Tele-PCIT for Healthy Relationships in Families At-Risk

Официальное название

Fostering Healthy Relationships Through Tele-PCIT for Families of South Carolina

Обзор

The study will examine Parent Child Interaction Therapy (PCIT) delivered via telehealth (Tele-PCIT) for young children at risk for adverse childhood experiences and/or trauma exposure.

Подробное описание

This randomized controlled trial evaluates the feasibility, acceptability, engagement, and initial efficacy of time-limited Parent Child Interaction Therapy (PCIT) delivered via telehealth (Tele-PCIT) across 40 young children at risk for adverse childhood experiences and/or trauma exposure. The study compares outcomes between families receiving Tele-PCIT (n = 20) and those assigned to a waitlist control (n = 20). All families will complete baseline, post, and follow-up evaluations to assess child behavioral outcomes, parenting outcomes, and trauma symptoms. In order to be eligible children are between 2 and 7 years of age presenting with behavioral concerns and scoring at-risk on childhood averse events measures.

Вмешательства

• Поведенческое Telehealth Parent Child Interaction Therapy
  During tele-PCIT, therapists coach parents on parenting strategies while they play with their child during one hour weekly sessions. The first phase of therapy focuses on increasing positive behaviors and the second phase focuses on decreasing negative behaviors with discipline strategies. The therapist and the family will be connected through a video feed on either a phone, tablet, or computer and a Bluetooth headset.
• Поведенческое Telehealth Parent Child Interaction Therapy (Delayed Start)
  Delayed start of 12-weeks for delivery of Tele-PCIT. During tele-PCIT, therapists coach parents on parenting strategies while they play with their child during one hour weekly sessions. The first phase of therapy focuses on increasing positive behaviors and the second phase focuses on decreasing negative behaviors with discipline strategies. The therapist and the family will be connected through a video feed on either a phone, tablet, or computer and a Bluetooth headset.

Первичные конечные точки

• Parenting Practices [Срок оценки: Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up]
• Child Behavior [Срок оценки: Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up]
• Trauma Related Symptoms [Срок оценки: Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up]

Критерии участия

Критерии включения

• Child participants must:

• Be between 2:0-6:11 years old
• Have elevated levels of disruptive behavior problems as defined by the Eyberg Child Behavior Inventory (ECBI)
• Have receptive language appropriate for PCIT (approximately 2-years old)
• Medicaid eligible, or be uninsured
• Score of 1 or greater on an ACEs (adverse childhood experiences) measure (PEARLS)
• Parent participants must:

• Be the child's legal guardian
• Be able to provide consent for themselves (i.e., have decision making capacity and do not need a legally authorized representative themselves).
• Must be living with the child

Критерии исключения

• None

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

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Rutledge Tower — Charleston

Идентификаторы

NCT: NCT07225010 · Pro00146035 · 2167-SP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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