Fostering Healthy Relationships Through Tele-PCIT for Families of South Carolina
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Parenting Practices
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Tele-PCIT
Families in the Tele-PCIT condition will recieve a time limited (10 session) version of PCIT via telehealth.
干预措施: Telehealth Parent Child Interaction Therapy (Behavioral)
Waitlist Control
Delayed Start of Tele-PCIT
干预措施: Telehealth Parent Child Interaction Therapy (Delayed Start) (Behavioral)
结局指标
主要结局
Parenting Practices
时间窗: Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up
Measured by the Parenting Scale. The parenting scale is comprised of 30 items rated 1-7 with specific items being averaged to create composites for Laxness, Verbosity, and Overreactivity. Higher scores on each scale indicate higher levels of each parenting behavior.
Child Behavior
时间窗: Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up
Measured by Eyberg Child Behavior Inventory. The ECBI is comprised of 36 items ranging from 1 to 7 and the overall score has a a minimum of 36 and maximum of 252 with higher scores indicating higher behavioral challenges.
Trauma Related Symptoms
时间窗: Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up
Measured by the Child and Adolescent Trauma Screen. The CATS contains 15 items measuring traumatic events, 20 items measuring DSM-5 PTSD symptoms, and 5 items measuring psychosocial functioning, with a range of 0-48 and higher scores indicating greater symptoms.
次要结局
未报告次要终点
研究者
Rosmary Ros-Demarize
Associate Professor-Faculty
Medical University of South Carolina