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临床试验/NCT06193382
NCT06193382尚未招募不适用

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

University of Miami2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
2
主要终点
Change in caregiver-perceived child behavior problems as measured by the Eyberg Child Behavior Inventory (ECBI) problem scale

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • - Children with major sensory impairments (e.g., deafness, blindness)
  • Primary Caregiver Exclusion Criteria:
  • - Primary caregiver with major sensory impairments (e.g., deafness, blindness)

研究组 & 干预措施

PCIT Group

Experimental

Participants in this group will receive the PCIT intervention for up to 5 weeks.

干预措施: PCIT (Behavioral)

结局指标

主要结局

Change in caregiver-perceived child behavior problems as measured by the Eyberg Child Behavior Inventory (ECBI) problem scale

时间窗: Baseline and week 5

The ECBI questionnaire will be used to evaluate the number of behavioral problems and the frequency of their occurrence before and after the intervention program. ECBI provides a list of 36 problem behaviors commonly reported by parents. The inventory assesses behavior on two dimensions: 1) the frequency of the behavior; 2) whether parents consider it a problem. The frequency ratings range from 1 (never) to 7 (always), and are summed up to arrive at an overall problem behavior Intensity Score, ranging from 36 to 252. Higher score means more behavioral problems.

Change in parent stress as measured by the Parenting Stress Index Fourth Edition Short Form (PSI-SF) total score

时间窗: Baseline and week 5

PSI-4-SF assesses the parents stress level. PSI-4-SF contains 36 items: 12 items for Parental Stress (PS), 12 items for Parent-Child Dysfunctional Interaction (P-CDI), and 12 items for Difficult Child (DC).The normal range for scores is within the 16th to 84th percentiles.Scores in the 85th to 89th percentile are considered high, and scores in the 90th percentile or higher are considered clinically significant.

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

时间窗: Baseline and week 5

PSI-4-SF assesses the parents stress level.PSI-4-SF contains 36 items: 12 items for Parental Stress (PS) , 12 items for Parent-Child dysfunctional Interaction (P-CDI), and 12 items for Difficult Child (DC).The normal range for scores is within the 16th to 84th percentiles.Scores in the 85th to 89th percentile are considered high,and scores in the 90th percentile or higher are considered clinically significant.

Number of week homework was completed by the caregiver

时间窗: Up to 5 weeks

Number of week homework was completed by the caregiver

Change in parenting skills as measured by the Dyadic Parent-Child Interaction Coding System-Fourth Edition (DPIC-IV)

时间窗: Baseline and week 5

The Dyadic Parent-Child Interaction Coding System-4th Ed is a structured behavioral observation coding system assessing caregiver-child interactions. Observed parenting behaviors will be coded during a 5-min parent-child play session with a tablet with educational apps and combined into two categories of positive (praises, behavior descriptions, and reflections) and negative (questions, commands, and negative talk) verbalizations, reflecting behaviors caregivers are taught to use and avoid in PCIT. The higher the score the higher quality the parenting behavior.

Acceptability of Intervention Measure (AIM)

时间窗: Up to 5 weeks

The Likert scale has 4 items. The scores will be summed to provide a total score. Scores range from completely disagree to completely agree.

Feasibility of Intervention Measure (FIM)

时间窗: Up to 5 weeks

The Likert scale has 4 items. The scores will be summed to provide a total score. Scores range from completely disagree to completely agree.

Change in parent stress as measured by the Parenting Stress Index Fourth Edition Short Form (PSI-SF) Parent Stress (PS) score

时间窗: Baseline and week 5

PSI-4-SF assesses the parents stress level.PSI-4-SF contains 36 items: 12 items for Parental Stress (PS) , 12 items for Parent-Child Dysfunctional Interaction (P-CDI), and 12 items for Difficult Child (DC).The normal range for scores is within the 16th to 84th percentiles.Scores in the 85th to 89th percentile are considered high, and scores in the 90th percentile or higher are considered clinically significant.

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

时间窗: Baseline and week 5

PSI-4-SF assesses the parents stress level.PSI-4-SF contains 36 items: 12 items for Parental Stress (PS) , 12 items for Parent-Child Dysfunctional Interaction (P-CDI), and 12 items for Difficult Child (DC).The normal range for scores is within the 16th to 84th percentiles.Scores in the 85th to 89th percentile are considered high, and scores in the 90th percentile or higher are considered clinically significant.

Treatment satisfaction as measured by the Therapist Attitude Inventory (TAI)

时间窗: Up to 5 weeks

TAI is a valid index of consumer satisfaction for participants in behavioral parent training (BPT). Items are rated on a scale from one (indicating treatment dissatisfaction or lack of improvement) to five (indicating satisfaction with treatment and improvement). Parents will complete this form after the last session of the BPT program. BPT consists of 11 items that are scored on a 5-point Likert scale. The total score range is 11-55; the higher the score, the greater the satisfaction

Number of modules completed by the caregiver

时间窗: Up to 5 weeks

Number of modules completed by the caregiver

Intervention Appropriateness Measure (IAM)

时间窗: Up to 5 weeks

The Likert scale has 4 items. The scores will be summed to provide a total score. Scores range from completely disagree to completely agree.

Change in child behavior problem frequency and severity as measured by the Eyberg Child Behavior Inventory (ECBI) intensity scale

时间窗: Baseline and week 5

The ECBI questionnaire will be used to evaluate the number of behavioral problems and the frequency of their occurrence before and after the intervention program. ECBI provides a list of 36 problem behaviors commonly reported by parents. The inventory assesses behavior on two dimensions: 1) the frequency of the behavior; 2) whether parents consider it a problem. The frequency ratings range from 1 (never) to 7 (always), and are summed up to arrive at an overall problem behavior Intensity Score, ranging from 36 to 252. Higher score means more behavioral problems.

次要结局

  • Change in family functioning as measure by the General Functioning (GF) Scale(Baseline and week 5)
  • Change in child's peer relationship problems as measured by the Strengths and Difficulties Questionnaire (SDQ) peer relationship problems scale(Baseline and week 5)
  • Change in child's functioning as measured by the Strengths and Difficulties Questionnaire (SDQ)(Baseline and week 5)
  • Change in child's hyperactivity/inattention as measured by the Strengths and Difficulties Questionnaire (SDQ) hyperactivity/inattention scale(Baseline and week 5)
  • Change in child's conduct problems as measured by the Strengths and Difficulties Questionnaire (SDQ) conduct problems scale(Baseline and week 5)
  • Change in child's emotional symptoms as measured by the Strengths and Difficulties Questionnaire (SDQ) emotional symptoms scale(Baseline and week 5)
  • Change in child's prosocial behaviors as measured by the Strengths and Difficulties Questionnaire (SDQ) prosocial behavior scale(Baseline and week 5)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dainelys Garcia

Associate Professor of Clinical Pediatrics

University of Miami

研究点 (2)

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