
  • Measuring change in oxytocin Levels [Срок оценки: Up to 4 weeks]
  • Measuring change in parental stress using the parental stress scale [Срок оценки: Through study completion, an average of 20 weeks]
  • Measuring change in parental attachment using the Child-Parent Relationship Scale [Срок оценки: Through study completion, an average of 20 weeks]
  • Measuring change in child behavior using the parent-report Eyberg Child Behavior Inventory [Срок оценки: Through study completion, an average of 20 weeks]
  • Measuring change in anxiety using the General Anxiety Disorder-7 [Срок оценки: Through study completion, an average of 20 weeks]
  • Measuring change in depression using the Patient Health Questionnaire-8 [Срок оценки: Through study completion, an average of 20 weeks]
  • Measuring change in post-traumatic stress symptoms using the PTSD Checklist for DSM-5 [Срок оценки: Up to 1 week]

Критерии участия

Критерии включения

  • Parents of children aged 2-7 years old who are eligible for Parent-Child Interaction Therapy (PCIT) based on behavioral concerns.
  • The primary caregiver of the child and be actively involved in the child's daily care.
  • Willing to attend all PCIT sessions and complete pre-, mid- and post-intervention assessments.
  • Fluent in English to ensure comprehension of the intervention and assessment materials.

Критерии исключения

  • Parents with diagnosed severe mental health disorders (e.g., schizophrenia, bipolar disorder) that may interfere with participation in PCIT.
  • Children with conditions that require interventions other than PCIT (e.g., severe developmental disabilities).
  • Parents who have previously participated in PCIT are excluded to avoid confounding results.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 2 центра
  • UF Health Child Psychiatry — Gainesville
  • UF Health Psychiatry San Jose — Jacksonville

Идентификаторы

NCT: NCT06827951 · IRB202400867

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗